Trial Outcomes & Findings for ShapeMatch Cutting Guide Functional Outcomes Study (NCT NCT02539992)
NCT ID: NCT02539992
Last Updated: 2024-02-22
Results Overview
To demonstrate by means of fluoroscopy that TKR's performed using a kinematic aligned ShapeMatch Cutting Guide provides better short term kinematic and functional performance compared to those TKR's performed with ShapeMatch cutting guides modified to provide neutral overall limb alignment or with conventional instrumentation intended to achieve neutral overall limb alignment.
TERMINATED
NA
44 participants
6 months
2024-02-22
Participant Flow
56 patients have been screened for study participation. No patient withdrew his/her informed consent.
12/56 patients received another procedure. Therefore 44 patients were enrolled in 4 centers.
Participant milestones
| Measure |
Triathlon® CR/Kinematic Alignment
Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.
Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides
|
Triathlon® CR/Neutral Overall Limb Alignment
Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.
Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides
|
Triathlon® CR/Conventional Limb Alignment
Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.
Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
11
|
18
|
|
Overall Study
COMPLETED
|
15
|
7
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ShapeMatch Cutting Guide Functional Outcomes Study
Baseline characteristics by cohort
| Measure |
Triathlon® CR/Kinematic Alignment
n=15 Participants
Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.
Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides
|
Triathlon® CR/Neutral Overall Limb Alignment
n=11 Participants
Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.
Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides
|
Triathlon® CR/Conventional Limb Alignment
n=18 Participants
Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.
Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
69 years
STANDARD_DEVIATION 5.8 • n=99 Participants
|
67 years
STANDARD_DEVIATION 9.3 • n=107 Participants
|
70 years
STANDARD_DEVIATION 4.8 • n=206 Participants
|
69 years
STANDARD_DEVIATION 6.4 • n=7 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Region of Enrollment
Italy
|
11 participants
n=99 Participants
|
7 participants
n=107 Participants
|
12 participants
n=206 Participants
|
30 participants
n=7 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
6 participants
n=7 Participants
|
|
Region of Enrollment
Germany
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
2 participants
n=206 Participants
|
8 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Early study termination resulted in limited availability of data for analysis to provide robust, meaningful results. Therefore the fluoroscopic data sets of the Neutral Overall Limb Alignment and Conventional Limb Alignment groups were combined and compared with the Kinematic Alignment group.
To demonstrate by means of fluoroscopy that TKR's performed using a kinematic aligned ShapeMatch Cutting Guide provides better short term kinematic and functional performance compared to those TKR's performed with ShapeMatch cutting guides modified to provide neutral overall limb alignment or with conventional instrumentation intended to achieve neutral overall limb alignment.
Outcome measures
| Measure |
Triathlon® CR/Kinematic Alignment
n=6 Participants
Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.
Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides
|
Triathlon® CR/Neutral Overall Limb Alignment
n=11 Participants
Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.
Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides
|
Triathlon® CR/Conventional Limb Alignment
Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.
Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation
|
|---|---|---|---|
|
Assessment of Better Functional Performance of Total Knee Replacement (TKR) Using a Kinematic Aligned ShapeMatch Cutting Guide by Means of Fluoroscopy.
Contact Point Rotation (CPR) Stair Climbing
|
7.3 Degrees
Standard Deviation 3.5
|
8.2 Degrees
Standard Deviation 3.2
|
—
|
|
Assessment of Better Functional Performance of Total Knee Replacement (TKR) Using a Kinematic Aligned ShapeMatch Cutting Guide by Means of Fluoroscopy.
CPR Chair Rising
|
12.6 Degrees
Standard Deviation 2.6
|
10.2 Degrees
Standard Deviation 3.7
|
—
|
|
Assessment of Better Functional Performance of Total Knee Replacement (TKR) Using a Kinematic Aligned ShapeMatch Cutting Guide by Means of Fluoroscopy.
CPR Extension-Against-Gravity
|
12.5 Degrees
Standard Deviation 4.2
|
8.8 Degrees
Standard Deviation 5.3
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.
Get-up-and-go test uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. One source suggests that scores of ten seconds or less indicate normal mobility, 11 - 20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls.
Outcome measures
| Measure |
Triathlon® CR/Kinematic Alignment
n=15 Participants
Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.
Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides
|
Triathlon® CR/Neutral Overall Limb Alignment
n=7 Participants
Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.
Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides
|
Triathlon® CR/Conventional Limb Alignment
n=14 Participants
Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.
Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation
|
|---|---|---|---|
|
Investigation of Clinical Performance and Patient Outcome With the Get-up and go Test
|
5 seconds
Standard Deviation 2.9
|
6 seconds
Standard Deviation 2.8
|
7 seconds
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 1 year follow-upPopulation: Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.
KOOS consists of 5 subscales: Pain, other symptoms, function in daily living , function in sport and recreation and knee related quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).
Outcome measures
| Measure |
Triathlon® CR/Kinematic Alignment
n=7 Participants
Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.
Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides
|
Triathlon® CR/Neutral Overall Limb Alignment
n=15 Participants
Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.
Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides
|
Triathlon® CR/Conventional Limb Alignment
n=14 Participants
Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.
Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation
|
|---|---|---|---|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
Symptoms
|
75 units on a scale
Standard Deviation 20.0
|
84 units on a scale
Standard Deviation 11.6
|
82 units on a scale
Standard Deviation 11.7
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
Pain
|
88 units on a scale
Standard Deviation 13.7
|
91 units on a scale
Standard Deviation 12.7
|
87 units on a scale
Standard Deviation 15.2
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
Daily Living Activities
|
89 units on a scale
Standard Deviation 10.6
|
92 units on a scale
Standard Deviation 8.9
|
86 units on a scale
Standard Deviation 13.4
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
Sport/Recreation
|
47 units on a scale
Standard Deviation 25.1
|
58 units on a scale
Standard Deviation 28.3
|
64 units on a scale
Standard Deviation 27.3
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
Quality of Life
|
89 units on a scale
Standard Deviation 13.8
|
82 units on a scale
Standard Deviation 19.9
|
76 units on a scale
Standard Deviation 21.6
|
SECONDARY outcome
Timeframe: 1 year follow-upPopulation: Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.
The FJS consists of 12 questions and focuses on the patients' awareness of their joint replacement during a range of day to day and recreational activities. The score has a range of 0-100. High scores indicate good outcome, i.e., a high degree of being able to forget about the affected joint in daily life.
Outcome measures
| Measure |
Triathlon® CR/Kinematic Alignment
n=15 Participants
Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.
Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides
|
Triathlon® CR/Neutral Overall Limb Alignment
n=7 Participants
Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.
Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides
|
Triathlon® CR/Conventional Limb Alignment
n=14 Participants
Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.
Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation
|
|---|---|---|---|
|
Investigation of Clinical Performance and Patient Outcome With the Forgotten Joint Score (FJS) Patient Questionnaire.
|
66 units on a scale
Standard Deviation 32.1
|
82 units on a scale
Standard Deviation 15.6
|
69 units on a scale
Standard Deviation 27.7
|
SECONDARY outcome
Timeframe: 1 year follow-upPopulation: Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.
The EQ-5D index has an upper bound equal to 1 that indicates full health (indicated by "no problem" in all domains), whereas 0 represents death. Negative values are allowed, and the lower bound varies depending on country-specific value set used. UK time Trade Off (UKTTO) indicates the patient status compared to the normal state of the UK population.
Outcome measures
| Measure |
Triathlon® CR/Kinematic Alignment
n=15 Participants
Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.
Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides
|
Triathlon® CR/Neutral Overall Limb Alignment
n=7 Participants
Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.
Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides
|
Triathlon® CR/Conventional Limb Alignment
n=14 Participants
Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.
Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation
|
|---|---|---|---|
|
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).
|
0.9 units on a scale
Standard Deviation 0.14
|
0.8 units on a scale
Standard Deviation 0.12
|
0.9 units on a scale
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: 1 year follow-upPopulation: Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.
The SF-36 Health Survey is a 36-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
Outcome measures
| Measure |
Triathlon® CR/Kinematic Alignment
n=15 Participants
Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.
Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides
|
Triathlon® CR/Neutral Overall Limb Alignment
n=7 Participants
Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.
Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides
|
Triathlon® CR/Conventional Limb Alignment
n=14 Participants
Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.
Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation
|
|---|---|---|---|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36).
Physikal Function
|
51 units on a scale
Standard Deviation 4.4
|
47 units on a scale
Standard Deviation 6.3
|
48 units on a scale
Standard Deviation 6.4
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36).
Role Physical
|
50 units on a scale
Standard Deviation 7.0
|
48 units on a scale
Standard Deviation 11.3
|
48 units on a scale
Standard Deviation 7.9
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36).
Bodily Pain
|
54 units on a scale
Standard Deviation 9.5
|
46 units on a scale
Standard Deviation 11.5
|
49 units on a scale
Standard Deviation 8.1
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36).
General Health
|
51 units on a scale
Standard Deviation 6.7
|
50 units on a scale
Standard Deviation 6.1
|
54 units on a scale
Standard Deviation 7.4
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36).
Vitality
|
57 units on a scale
Standard Deviation 9.3
|
54 units on a scale
Standard Deviation 7.8
|
57 units on a scale
Standard Deviation 9.1
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36).
Social Functioning
|
50 units on a scale
Standard Deviation 10.0
|
52 units on a scale
Standard Deviation 7.9
|
53 units on a scale
Standard Deviation 5.7
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36).
Role Emotional
|
50 units on a scale
Standard Deviation 6.5
|
45 units on a scale
Standard Deviation 6.6
|
49 units on a scale
Standard Deviation 10.2
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36).
Mental Health
|
53 units on a scale
Standard Deviation 7.0
|
50 units on a scale
Standard Deviation 9.4
|
51 units on a scale
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: 1 year follow-upPopulation: Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.
The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, Range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.
Outcome measures
| Measure |
Triathlon® CR/Kinematic Alignment
n=15 Participants
Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.
Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides
|
Triathlon® CR/Neutral Overall Limb Alignment
n=7 Participants
Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.
Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides
|
Triathlon® CR/Conventional Limb Alignment
n=14 Participants
Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.
Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation
|
|---|---|---|---|
|
Assessment of Better Performance of TKR Using a Kinematic Aligned ShapeMatch Cutting Guide by Functional Evaluation With Knee Society Score (KSS).
Assessment Score
|
87 units on a scale
Standard Deviation 11.2
|
84 units on a scale
Standard Deviation 16.1
|
82 units on a scale
Standard Deviation 8.9
|
|
Assessment of Better Performance of TKR Using a Kinematic Aligned ShapeMatch Cutting Guide by Functional Evaluation With Knee Society Score (KSS).
Function Score
|
91 units on a scale
Standard Deviation 17.7
|
89 units on a scale
Standard Deviation 14.6
|
97 units on a scale
Standard Deviation 4.7
|
Adverse Events
Triathlon® CR/Kinematic Alignment
Triathlon® CR/Neutral Overall Limb Alignment
Triathlon® CR/Conventional Limb Alignment
Serious adverse events
| Measure |
Triathlon® CR/Kinematic Alignment
n=15 participants at risk
Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.
Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides
|
Triathlon® CR/Neutral Overall Limb Alignment
n=11 participants at risk
Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.
Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides
|
Triathlon® CR/Conventional Limb Alignment
n=18 participants at risk
Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.
Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Flexion deficit
|
0.00%
0/15
|
0.00%
0/11
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Instability
|
0.00%
0/15
|
18.2%
2/11 • Number of events 2
|
0.00%
0/18
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/15
|
9.1%
1/11 • Number of events 1
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
6.7%
1/15 • Number of events 1
|
0.00%
0/11
|
0.00%
0/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mammary Carcinoma
|
0.00%
0/15
|
9.1%
1/11 • Number of events 1
|
0.00%
0/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic cancer
|
0.00%
0/15
|
0.00%
0/11
|
5.6%
1/18 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Eric Garling, Director Medical & Scientific Affairs Europe
Stryker European Operations BV
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60