Trial Outcomes & Findings for Efficacy of Intra-articular Collagen Injection in Patients With Knee Joint Pain Compared to Normal Saline Injection (NCT NCT02539095)
NCT ID: NCT02539095
Last Updated: 2026-04-17
Results Overview
100 mm Visual Analogue Score (VAS) is measurement instrument for subjective characteristics or attitudes that cannot be directly measured. In this trial, it is used for quantification of the pain on the defected knee. The VAS score of the investigational group and the control group at 24 weeks after injection will be compared and analyzed. Score range: 0 \~ 100 mm Higher score indicates the worse outcome. In this case, participant is feeling more pain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
200 participants
Primary outcome timeframe
24 weeks after injection
Results posted on
2026-04-17
Participant Flow
Participant milestones
| Measure |
CartiZol, Collagen Injection
Their eligibility to participate in the study is checked, and they are randomized into the intra-articular collagen injection group based on a randomization table.
CartiZol: The product, CartiZol, which contains absorbable collagen, is applied on the cartilage defect to stimulate the neovasculization and cell penetration and to assist the natural wound healing process. It supplements the defective or damaged cartilage. Place the needle on the tip of the syringe and inject the product into the articular cavity.
|
Normal Saline Injection
Their eligibility to participate in the study is checked, and they are randomized into the (placebo) injection group based on a randomization table.
Normal saline: 1) Supplementation of fluid and electrolytes (sodium or chlorine deficiency) 2) Diluent for injection solution Place the needle on the tip of the syringe and inject the product into the articular cavity.
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
99
|
|
Overall Study
COMPLETED
|
88
|
85
|
|
Overall Study
NOT COMPLETED
|
13
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Intra-articular Collagen Injection in Patients With Knee Joint Pain Compared to Normal Saline Injection
Baseline characteristics by cohort
| Measure |
CartiZol, Collagen Injection
n=101 Participants
Their eligibility to participate in the study is checked, and they are randomized into the intra-articular collagen injection group based on a randomization table.
CartiZol: The product, CartiZol, which contains absorbable collagen, is applied on the cartilage defect to stimulate the neovasculization and cell penetration and to assist the natural wound healing process. It supplements the defective or damaged cartilage. Place the needle on the tip of the syringe and inject the product into the articular cavity.
|
Normal Saline Injection
n=99 Participants
Their eligibility to participate in the study is checked, and they are randomized into the (placebo) injection group based on a randomization table.
Normal saline: 1) Supplementation of fluid and electrolytes (sodium or chlorine deficiency) 2) Diluent for injection solution Place the needle on the tip of the syringe and inject the product into the articular cavity.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.61 years
STANDARD_DEVIATION 9.79 • n=130 Participants
|
59.83 years
STANDARD_DEVIATION 9.84 • n=132 Participants
|
59.22 years
STANDARD_DEVIATION 9.81 • n=130 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=130 Participants
|
77 Participants
n=132 Participants
|
151 Participants
n=130 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=130 Participants
|
22 Participants
n=132 Participants
|
49 Participants
n=130 Participants
|
|
Region of Enrollment
South Korea
|
101 Participants
n=130 Participants
|
99 Participants
n=132 Participants
|
200 Participants
n=130 Participants
|
PRIMARY outcome
Timeframe: 24 weeks after injection100 mm Visual Analogue Score (VAS) is measurement instrument for subjective characteristics or attitudes that cannot be directly measured. In this trial, it is used for quantification of the pain on the defected knee. The VAS score of the investigational group and the control group at 24 weeks after injection will be compared and analyzed. Score range: 0 \~ 100 mm Higher score indicates the worse outcome. In this case, participant is feeling more pain.
Outcome measures
| Measure |
CartiZol, Collagen Injection
n=101 Participants
Their eligibility to participate in the study is checked, and they are randomized into the intra-articular collagen injection group based on a randomization table.
CartiZol: The product, CartiZol, which contains absorbable collagen, is applied on the cartilage defect to stimulate the neovasculization and cell penetration and to assist the natural wound healing process. It supplements the defective or damaged cartilage. Place the needle on the tip of the syringe and inject the product into the articular cavity.
|
Normal Saline Injection
n=99 Participants
Their eligibility to participate in the study is checked, and they are randomized into the (placebo) injection group based on a randomization table.
Normal saline: 1) Supplementation of fluid and electrolytes (sodium or chlorine deficiency) 2) Diluent for injection solution Place the needle on the tip of the syringe and inject the product into the articular cavity.
|
|---|---|---|
|
100 mm Visual Analogue Score (VAS)
|
32.11 score on a scale
Standard Deviation 25.84
|
41.14 score on a scale
Standard Deviation 26.01
|
SECONDARY outcome
Timeframe: at the screening visit, 4, 12, and 24 weeks after injectionWestern Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a set of standarized questionnaires to evaluate the condition of patients with osteoarthritis. The WOMAC score of the investigational group and the control group at baseline, 4 weeks, 12 weeks, and 24 weeks after injection will be compared and analyzed. Score range: 0 \~ 100 Higher score indicates the worse outcome.
Outcome measures
| Measure |
CartiZol, Collagen Injection
n=101 Participants
Their eligibility to participate in the study is checked, and they are randomized into the intra-articular collagen injection group based on a randomization table.
CartiZol: The product, CartiZol, which contains absorbable collagen, is applied on the cartilage defect to stimulate the neovasculization and cell penetration and to assist the natural wound healing process. It supplements the defective or damaged cartilage. Place the needle on the tip of the syringe and inject the product into the articular cavity.
|
Normal Saline Injection
n=99 Participants
Their eligibility to participate in the study is checked, and they are randomized into the (placebo) injection group based on a randomization table.
Normal saline: 1) Supplementation of fluid and electrolytes (sodium or chlorine deficiency) 2) Diluent for injection solution Place the needle on the tip of the syringe and inject the product into the articular cavity.
|
|---|---|---|
|
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index )
12 weeks
|
20.30 score on a scale
Standard Deviation 14.82
|
23.51 score on a scale
Standard Deviation 13.38
|
|
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index )
baseline
|
33.50 score on a scale
Standard Deviation 12.93
|
36.68 score on a scale
Standard Deviation 12.15
|
|
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index )
4 weeks
|
23.59 score on a scale
Standard Deviation 12.94
|
26.02 score on a scale
Standard Deviation 12.65
|
|
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index )
24 weeks
|
20.04 score on a scale
Standard Deviation 15.37
|
22.85 score on a scale
Standard Deviation 14.04
|
SECONDARY outcome
Timeframe: at the screening visit, 4, 12, and 24 weeks after injection36-ltem Short-Form Health Survey (SF-36) is a patient-reported survey of patient health to determine the cost-effectiveness of a health treatment. The SF-36 score of the investigational group and the control group at baseline, 4 weeks, 12 weeks, and 24 weeks after injection will be compared and analyzed. Score range: 0 \~ 100 Higher score indicates a better outcome.
Outcome measures
| Measure |
CartiZol, Collagen Injection
n=101 Participants
Their eligibility to participate in the study is checked, and they are randomized into the intra-articular collagen injection group based on a randomization table.
CartiZol: The product, CartiZol, which contains absorbable collagen, is applied on the cartilage defect to stimulate the neovasculization and cell penetration and to assist the natural wound healing process. It supplements the defective or damaged cartilage. Place the needle on the tip of the syringe and inject the product into the articular cavity.
|
Normal Saline Injection
n=99 Participants
Their eligibility to participate in the study is checked, and they are randomized into the (placebo) injection group based on a randomization table.
Normal saline: 1) Supplementation of fluid and electrolytes (sodium or chlorine deficiency) 2) Diluent for injection solution Place the needle on the tip of the syringe and inject the product into the articular cavity.
|
|---|---|---|
|
36-ltem Short-Form Health Survey (SF-36)
24 weeks
|
66.79 score on a scale
Standard Deviation 16.36
|
65.18 score on a scale
Standard Deviation 14.67
|
|
36-ltem Short-Form Health Survey (SF-36)
baseline
|
55.00 score on a scale
Standard Deviation 13.70
|
54.85 score on a scale
Standard Deviation 14.18
|
|
36-ltem Short-Form Health Survey (SF-36)
4 weeks
|
64.50 score on a scale
Standard Deviation 14.89
|
64.49 score on a scale
Standard Deviation 13.75
|
|
36-ltem Short-Form Health Survey (SF-36)
12 weeks
|
65.20 score on a scale
Standard Deviation 16.30
|
64.46 score on a scale
Standard Deviation 13.09
|
SECONDARY outcome
Timeframe: at 4, 12, and 24 weeks after injectionThe improvement level of the investigational group and the control group will be evaluated by patients at the completion of clinical trial according to the 5 grade evaluation table. The difference of the improvement level (excellent+good+ moderate/total) of the two groups obtained at the completion of clinical trial will be compared and analyzed by z-test. In addition, the improvement level at each time point will be compared and analyzed.
Outcome measures
| Measure |
CartiZol, Collagen Injection
n=101 Participants
Their eligibility to participate in the study is checked, and they are randomized into the intra-articular collagen injection group based on a randomization table.
CartiZol: The product, CartiZol, which contains absorbable collagen, is applied on the cartilage defect to stimulate the neovasculization and cell penetration and to assist the natural wound healing process. It supplements the defective or damaged cartilage. Place the needle on the tip of the syringe and inject the product into the articular cavity.
|
Normal Saline Injection
n=99 Participants
Their eligibility to participate in the study is checked, and they are randomized into the (placebo) injection group based on a randomization table.
Normal saline: 1) Supplementation of fluid and electrolytes (sodium or chlorine deficiency) 2) Diluent for injection solution Place the needle on the tip of the syringe and inject the product into the articular cavity.
|
|---|---|---|
|
Number of Patients Who Are Satisfied With Improvement Assessed by Self-evaluation
4 weeks
|
65 Participants
|
64 Participants
|
|
Number of Patients Who Are Satisfied With Improvement Assessed by Self-evaluation
12 weeks
|
72 Participants
|
66 Participants
|
|
Number of Patients Who Are Satisfied With Improvement Assessed by Self-evaluation
24 weeks
|
72 Participants
|
57 Participants
|
SECONDARY outcome
Timeframe: at 4, 12, and 24 weeks after injectionThe improvement level of the investigational group and the control group will be evaluated by clinicians at the completion of clinical trial according to the 5 grade evaluation table. The difference of the improvement level (excellent+good+ moderate/total) of the two groups obtained at the completion of clinical trial will be compared and analyzed by z-test. In addition, the improvement level at each time point will be compared and analyzed.
Outcome measures
| Measure |
CartiZol, Collagen Injection
n=101 Participants
Their eligibility to participate in the study is checked, and they are randomized into the intra-articular collagen injection group based on a randomization table.
CartiZol: The product, CartiZol, which contains absorbable collagen, is applied on the cartilage defect to stimulate the neovasculization and cell penetration and to assist the natural wound healing process. It supplements the defective or damaged cartilage. Place the needle on the tip of the syringe and inject the product into the articular cavity.
|
Normal Saline Injection
n=99 Participants
Their eligibility to participate in the study is checked, and they are randomized into the (placebo) injection group based on a randomization table.
Normal saline: 1) Supplementation of fluid and electrolytes (sodium or chlorine deficiency) 2) Diluent for injection solution Place the needle on the tip of the syringe and inject the product into the articular cavity.
|
|---|---|---|
|
Number of Patients With Satisfying Improvement Assessed by Physicians
4 weeks
|
62 Participants
|
70 Participants
|
|
Number of Patients With Satisfying Improvement Assessed by Physicians
12 weeks
|
73 Participants
|
67 Participants
|
|
Number of Patients With Satisfying Improvement Assessed by Physicians
24 weeks
|
73 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: at the screening visit, 4, 12, and 24 weeks after injectionPopulation: Physical examination was assessed for each participant at each visit. The analysis population includes all participants who underwent the assessment in each arm/group. The overall number of participants analyzed represents the actual number of participants evaluated (101 in the CartiZol group and 99 in the normal saline group). Each participant was counted once per parameter at each time point.
Physical examination was performed by the investigator at each visit (baseline, 4 weeks, 12 weeks, and 24 weeks). Selected key parameters were evaluated and categorized by severity. Each participant was assigned to a single category for each parameter at each time point, and the number of participants in each category was summarized for each arm/group. ※ Category titles are presented as: "Examination item (e.g., AP alignment)" - "Condition (e.g., varus or valgus)".
Outcome measures
| Measure |
CartiZol, Collagen Injection
n=101 Participants
Their eligibility to participate in the study is checked, and they are randomized into the intra-articular collagen injection group based on a randomization table.
CartiZol: The product, CartiZol, which contains absorbable collagen, is applied on the cartilage defect to stimulate the neovasculization and cell penetration and to assist the natural wound healing process. It supplements the defective or damaged cartilage. Place the needle on the tip of the syringe and inject the product into the articular cavity.
|
Normal Saline Injection
n=99 Participants
Their eligibility to participate in the study is checked, and they are randomized into the (placebo) injection group based on a randomization table.
Normal saline: 1) Supplementation of fluid and electrolytes (sodium or chlorine deficiency) 2) Diluent for injection solution Place the needle on the tip of the syringe and inject the product into the articular cavity.
|
|---|---|---|
|
Physical Examination
Baseline : 7) Lachman's Test - severe
|
0 participants
|
0 participants
|
|
Physical Examination
Baseline : 9) Posterior Drawer Test - mild
|
1 participants
|
0 participants
|
|
Physical Examination
Baseline : 9) Posterior Drawer Test - severe
|
0 participants
|
0 participants
|
|
Physical Examination
Baseline : 10) Valgus stress test 0 - none
|
98 participants
|
98 participants
|
|
Physical Examination
Baseline : 10) Valgus stress test 0 - mild
|
2 participants
|
1 participants
|
|
Physical Examination
Baseline : 10) Valgus stress test 0 - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
Baseline : 10) Valgus stress test 0 - severe
|
1 participants
|
0 participants
|
|
Physical Examination
Baseline : 11) Valgus stress test 30 - none
|
99 participants
|
98 participants
|
|
Physical Examination
Baseline : 11) Valgus stress test 30 - mild
|
2 participants
|
1 participants
|
|
Physical Examination
Baseline : 11) Valgus stress test 30 - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
Baseline : 11) Valgus stress test 30 - severe
|
0 participants
|
0 participants
|
|
Physical Examination
Baseline : 13) Varus stress test 30 - none
|
100 participants
|
98 participants
|
|
Physical Examination
Baseline : 13) Varus stress test 30 - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
Baseline : 13) Varus stress test 30 - severe
|
0 participants
|
0 participants
|
|
Physical Examination
Baseline : 16) PF compression/grinding test - none
|
71 participants
|
76 participants
|
|
Physical Examination
Baseline : 17) Joint line tenderness_Med.ant - mild
|
25 participants
|
36 participants
|
|
Physical Examination
Baseline : 17) Joint line tenderness_Med.ant - severe
|
1 participants
|
0 participants
|
|
Physical Examination
Baseline : 18) Joint line tenderness_Med.mid - none
|
39 participants
|
38 participants
|
|
Physical Examination
Baseline : 18) Joint line tenderness_Med.mid - moderate
|
22 participants
|
19 participants
|
|
Physical Examination
Baseline : 18) Joint line tenderness_Med.mid - severe
|
3 participants
|
3 participants
|
|
Physical Examination
Baseline : 19) Joint line tenderness_Med.post - none
|
57 participants
|
59 participants
|
|
Physical Examination
4 weeks : 13) Varus stress test 30 - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
Baseline : 19) Joint line tenderness_Med.post - severe
|
2 participants
|
6 participants
|
|
Physical Examination
Baseline : 20) Joint line tenderness_Lat.ant - mild
|
19 participants
|
16 participants
|
|
Physical Examination
Baseline : 20) Joint line tenderness_Lat.ant - moderate
|
2 participants
|
2 participants
|
|
Physical Examination
Baseline : 20) Joint line tenderness_Lat.ant - severe
|
0 participants
|
0 participants
|
|
Physical Examination
Baseline : 22) Joint line tenderness_Lat.post - mild
|
6 participants
|
9 participants
|
|
Physical Examination
Baseline : 22) Joint line tenderness_Lat.post - severe
|
0 participants
|
1 participants
|
|
Physical Examination
Baseline : 23) Medial compartment crepitation/pain - none
|
90 participants
|
83 participants
|
|
Physical Examination
Baseline : 23) Medial compartment crepitation/pain - mild
|
9 participants
|
13 participants
|
|
Physical Examination
Baseline : 23) Medial compartment crepitation/pain - moderate
|
1 participants
|
1 participants
|
|
Physical Examination
Baseline : 23) Medial compartment crepitation/pain - severe
|
1 participants
|
2 participants
|
|
Physical Examination
Baseline : 24) Lateral compartment crepitation/pain - none
|
84 participants
|
84 participants
|
|
Physical Examination
Baseline : 24) Lateral compartment crepitation/pain - mild
|
9 participants
|
8 participants
|
|
Physical Examination
Baseline : 24) Lateral compartment crepitation/pain -moderate
|
8 participants
|
7 participants
|
|
Physical Examination
Baseline : 24) Lateral compartment crepitation/pain - severe
|
0 participants
|
0 participants
|
|
Physical Examination
4 weeks : 1) AP Alignment - Varus
|
66 participants
|
54 participants
|
|
Physical Examination
4 weeks : 1) AP Alignmet - Valgus
|
35 participants
|
45 participants
|
|
Physical Examination
4 weeks : 2) Joint Space Narrowing - none
|
15 participants
|
13 participants
|
|
Physical Examination
4 weeks : 2) Joint Space Narrowing - mild
|
52 participants
|
56 participants
|
|
Physical Examination
4 weeks : 2) Joint Space Narrowing - severe
|
4 participants
|
3 participants
|
|
Physical Examination
4 weeks : 3) Osteophytes - none
|
28 participants
|
20 participants
|
|
Physical Examination
4 weeks : 3) Osteophytes - small
|
53 participants
|
58 participants
|
|
Physical Examination
4 weeks : 3) Osteophytes - multiple, moderate
|
20 participants
|
19 participants
|
|
Physical Examination
4 weeks : 4) Patellar Position - obvious baja
|
3 participants
|
0 participants
|
|
Physical Examination
4 weeks : 4) Patellar Position - normal
|
97 participants
|
99 participants
|
|
Physical Examination
4 weeks : 4) Patellar Position - obvious alta
|
1 participants
|
0 participants
|
|
Physical Examination
4 weeks : 7) Lachman's Test - mild
|
1 participants
|
1 participants
|
|
Physical Examination
4 weeks : 7) Lachman's Test - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
4 weeks : 8) Anterior Drawer Test - none
|
100 participants
|
97 participants
|
|
Physical Examination
4 weeks : 8) Anterior Drawer Test - mild
|
1 participants
|
2 participants
|
|
Physical Examination
4 weeks : 8) Anterior Drawer Test - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
4 weeks : 8) Anterior Drawer Test - severe
|
0 participants
|
0 participants
|
|
Physical Examination
4 weeks : 10) Valgus stress test 0 - none
|
100 participants
|
98 participants
|
|
Physical Examination
4 weeks : 10) Valgus stress test 0 - mild
|
1 participants
|
1 participants
|
|
Physical Examination
4 weeks : 10) Valgus stress test 0 - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
4 weeks : 10) Valgus stress test 0 - severe
|
0 participants
|
0 participants
|
|
Physical Examination
4 weeks : 11) Valgus stress test 30 - none
|
100 participants
|
98 participants
|
|
Physical Examination
4 weeks : 11) Valgus stress test 30 - mild
|
1 participants
|
1 participants
|
|
Physical Examination
4 weeks : 11) Valgus stress test 30 - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
4 weeks : 12) Varus stress test 0 - none
|
100 participants
|
98 participants
|
|
Physical Examination
4 weeks : 13) Varus stress test 30 - none
|
100 participants
|
98 participants
|
|
Physical Examination
4 weeks : 13) Varus stress test 30 - mild
|
1 participants
|
1 participants
|
|
Physical Examination
Baseline : 1) AP Alignmet - Valgus
|
35 participants
|
45 participants
|
|
Physical Examination
Baseline : 2) Joint Space Narrowing - mild
|
52 participants
|
56 participants
|
|
Physical Examination
Baseline : 3) Osteophytes - small
|
53 participants
|
58 participants
|
|
Physical Examination
Baseline : 4) Patellar Position - obvious baja
|
3 participants
|
0 participants
|
|
Physical Examination
Baseline : 5) Patellar Subluxation / Dislocation -dislocation
|
1 participants
|
0 participants
|
|
Physical Examination
Baseline : 6) Effusion - normal
|
64 participants
|
65 participants
|
|
Physical Examination
Baseline : 6) Effusion - nearly normal
|
36 participants
|
31 participants
|
|
Physical Examination
Baseline : 6) Effusion - severely abnormal
|
0 participants
|
0 participants
|
|
Physical Examination
Baseline : 7) Lachman's Test - none
|
101 participants
|
96 participants
|
|
Physical Examination
Baseline : 7) Lachman's Test - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
4 weeks : 15) PF crepitation - moderate
|
6 participants
|
6 participants
|
|
Physical Examination
4 weeks : 16) PF compression/grinding test - moderate
|
4 participants
|
3 participants
|
|
Physical Examination
4 weeks : 16) PF compression/grinding test - severe
|
0 participants
|
0 participants
|
|
Physical Examination
4 weeks : 17) Joint line tenderness_Med.ant - none
|
76 participants
|
70 participants
|
|
Physical Examination
4 weeks : 17) Joint line tenderness_Med.ant - mild
|
22 participants
|
29 participants
|
|
Physical Examination
4 weeks : 17) Joint line tenderness_Med.ant - moderate
|
3 participants
|
0 participants
|
|
Physical Examination
4 weeks : 17) Joint line tenderness_Med.ant - severe
|
0 participants
|
0 participants
|
|
Physical Examination
4 weeks : 18) Joint line tenderness_Med.mid - severe
|
0 participants
|
0 participants
|
|
Physical Examination
4 weeks : 19) Joint line tenderness_Med.post - moderate
|
5 participants
|
3 participants
|
|
Physical Examination
4 weeks : 19) Joint line tenderness_Med.post - severe
|
0 participants
|
0 participants
|
|
Physical Examination
4 weeks : 20) Joint line tenderness_Lat.ant - none
|
92 participants
|
94 participants
|
|
Physical Examination
4 weeks : 21) Joint line tenderness_Lat.mid - severe
|
0 participants
|
0 participants
|
|
Physical Examination
4 weeks : 22) Joint line tenderness_Lat.post - none
|
93 participants
|
94 participants
|
|
Physical Examination
4 weeks : 23) Medial compartment crepitation/pain - severe
|
0 participants
|
0 participants
|
|
Physical Examination
4 weeks : 24) Lateral compartment crepitation/pain - none
|
86 participants
|
89 participants
|
|
Physical Examination
4 weeks : 24) Lateral compartment crepitation/pain - mild
|
10 participants
|
6 participants
|
|
Physical Examination
4 weeks : 24) Lateral compartment crepitation/pain -moderate
|
5 participants
|
4 participants
|
|
Physical Examination
4 weeks : 24) Lateral compartment crepitation/pain - severe
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 1) AP Alignment - Varus
|
66 participants
|
54 participants
|
|
Physical Examination
12 weeks : 2) Joint Space Narrowing - mild
|
52 participants
|
56 participants
|
|
Physical Examination
12 weeks : 2) Joint Space Narrowing - moderate
|
29 participants
|
27 participants
|
|
Physical Examination
12 weeks : 2) Joint Space Narrowing - severe
|
4 participants
|
3 participants
|
|
Physical Examination
12 weeks : 3) Osteophytes - multiple, moderate
|
20 participants
|
19 participants
|
|
Physical Examination
12 weeks : 5) Patellar Subluxation / Dislocation - subluxable
|
11 participants
|
8 participants
|
|
Physical Examination
12 weeks : 5) Patellar Subluxation / Dislocation - subluxed
|
3 participants
|
2 participants
|
|
Physical Examination
12 weeks : 6) Effusion - abnormal
|
1 participants
|
0 participants
|
|
Physical Examination
12 weeks : 6) Effusion - severely abnormal
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 7) Lachman's Test - none
|
100 participants
|
98 participants
|
|
Physical Examination
12 weeks : 8) Anterior Drawer Test - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 8) Anterior Drawer Test - severe
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 9) Posterior Drawer Test - none
|
100 participants
|
99 participants
|
|
Physical Examination
12 weeks : 9) Posterior Drawer Test - mild
|
1 participants
|
0 participants
|
|
Physical Examination
12 weeks : 9) Posterior Drawer Test - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 9) Posterior Drawer Test - severe
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 10) Valgus stress test 0 - none
|
101 participants
|
99 participants
|
|
Physical Examination
12 weeks : 10) Valgus stress test 0 - mild
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 13) Varus stress test 30 - none
|
101 participants
|
99 participants
|
|
Physical Examination
12 weeks : 13) Varus stress test 30 - mild
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 14) Patellar tenderness - moderate
|
6 participants
|
3 participants
|
|
Physical Examination
12 weeks : 14) Patellar tenderness - severe
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 15) Patellofemoral (PF) crepitation - none
|
80 participants
|
79 participants
|
|
Physical Examination
12 weeks : 15) PF crepitation - mild
|
17 participants
|
15 participants
|
|
Physical Examination
12 weeks : 15) PF crepitation - moderate
|
4 participants
|
5 participants
|
|
Physical Examination
12 weeks : 17) Joint line tenderness_Med.ant - none
|
82 participants
|
80 participants
|
|
Physical Examination
12 weeks : 17) Joint line tenderness_Med.ant - mild
|
18 participants
|
19 participants
|
|
Physical Examination
12 weeks : 17) Joint line tenderness_Med.ant - moderate
|
1 participants
|
0 participants
|
|
Physical Examination
12 weeks : 17) Joint line tenderness_Med.ant - severe
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 18) Joint line tenderness_Med.mid - none
|
58 participants
|
53 participants
|
|
Physical Examination
12 weeks : 18) Joint line tenderness_Med.mid - mild
|
35 participants
|
39 participants
|
|
Physical Examination
4 weeks : 13) Varus stress test 30 - severe
|
0 participants
|
0 participants
|
|
Physical Examination
4 weeks : 14) Patellar tenderness - none
|
77 participants
|
79 participants
|
|
Physical Examination
4 weeks : 14) Patellar tenderness - mild
|
14 participants
|
17 participants
|
|
Physical Examination
4 weeks : 14) Patellar tenderness - moderate
|
10 participants
|
3 participants
|
|
Physical Examination
4 weeks : 15) PF crepitation - mild
|
19 participants
|
18 participants
|
|
Physical Examination
24 weeks : 6) Effusion - nearly normal
|
23 participants
|
17 participants
|
|
Physical Examination
24 weeks : 6) Effusion - abnormal
|
1 participants
|
0 participants
|
|
Physical Examination
24 weeks : 6) Effusion - severely abnormal
|
0 participants
|
0 participants
|
|
Physical Examination
24 weeks : 7) Lachman's Test - none
|
101 participants
|
99 participants
|
|
Physical Examination
24 weeks : 7) Lachman's Test - mild
|
0 participants
|
0 participants
|
|
Physical Examination
24 weeks : 7) Lachman's Test - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
24 weeks : 7) Lachman's Test - severe
|
0 participants
|
0 participants
|
|
Physical Examination
24 weeks : 8) Anterior Drawer Test - none
|
100 participants
|
98 participants
|
|
Physical Examination
24 weeks : 8) Anterior Drawer Test - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
24 weeks : 8) Anterior Drawer Test - severe
|
0 participants
|
0 participants
|
|
Physical Examination
24 weeks : 9) Posterior Drawer Test - none
|
100 participants
|
99 participants
|
|
Physical Examination
24 weeks : 9) Posterior Drawer Test - mild
|
1 participants
|
0 participants
|
|
Physical Examination
24 weeks : 9) Posterior Drawer Test - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
24 weeks : 9) Posterior Drawer Test - severe
|
0 participants
|
0 participants
|
|
Physical Examination
24 weeks : 10) Valgus stress test 0 - none
|
101 participants
|
99 participants
|
|
Physical Examination
24 weeks : 10) Valgus stress test 0 - mild
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 18) Joint line tenderness_Med.mid - moderate
|
8 participants
|
6 participants
|
|
Physical Examination
24 weeks : 10) Valgus stress test 0 - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 18) Joint line tenderness_Med.mid - severe
|
0 participants
|
1 participants
|
|
Physical Examination
12 weeks : 19) Joint line tenderness_Med.post - none
|
72 participants
|
74 participants
|
|
Physical Examination
12 weeks : 19) Joint line tenderness_Med.post - mild
|
25 participants
|
24 participants
|
|
Physical Examination
12 weeks : 19) Joint line tenderness_Med.post - moderate
|
4 participants
|
1 participants
|
|
Physical Examination
12 weeks : 19) Joint line tenderness_Med.post - severe
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 20) Joint line tenderness_Lat.ant - none
|
94 participants
|
93 participants
|
|
Physical Examination
12 weeks : 20) Joint line tenderness_Lat.ant - mild
|
7 participants
|
6 participants
|
|
Physical Examination
12 weeks : 20) Joint line tenderness_Lat.ant - severe
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 21) Joint line tenderness_Lat.mid - none
|
78 participants
|
81 participants
|
|
Physical Examination
12 weeks : 21) Joint line tenderness_Lat.mid - mild
|
23 participants
|
16 participants
|
|
Physical Examination
12 weeks : 21) Joint line tenderness_Lat.mid - moderate
|
0 participants
|
2 participants
|
|
Physical Examination
12 weeks : 21) Joint line tenderness_Lat.mid - severe
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 22) Joint line tenderness_Lat.post - none
|
95 participants
|
95 participants
|
|
Physical Examination
12 weeks : 22) Joint line tenderness_Lat.post - mild
|
5 participants
|
4 participants
|
|
Physical Examination
24 weeks : 10) Valgus stress test 0 - severe
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 22) Joint line tenderness_Lat.post - moderate
|
1 participants
|
0 participants
|
|
Physical Examination
24 weeks : 11) Valgus stress test 30 - none
|
101 participants
|
99 participants
|
|
Physical Examination
12 weeks : 22) Joint line tenderness_Lat.post - severe
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 23) Medial compartment crepitation/pain - none
|
96 participants
|
93 participants
|
|
Physical Examination
12 weeks : 23) Medial compartment crepitation/pain - mild
|
5 participants
|
6 participants
|
|
Physical Examination
12 weeks : 23) Medial compartment crepitation/pain - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 23) Medial compartment crepitation/pain - severe
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 24) Lateral compartment crepitation/pain - none
|
89 participants
|
94 participants
|
|
Physical Examination
12 weeks : 24) Lateral compartment crepitation/pain - mild
|
7 participants
|
3 participants
|
|
Physical Examination
12 weeks : 24) Lateral compartment crepitation/pain -moderate
|
5 participants
|
2 participants
|
|
Physical Examination
12 weeks : 24) Lateral compartment crepitation/pain - severe
|
0 participants
|
0 participants
|
|
Physical Examination
24 weeks : 1) AP Alignment - Varus
|
66 participants
|
54 participants
|
|
Physical Examination
24 weeks : 1) AP Alignmet - Valgus
|
35 participants
|
45 participants
|
|
Physical Examination
24 weeks : 2) Joint Space Narrowing - none
|
15 participants
|
13 participants
|
|
Physical Examination
24 weeks : 2) Joint Space Narrowing - mild
|
52 participants
|
56 participants
|
|
Physical Examination
24 weeks : 3) Osteophytes - multiple, large
|
0 participants
|
2 participants
|
|
Physical Examination
24 weeks : 4) Patellar Position - obvious baja
|
3 participants
|
0 participants
|
|
Physical Examination
24 weeks : 4) Patellar Position - normal
|
97 participants
|
99 participants
|
|
Physical Examination
24 weeks : 4) Patellar Position - obvious alta
|
1 participants
|
0 participants
|
|
Physical Examination
24 weeks : 11) Valgus stress test 30 - mild
|
0 participants
|
0 participants
|
|
Physical Examination
24 weeks : 5) Patellar Subluxation / Dislocation - centered
|
86 participants
|
89 participants
|
|
Physical Examination
24 weeks : 5) Patellar Subluxation / Dislocation - subluxable
|
11 participants
|
8 participants
|
|
Physical Examination
24 weeks : 5) Patellar Subluxation / Dislocation - subluxed
|
3 participants
|
2 participants
|
|
Physical Examination
24 weeks : 11) Valgus stress test 30 - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
24 weeks : 5) Patellar Subluxation / Dislocation -dislocation
|
1 participants
|
0 participants
|
|
Physical Examination
24 weeks : 6) Effusion - normal
|
77 participants
|
82 participants
|
|
Physical Examination
24 weeks : 15) PF crepitation - moderate
|
1 participants
|
1 participants
|
|
Physical Examination
24 weeks : 15) PF crepitation - severe
|
0 participants
|
0 participants
|
|
Physical Examination
24 weeks : 16) PF compression/grinding test - none
|
87 participants
|
97 participants
|
|
Physical Examination
24 weeks : 16) PF compression/grinding test - mild
|
11 participants
|
1 participants
|
|
Physical Examination
24 weeks : 16) PF compression/grinding test - moderate
|
3 participants
|
1 participants
|
|
Physical Examination
24 weeks : 16) PF compression/grinding test - severe
|
0 participants
|
0 participants
|
|
Physical Examination
24 weeks : 17) Joint line tenderness_Med.ant - none
|
89 participants
|
82 participants
|
|
Physical Examination
24 weeks : 17) Joint line tenderness_Med.ant - mild
|
9 participants
|
16 participants
|
|
Physical Examination
24 weeks : 17) Joint line tenderness_Med.ant - moderate
|
3 participants
|
1 participants
|
|
Physical Examination
24 weeks : 17) Joint line tenderness_Med.ant - severe
|
0 participants
|
0 participants
|
|
Physical Examination
24 weeks : 18) Joint line tenderness_Med.mid - none
|
65 participants
|
57 participants
|
|
Physical Examination
24 weeks : 18) Joint line tenderness_Med.mid - mild
|
27 participants
|
35 participants
|
|
Physical Examination
24 weeks : 18) Joint line tenderness_Med.mid - moderate
|
9 participants
|
6 participants
|
|
Physical Examination
24 weeks : 18) Joint line tenderness_Med.mid - severe
|
0 participants
|
1 participants
|
|
Physical Examination
24 weeks : 19) Joint line tenderness_Med.post - none
|
79 participants
|
81 participants
|
|
Physical Examination
24 weeks : 19) Joint line tenderness_Med.post - mild
|
19 participants
|
16 participants
|
|
Physical Examination
24 weeks : 19) Joint line tenderness_Med.post - moderate
|
3 participants
|
2 participants
|
|
Physical Examination
24 weeks : 19) Joint line tenderness_Med.post - severe
|
0 participants
|
0 participants
|
|
Physical Examination
24 weeks : 20) Joint line tenderness_Lat.ant - severe
|
0 participants
|
0 participants
|
|
Physical Examination
24 weeks : 21) Joint line tenderness_Lat.mid - none
|
85 participants
|
86 participants
|
|
Physical Examination
24 weeks : 21) Joint line tenderness_Lat.mid - mild
|
16 participants
|
13 participants
|
|
Physical Examination
24 weeks : 21) Joint line tenderness_Lat.mid - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
24 weeks : 21) Joint line tenderness_Lat.mid - severe
|
0 participants
|
0 participants
|
|
Physical Examination
24 weeks : 22) Joint line tenderness_Lat.post - none
|
98 participants
|
98 participants
|
|
Physical Examination
24 weeks : 22) Joint line tenderness_Lat.post - mild
|
3 participants
|
1 participants
|
|
Physical Examination
24 weeks : 22) Joint line tenderness_Lat.post - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
24 weeks : 22) Joint line tenderness_Lat.post - severe
|
0 participants
|
0 participants
|
|
Physical Examination
24 weeks : 23) Medial compartment crepitation/pain - none
|
97 participants
|
96 participants
|
|
Physical Examination
24 weeks : 23) Medial compartment crepitation/pain - mild
|
4 participants
|
3 participants
|
|
Physical Examination
24 weeks : 23) Medial compartment crepitation/pain - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
24 weeks : 11) Valgus stress test 30 - severe
|
0 participants
|
0 participants
|
|
Physical Examination
24 weeks : 12) Varus stress test 0 - none
|
101 participants
|
99 participants
|
|
Physical Examination
24 weeks : 12) Varus stress test 0 - mild
|
0 participants
|
0 participants
|
|
Physical Examination
24 weeks : 12) Varus stress test 0 - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
24 weeks : 12) Varus stress test 0 - severe
|
0 participants
|
0 participants
|
|
Physical Examination
24 weeks : 13) Varus stress test 30 - none
|
101 participants
|
99 participants
|
|
Physical Examination
24 weeks : 13) Varus stress test 30 - mild
|
0 participants
|
0 participants
|
|
Physical Examination
24 weeks : 13) Varus stress test 30 - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
24 weeks : 13) Varus stress test 30 - severe
|
0 participants
|
0 participants
|
|
Physical Examination
24 weeks : 14) Patellar tenderness - none
|
82 participants
|
81 participants
|
|
Physical Examination
24 weeks : 14) Patellar tenderness - mild
|
16 participants
|
17 participants
|
|
Physical Examination
24 weeks : 14) Patellar tenderness - moderate
|
3 participants
|
1 participants
|
|
Physical Examination
24 weeks : 14) Patellar tenderness - severe
|
0 participants
|
0 participants
|
|
Physical Examination
24 weeks : 15) Patellofemoral (PF) crepitation - none
|
82 participants
|
80 participants
|
|
Physical Examination
Baseline : 14) Patellar tenderness - none
|
66 participants
|
71 participants
|
|
Physical Examination
Baseline : 14) Patellar tenderness - mild
|
23 participants
|
19 participants
|
|
Physical Examination
Baseline : 14) Patellar tenderness - moderate
|
12 participants
|
9 participants
|
|
Physical Examination
Baseline : 14) Patellar tenderness - severe
|
0 participants
|
0 participants
|
|
Physical Examination
Baseline : 15) Patellofemoral (PF) crepitation - none
|
64 participants
|
64 participants
|
|
Physical Examination
Baseline : 15) PF crepitation - mild
|
28 participants
|
27 participants
|
|
Physical Examination
Baseline : 8) Anterior Drawer Test - none
|
97 participants
|
95 participants
|
|
Physical Examination
Baseline : 15) PF crepitation - moderate
|
9 participants
|
8 participants
|
|
Physical Examination
Baseline : 15) PF crepitation - severe
|
0 participants
|
0 participants
|
|
Physical Examination
Baseline : 8) Anterior Drawer Test - mild
|
4 participants
|
3 participants
|
|
Physical Examination
Baseline : 8) Anterior Drawer Test - moderate
|
0 participants
|
1 participants
|
|
Physical Examination
Baseline : 8) Anterior Drawer Test - severe
|
0 participants
|
0 participants
|
|
Physical Examination
Baseline : 9) Posterior Drawer Test - none
|
100 participants
|
99 participants
|
|
Physical Examination
Baseline : 9) Posterior Drawer Test - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
Baseline : 16) PF compression/grinding test - mild
|
23 participants
|
15 participants
|
|
Physical Examination
24 weeks : 23) Medial compartment crepitation/pain - severe
|
0 participants
|
0 participants
|
|
Physical Examination
24 weeks : 24) Lateral compartment crepitation/pain - none
|
93 participants
|
96 participants
|
|
Physical Examination
24 weeks : 24) Lateral compartment crepitation/pain - mild
|
5 participants
|
3 participants
|
|
Physical Examination
24 weeks : 24) Lateral compartment crepitation/pain -moderate
|
3 participants
|
0 participants
|
|
Physical Examination
24 weeks : 24) Lateral compartment crepitation/pain - severe
|
0 participants
|
0 participants
|
|
Physical Examination
Baseline : 16) PF compression/grinding test - moderate
|
7 participants
|
8 participants
|
|
Physical Examination
Baseline : 1) AP Alignment - Varus
|
66 participants
|
54 participants
|
|
Physical Examination
Baseline : 2) Joint Space Narrowing - none
|
15 participants
|
13 participants
|
|
Physical Examination
Baseline : 2) Joint Space Narrowing - moderate
|
29 participants
|
27 participants
|
|
Physical Examination
Baseline : 2) Joint Space Narrowing - severe
|
4 participants
|
3 participants
|
|
Physical Examination
Baseline : 3) Osteophytes - none
|
28 participants
|
20 participants
|
|
Physical Examination
Baseline : 3) Osteophytes - multiple, moderate
|
20 participants
|
19 participants
|
|
Physical Examination
Baseline : 3) Osteophytes - multiple, large
|
0 participants
|
2 participants
|
|
Physical Examination
Baseline : 4) Patellar Position - normal
|
97 participants
|
99 participants
|
|
Physical Examination
Baseline : 4) Patellar Position - obvious alta
|
1 participants
|
0 participants
|
|
Physical Examination
Baseline : 5) Patellar Subluxation / Dislocation - centered
|
86 participants
|
89 participants
|
|
Physical Examination
Baseline : 5) Patellar Subluxation / Dislocation - subluxable
|
11 participants
|
8 participants
|
|
Physical Examination
Baseline : 5) Patellar Subluxation / Dislocation - subluxed
|
3 participants
|
2 participants
|
|
Physical Examination
Baseline : 6) Effusion - abnormal
|
1 participants
|
3 participants
|
|
Physical Examination
Baseline : 7) Lachman's Test - mild
|
0 participants
|
3 participants
|
|
Physical Examination
Baseline : 18) Joint line tenderness_Med.mid - mild
|
37 participants
|
39 participants
|
|
Physical Examination
4 weeks : 2) Joint Space Narrowing - moderate
|
29 participants
|
27 participants
|
|
Physical Examination
Baseline : 19) Joint line tenderness_Med.post - mild
|
27 participants
|
25 participants
|
|
Physical Examination
Baseline : 19) Joint line tenderness_Med.post - moderate
|
15 participants
|
9 participants
|
|
Physical Examination
4 weeks : 3) Osteophytes - multiple, large
|
0 participants
|
2 participants
|
|
Physical Examination
4 weeks : 5) Patellar Subluxation / Dislocation - centered
|
86 participants
|
89 participants
|
|
Physical Examination
4 weeks : 5) Patellar Subluxation / Dislocation - subluxable
|
11 participants
|
8 participants
|
|
Physical Examination
4 weeks : 5) Patellar Subluxation / Dislocation - subluxed
|
3 participants
|
2 participants
|
|
Physical Examination
Baseline : 16) PF compression/grinding test - severe
|
0 participants
|
0 participants
|
|
Physical Examination
Baseline : 17) Joint line tenderness_Med.ant - none
|
67 participants
|
58 participants
|
|
Physical Examination
Baseline : 17) Joint line tenderness_Med.ant - moderate
|
8 participants
|
5 participants
|
|
Physical Examination
Baseline : 12) Varus stress test 0 - none
|
99 participants
|
98 participants
|
|
Physical Examination
Baseline : 12) Varus stress test 0 - mild
|
2 participants
|
1 participants
|
|
Physical Examination
Baseline : 12) Varus stress test 0 - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
Baseline : 12) Varus stress test 0 - severe
|
0 participants
|
0 participants
|
|
Physical Examination
Baseline : 13) Varus stress test 30 - mild
|
1 participants
|
1 participants
|
|
Physical Examination
4 weeks : 20) Joint line tenderness_Lat.ant - mild
|
9 participants
|
5 participants
|
|
Physical Examination
4 weeks : 20) Joint line tenderness_Lat.ant - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
4 weeks : 20) Joint line tenderness_Lat.ant - severe
|
0 participants
|
0 participants
|
|
Physical Examination
4 weeks : 21) Joint line tenderness_Lat.mid - none
|
75 participants
|
81 participants
|
|
Physical Examination
4 weeks : 21) Joint line tenderness_Lat.mid - mild
|
24 participants
|
15 participants
|
|
Physical Examination
4 weeks : 21) Joint line tenderness_Lat.mid - moderate
|
2 participants
|
3 participants
|
|
Physical Examination
12 weeks : 10) Valgus stress test 0 - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 10) Valgus stress test 0 - severe
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 11) Valgus stress test 30 - none
|
101 participants
|
99 participants
|
|
Physical Examination
12 weeks : 11) Valgus stress test 30 - mild
|
0 participants
|
0 participants
|
|
Physical Examination
4 weeks : 22) Joint line tenderness_Lat.post - mild
|
8 participants
|
3 participants
|
|
Physical Examination
4 weeks : 22) Joint line tenderness_Lat.post - moderate
|
0 participants
|
2 participants
|
|
Physical Examination
4 weeks : 22) Joint line tenderness_Lat.post - severe
|
0 participants
|
0 participants
|
|
Physical Examination
4 weeks : 23) Medial compartment crepitation/pain - none
|
90 participants
|
86 participants
|
|
Physical Examination
12 weeks : 15) PF crepitation - severe
|
0 participants
|
0 participants
|
|
Physical Examination
4 weeks : 23) Medial compartment crepitation/pain - mild
|
11 participants
|
10 participants
|
|
Physical Examination
4 weeks : 23) Medial compartment crepitation/pain - moderate
|
0 participants
|
3 participants
|
|
Physical Examination
12 weeks : 11) Valgus stress test 30 - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 11) Valgus stress test 30 - severe
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 12) Varus stress test 0 - none
|
101 participants
|
99 participants
|
|
Physical Examination
12 weeks : 12) Varus stress test 0 - mild
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 12) Varus stress test 0 - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 12) Varus stress test 0 - severe
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 13) Varus stress test 30 - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 13) Varus stress test 30 - severe
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 14) Patellar tenderness - none
|
78 participants
|
78 participants
|
|
Physical Examination
12 weeks : 14) Patellar tenderness - mild
|
17 participants
|
18 participants
|
|
Physical Examination
4 weeks : 5) Patellar Subluxation / Dislocation -dislocation
|
1 participants
|
0 participants
|
|
Physical Examination
4 weeks : 6) Effusion - normal
|
74 participants
|
82 participants
|
|
Physical Examination
4 weeks : 6) Effusion - nearly normal
|
26 participants
|
17 participants
|
|
Physical Examination
Baseline : 20) Joint line tenderness_Lat.ant - none
|
80 participants
|
81 participants
|
|
Physical Examination
4 weeks : 6) Effusion - abnormal
|
1 participants
|
0 participants
|
|
Physical Examination
4 weeks : 6) Effusion - severely abnormal
|
0 participants
|
0 participants
|
|
Physical Examination
4 weeks : 7) Lachman's Test - none
|
100 participants
|
98 participants
|
|
Physical Examination
4 weeks : 7) Lachman's Test - severe
|
0 participants
|
0 participants
|
|
Physical Examination
Baseline : 21) Joint line tenderness_Lat.mid - none
|
71 participants
|
73 participants
|
|
Physical Examination
4 weeks : 9) Posterior Drawer Test - none
|
101 participants
|
99 participants
|
|
Physical Examination
4 weeks : 9) Posterior Drawer Test - mild
|
0 participants
|
0 participants
|
|
Physical Examination
4 weeks : 9) Posterior Drawer Test - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
4 weeks : 9) Posterior Drawer Test - severe
|
0 participants
|
0 participants
|
|
Physical Examination
Baseline : 21) Joint line tenderness_Lat.mid - mild
|
21 participants
|
16 participants
|
|
Physical Examination
Baseline : 21) Joint line tenderness_Lat.mid - moderate
|
6 participants
|
8 participants
|
|
Physical Examination
Baseline : 21) Joint line tenderness_Lat.mid - severe
|
3 participants
|
2 participants
|
|
Physical Examination
Baseline : 22) Joint line tenderness_Lat.post - none
|
90 participants
|
84 participants
|
|
Physical Examination
4 weeks : 11) Valgus stress test 30 - severe
|
0 participants
|
0 participants
|
|
Physical Examination
4 weeks : 12) Varus stress test 0 - mild
|
1 participants
|
1 participants
|
|
Physical Examination
4 weeks : 12) Varus stress test 0 - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
4 weeks : 12) Varus stress test 0 - severe
|
0 participants
|
0 participants
|
|
Physical Examination
Baseline : 22) Joint line tenderness_Lat.post - moderate
|
5 participants
|
5 participants
|
|
Physical Examination
12 weeks : 1) AP Alignmet - Valgus
|
35 participants
|
45 participants
|
|
Physical Examination
12 weeks : 2) Joint Space Narrowing - none
|
15 participants
|
13 participants
|
|
Physical Examination
12 weeks : 3) Osteophytes - none
|
28 participants
|
20 participants
|
|
Physical Examination
12 weeks : 3) Osteophytes - small
|
53 participants
|
58 participants
|
|
Physical Examination
12 weeks : 3) Osteophytes - multiple, large
|
0 participants
|
2 participants
|
|
Physical Examination
12 weeks : 4) Patellar Position - obvious baja
|
3 participants
|
0 participants
|
|
Physical Examination
4 weeks : 14) Patellar tenderness - severe
|
0 participants
|
0 participants
|
|
Physical Examination
4 weeks : 15) Patellofemoral (PF) crepitation - none
|
76 participants
|
74 participants
|
|
Physical Examination
4 weeks : 15) PF crepitation - severe
|
0 participants
|
1 participants
|
|
Physical Examination
4 weeks : 16) PF compression/grinding test - none
|
80 participants
|
87 participants
|
|
Physical Examination
4 weeks : 16) PF compression/grinding test - mild
|
17 participants
|
9 participants
|
|
Physical Examination
12 weeks : 4) Patellar Position - normal
|
97 participants
|
99 participants
|
|
Physical Examination
12 weeks : 4) Patellar Position - obvious alta
|
1 participants
|
0 participants
|
|
Physical Examination
12 weeks : 5) Patellar Subluxation / Dislocation - centered
|
86 participants
|
89 participants
|
|
Physical Examination
12 weeks : 5) Patellar Subluxation / Dislocation -dislocation
|
1 participants
|
0 participants
|
|
Physical Examination
12 weeks : 6) Effusion - normal
|
76 participants
|
82 participants
|
|
Physical Examination
12 weeks : 6) Effusion - nearly normal
|
24 participants
|
17 participants
|
|
Physical Examination
12 weeks : 7) Lachman's Test - mild
|
1 participants
|
1 participants
|
|
Physical Examination
12 weeks : 7) Lachman's Test - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 7) Lachman's Test - severe
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 8) Anterior Drawer Test - none
|
99 participants
|
98 participants
|
|
Physical Examination
12 weeks : 8) Anterior Drawer Test - mild
|
2 participants
|
1 participants
|
|
Physical Examination
4 weeks : 18) Joint line tenderness_Med.mid - none
|
42 participants
|
44 participants
|
|
Physical Examination
4 weeks : 18) Joint line tenderness_Med.mid - mild
|
51 participants
|
47 participants
|
|
Physical Examination
4 weeks : 18) Joint line tenderness_Med.mid - moderate
|
8 participants
|
8 participants
|
|
Physical Examination
4 weeks : 19) Joint line tenderness_Med.post - none
|
68 participants
|
71 participants
|
|
Physical Examination
4 weeks : 19) Joint line tenderness_Med.post - mild
|
28 participants
|
25 participants
|
|
Physical Examination
24 weeks : 2) Joint Space Narrowing - moderate
|
29 participants
|
27 participants
|
|
Physical Examination
24 weeks : 2) Joint Space Narrowing - severe
|
4 participants
|
3 participants
|
|
Physical Examination
24 weeks : 3) Osteophytes - none
|
28 participants
|
20 participants
|
|
Physical Examination
24 weeks : 3) Osteophytes - small
|
53 participants
|
58 participants
|
|
Physical Examination
24 weeks : 3) Osteophytes - multiple, moderate
|
20 participants
|
19 participants
|
|
Physical Examination
24 weeks : 8) Anterior Drawer Test - mild
|
1 participants
|
1 participants
|
|
Physical Examination
24 weeks : 15) PF crepitation - mild
|
18 participants
|
18 participants
|
|
Physical Examination
24 weeks : 20) Joint line tenderness_Lat.ant - none
|
97 participants
|
95 participants
|
|
Physical Examination
24 weeks : 20) Joint line tenderness_Lat.ant - mild
|
4 participants
|
4 participants
|
|
Physical Examination
24 weeks : 20) Joint line tenderness_Lat.ant - moderate
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 16) PF compression/grinding test - none
|
84 participants
|
91 participants
|
|
Physical Examination
12 weeks : 16) PF compression/grinding test - mild
|
14 participants
|
6 participants
|
|
Physical Examination
12 weeks : 16) PF compression/grinding test - moderate
|
3 participants
|
2 participants
|
|
Physical Examination
12 weeks : 16) PF compression/grinding test - severe
|
0 participants
|
0 participants
|
|
Physical Examination
12 weeks : 20) Joint line tenderness_Lat.ant - moderate
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: at the screening visit, 4 and 12 weeks after injection100 mm Visual Analogue Score (VAS) is measurement instrument for subjective characteristics or attitudes that cannot be directly measured. In this trial, it is used for quantification of the pain on the defected knee. The VAS score of the investigational group and the control group at baseline, 4 weeks and 12 weeks after injection will be compared and analyzed. Score range: 0 \~ 100 mm Higher score indicates the worse outcome. In this case, participant is feeling more pain.
Outcome measures
| Measure |
CartiZol, Collagen Injection
n=101 Participants
Their eligibility to participate in the study is checked, and they are randomized into the intra-articular collagen injection group based on a randomization table.
CartiZol: The product, CartiZol, which contains absorbable collagen, is applied on the cartilage defect to stimulate the neovasculization and cell penetration and to assist the natural wound healing process. It supplements the defective or damaged cartilage. Place the needle on the tip of the syringe and inject the product into the articular cavity.
|
Normal Saline Injection
n=99 Participants
Their eligibility to participate in the study is checked, and they are randomized into the (placebo) injection group based on a randomization table.
Normal saline: 1) Supplementation of fluid and electrolytes (sodium or chlorine deficiency) 2) Diluent for injection solution Place the needle on the tip of the syringe and inject the product into the articular cavity.
|
|---|---|---|
|
100 mm VAS
baseline
|
60.51 score on a scale
Standard Deviation 13.82
|
62.05 score on a scale
Standard Deviation 12.68
|
|
100 mm VAS
4 weeks
|
44.34 score on a scale
Standard Deviation 20.03
|
46.90 score on a scale
Standard Deviation 21.07
|
|
100 mm VAS
12 weeks
|
37.01 score on a scale
Standard Deviation 23.98
|
43.55 score on a scale
Standard Deviation 23.57
|
Adverse Events
CartiZol, Collagen Injection
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Normal Saline Injection
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CartiZol, Collagen Injection
n=101 participants at risk
Their eligibility to participate in the study is checked, and they are randomized into the intra-articular collagen injection group based on a randomization table.
CartiZol: The product, CartiZol, which contains absorbable collagen, is applied on the cartilage defect to stimulate the neovasculization and cell penetration and to assist the natural wound healing process. It supplements the defective or damaged cartilage. Place the needle on the tip of the syringe and inject the product into the articular cavity.
|
Normal Saline Injection
n=99 participants at risk
Their eligibility to participate in the study is checked, and they are randomized into the (placebo) injection group based on a randomization table.
Normal saline: 1) Supplementation of fluid and electrolytes (sodium or chlorine deficiency) 2) Diluent for injection solution Place the needle on the tip of the syringe and inject the product into the articular cavity.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Herniated nucleus pulposus
|
0.99%
1/101
|
0.00%
0/99
|
|
Nervous system disorders
Spinal nerve plexus root
|
0.99%
1/101
|
0.00%
0/99
|
|
Eye disorders
Cataract
|
0.99%
1/101
|
0.00%
0/99
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rt. submandibular mass
|
0.99%
1/101
|
0.00%
0/99
|
|
Vascular disorders
Lt. subclavian artery stenosis
|
0.99%
1/101
|
0.00%
0/99
|
|
Ear and labyrinth disorders
Rt. otorrhea
|
0.00%
0/101
|
1.0%
1/99
|
Other adverse events
| Measure |
CartiZol, Collagen Injection
n=101 participants at risk
Their eligibility to participate in the study is checked, and they are randomized into the intra-articular collagen injection group based on a randomization table.
CartiZol: The product, CartiZol, which contains absorbable collagen, is applied on the cartilage defect to stimulate the neovasculization and cell penetration and to assist the natural wound healing process. It supplements the defective or damaged cartilage. Place the needle on the tip of the syringe and inject the product into the articular cavity.
|
Normal Saline Injection
n=99 participants at risk
Their eligibility to participate in the study is checked, and they are randomized into the (placebo) injection group based on a randomization table.
Normal saline: 1) Supplementation of fluid and electrolytes (sodium or chlorine deficiency) 2) Diluent for injection solution Place the needle on the tip of the syringe and inject the product into the articular cavity.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
5.9%
6/101
|
6.1%
6/99
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place