Trial Outcomes & Findings for A Prospective Multi-center Study on Total Hip Arthroplasty With E1 (NCT NCT01883492)
NCT ID: NCT01883492
Last Updated: 2020-02-17
Results Overview
Vector wear, which is defined as movement (difference of femoral prosthetic head positions) between immediate postoperative and 2 years postoperative periods. There is no lower and upper limit, actual measured results. The outcome can be negative value.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
153 participants
Primary outcome timeframe
Immediate postoperative and 2 year postoperatively
Results posted on
2020-02-17
Participant Flow
Participant milestones
| Measure |
BIOLOX Delta Head
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
CoCr Head
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
78
|
|
Overall Study
COMPLETED
|
62
|
67
|
|
Overall Study
NOT COMPLETED
|
13
|
11
|
Reasons for withdrawal
| Measure |
BIOLOX Delta Head
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
CoCr Head
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
|
Overall Study
Surgery on contra-lateral hip
|
0
|
1
|
|
Overall Study
Poor X-ray quality
|
7
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
inappropriate implant used
|
1
|
1
|
|
Overall Study
bone anatomy did not meet study criteria
|
1
|
1
|
Baseline Characteristics
A Prospective Multi-center Study on Total Hip Arthroplasty With E1
Baseline characteristics by cohort
| Measure |
BIOLOX Delta Head
n=62 Participants
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
CoCr Head
n=67 Participants
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.90 years
STANDARD_DEVIATION 7.16 • n=99 Participants
|
61.94 years
STANDARD_DEVIATION 7.26 • n=107 Participants
|
61.92 years
STANDARD_DEVIATION 7.18 • n=206 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
129 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
62 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
129 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Japan
|
62 participants
n=99 Participants
|
67 participants
n=107 Participants
|
129 participants
n=206 Participants
|
|
Harris Hip Score
|
55.11 score on scale
STANDARD_DEVIATION 11.65 • n=99 Participants
|
52.63 score on scale
STANDARD_DEVIATION 11.67 • n=107 Participants
|
53.83 score on scale
STANDARD_DEVIATION 11.68 • n=206 Participants
|
|
WOMAC osteoarthritis index
|
40.75 score on scale
STANDARD_DEVIATION 17.09 • n=99 Participants
|
41.24 score on scale
STANDARD_DEVIATION 15.29 • n=107 Participants
|
41.00 score on scale
STANDARD_DEVIATION 16.13 • n=206 Participants
|
|
UCLA Activity Score
|
2.95 score on scale
STANDARD_DEVIATION 0.95 • n=99 Participants
|
3.28 score on scale
STANDARD_DEVIATION 1.10 • n=107 Participants
|
3.12 score on scale
STANDARD_DEVIATION 1.04 • n=206 Participants
|
PRIMARY outcome
Timeframe: Immediate postoperative and 2 year postoperativelyPopulation: Participants, whose x-ray taken at 2 year follow-up visit being available.
Vector wear, which is defined as movement (difference of femoral prosthetic head positions) between immediate postoperative and 2 years postoperative periods. There is no lower and upper limit, actual measured results. The outcome can be negative value.
Outcome measures
| Measure |
BIOLOX Delta Head
n=57 Participants
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
CoCr Head
n=63 Participants
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
|---|---|---|
|
Polyethylene Wear Between Immediate Postoperative and 2 Year Postoperative Period
|
0.42 millimeter
Standard Deviation 1.08
|
0.15 millimeter
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: 6 month postoperativePopulation: 1 patient in BIOLOX delta head group and 13 patients in CoCr head group missed collecting Harris Hip Score at 6 month visit.
Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are "pain", "function", "absence of deformity" and "range of hip motion". Minimum possible score is 0 and maximum possible score is 100. Higher score means better outcome.
Outcome measures
| Measure |
BIOLOX Delta Head
n=61 Participants
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
CoCr Head
n=54 Participants
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
|---|---|---|
|
Harris Hip Score at 6 Month Follow-up Visit
|
92.67 score on a scale
Standard Deviation 8.05
|
92.61 score on a scale
Standard Deviation 7.92
|
SECONDARY outcome
Timeframe: 1 year postoperativePopulation: 1 patient in BIOLOX delta head group and 6 patients in CoCr head group missed collecting Harris Hip Score at 1 year visit.
Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are "pain", "function", "absence of deformity" and "range of hip motion". Minimum possible score is 0 and maximum possible score is 100. Higher score means better outcome.
Outcome measures
| Measure |
BIOLOX Delta Head
n=61 Participants
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
CoCr Head
n=61 Participants
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
|---|---|---|
|
Harris Hip Score at 1 Year Follow-up Visit
|
95.23 score on a scale
Standard Deviation 6.10
|
94.52 score on a scale
Standard Deviation 6.76
|
SECONDARY outcome
Timeframe: 2 year postoperativePopulation: 3 patients in BIOLOX delta head group and 9 patients in CoCr head group missed collecting Harris Hip Score at 2 year visit.
Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are "pain", "function", "absence of deformity" and "range of hip motion". Minimum possible score is 0 and maximum possible score is 100. Higher score means better outcome.
Outcome measures
| Measure |
BIOLOX Delta Head
n=59 Participants
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
CoCr Head
n=58 Participants
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
|---|---|---|
|
Harris Hip Score at 2 Year Follow-up Visit
|
96.15 score on a scale
Standard Deviation 5.44
|
96.28 score on a scale
Standard Deviation 5.69
|
SECONDARY outcome
Timeframe: 3 year postoperativePopulation: 12 patients in BIOLOX delta head group and 12 patients in CoCr head group missed collecting Harris Hip Score at 3 year visit.
Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are "pain", "function", "absence of deformity" and "range of hip motion". Minimum possible score is 0 and maximum possible score is 100. Higher score means better outcome.
Outcome measures
| Measure |
BIOLOX Delta Head
n=50 Participants
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
CoCr Head
n=55 Participants
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
|---|---|---|
|
Harris Hip Score at 3 Year Follow-up Visit
|
96.30 score on a scale
Standard Deviation 4.56
|
96.82 score on a scale
Standard Deviation 6.03
|
SECONDARY outcome
Timeframe: 6 month postoperativePopulation: 6 patients in BIOLOX delta head group and 11 patients in CoCr head group missed colleting WOMAC questionnaire at 6 month visit.
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items. The scores for each subscale are summed up, with a possible score range of 0-20 for "Pain", 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Outcome measures
| Measure |
BIOLOX Delta Head
n=56 Participants
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
CoCr Head
n=56 Participants
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
|---|---|---|
|
WOMAC Osteoarthritis Index at 6 Month Follow-up Visit
|
9.27 score on a scale
Standard Deviation 9.75
|
10.43 score on a scale
Standard Deviation 9.62
|
SECONDARY outcome
Timeframe: 1 year postoperativePopulation: 6 patients in BIOLOX delta head group and 13 patients in CoCr head group missed colleting WOMAC questionnaire at 1 year visit.
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items. The scores for each subscale are summed up, with a possible score range of 0-20 for "Pain", 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Outcome measures
| Measure |
BIOLOX Delta Head
n=56 Participants
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
CoCr Head
n=54 Participants
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
|---|---|---|
|
WOMAC Osteoarthritis Index at 1 Year Follow-up Visit
|
9.86 score on a scale
Standard Deviation 13.52
|
9.57 score on a scale
Standard Deviation 9.23
|
SECONDARY outcome
Timeframe: 2 year postoperativePopulation: 9 patients in BIOLOX delta head group and 16 patients in CoCr head group missed colleting WOMAC questionnaire at 2 year visit.
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items. The scores for each subscale are summed up, with a possible score range of 0-20 for "Pain", 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Outcome measures
| Measure |
BIOLOX Delta Head
n=53 Participants
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
CoCr Head
n=51 Participants
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
|---|---|---|
|
WOMAC Osteoarthritis Index at 2 Year Follow-up Visit
|
7.85 score on a scale
Standard Deviation 8.88
|
7.80 score on a scale
Standard Deviation 10.32
|
SECONDARY outcome
Timeframe: 3 year postoperativePopulation: 14 patients in BIOLOX delta head group and 17 patients in CoCr head group missed colleting WOMAC questionnaire at 3 year visit.
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items. The scores for each subscale are summed up, with a possible score range of 0-20 for "Pain", 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Outcome measures
| Measure |
BIOLOX Delta Head
n=48 Participants
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
CoCr Head
n=50 Participants
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
|---|---|---|
|
WOMAC Osteoarthritis Index at 3 Year Follow-up Visit
|
8.29 score on a scale
Standard Deviation 9.31
|
6.84 score on a scale
Standard Deviation 8.00
|
SECONDARY outcome
Timeframe: 6 month postoperativePopulation: 4 patients in BIOLOX delta head group and 12 patients in CoCr head group missed colleting UCLA Activity score at 6 month visit.
University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity. The score ranges from 1 to 10 (1 point increment), higher score means higher activity level.
Outcome measures
| Measure |
BIOLOX Delta Head
n=58 Participants
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
CoCr Head
n=55 Participants
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
|---|---|---|
|
UCLA Activity Score at 6 Month Follow-up Visit
|
5.19 score on a scale
Standard Deviation 1.42
|
4.75 score on a scale
Standard Deviation 1.28
|
SECONDARY outcome
Timeframe: 1 year postoperativePopulation: 2 patients in BIOLOX delta head group and 8 patients in CoCr head group missed colleting UCLA Activity score at 1 year visit.
University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity. The score ranges from 1 to 10 (1 point increment), higher score means higher activity level.
Outcome measures
| Measure |
BIOLOX Delta Head
n=60 Participants
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
CoCr Head
n=59 Participants
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
|---|---|---|
|
UCLA Activity Score at 1 Year Follow-up Visit
|
5.45 score on a scale
Standard Deviation 1.52
|
5.03 score on a scale
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: 2 year postoperativePopulation: 3 patients in BIOLOX delta head group and 9 patients in CoCr head group missed colleting UCLA Activity score at 2 year visit.
University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity. The score ranges from 1 to 10 (1 point increment), higher score means higher activity level.
Outcome measures
| Measure |
BIOLOX Delta Head
n=59 Participants
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
CoCr Head
n=58 Participants
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
|---|---|---|
|
UCLA Activity Score at 2 Year Follow-up Visit
|
5.53 score on a scale
Standard Deviation 1.38
|
5.31 score on a scale
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: 3 year postoperativePopulation: 12 patients in BIOLOX delta head group and 11 patients in CoCr head group missed colleting UCLA Activity score at 3 year visit.
University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity. The score ranges from 1 to 10 (1 point increment), higher score means higher activity level.
Outcome measures
| Measure |
BIOLOX Delta Head
n=50 Participants
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
CoCr Head
n=56 Participants
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
|---|---|---|
|
UCLA Activity Score at 3 Year Follow-up Visit
|
5.42 score on a scale
Standard Deviation 1.49
|
5.43 score on a scale
Standard Deviation 1.36
|
Adverse Events
BIOLOX Delta Head
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
CoCr Head
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BIOLOX Delta Head
n=62 participants at risk
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
CoCr Head
n=67 participants at risk
Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Intraoperative Trochanteric Fracture
|
1.6%
1/62 • Number of events 1 • 3 year after surgery
|
0.00%
0/67 • 3 year after surgery
|
|
Nervous system disorders
Femoral Nerve Palsy
|
1.6%
1/62 • Number of events 1 • 3 year after surgery
|
0.00%
0/67 • 3 year after surgery
|
|
Musculoskeletal and connective tissue disorders
Inappropriate femoral stem position
|
0.00%
0/62 • 3 year after surgery
|
1.5%
1/67 • Number of events 1 • 3 year after surgery
|
Additional Information
Senior Manager of Clinical Affairs
Zimmer Biomet G.K.
Phone: +81-3-6402-6610
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place