Trial Outcomes & Findings for Accolade® TMZF® Hip Stem Outcomes Study (NCT NCT00957658)
NCT ID: NCT00957658
Last Updated: 2017-08-14
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
241 participants
Primary outcome timeframe
2 years
Results posted on
2017-08-14
Participant Flow
241 participants/249 hips - 7 censored participants/7 hips = 234 participants/242 hips
Participant milestones
| Measure |
Accolade® TMZF® Hip Stem
Accolade® TMZF® Hip Stem Study Device. Participants have one or both hips replaced. If both hips were replaced, but only one hip completed the primary endpoint, the participant is counted as completed.
|
|---|---|
|
Overall Study
STARTED
|
234
|
|
Overall Study
COMPLETED
|
169
|
|
Overall Study
NOT COMPLETED
|
65
|
Reasons for withdrawal
| Measure |
Accolade® TMZF® Hip Stem
Accolade® TMZF® Hip Stem Study Device. Participants have one or both hips replaced. If both hips were replaced, but only one hip completed the primary endpoint, the participant is counted as completed.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Withdrawal by Subject
|
12
|
|
Overall Study
Revision
|
1
|
|
Overall Study
Incomplete 2 yr data
|
28
|
|
Overall Study
Site termination
|
10
|
|
Overall Study
unwilling/unable to return
|
2
|
|
Overall Study
surgery cancelled
|
2
|
|
Overall Study
Protocol Violation
|
5
|
Baseline Characteristics
Accolade® TMZF® Hip Stem Outcomes Study
Baseline characteristics by cohort
| Measure |
Accolade® TMZF® Hip Stem
n=234 Participants
Accolade® TMZF® Hip Stem Study Device
|
|---|---|
|
Age, Continuous
|
68.94 years
STANDARD_DEVIATION 9.77 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
149 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
80 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
234 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Accolade® TMZF® Hip Stem
n=174 hips
Accolade® TMZF® Hip Stem Study Device
|
|---|---|
|
Combined Percentage (%) Cases Without Aseptic Loosening, Intraoperative Femoral Fracture or Thigh Pain
|
98.85 percentage of hips
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Participants with available data: 111 hips in 106 participants had a radiographic evaluation at 5 years.
Aseptic loosening is defined as a continuous radiolucency that surrounds the entire femoral stem porous coating-bone interface and that measures greater than 2 mm in thickness, and 5 mm or more of stem subsidence. Continuous radiolucency must be present in Zones 1, 2, 6 and 7 of the AP radiographic view and/or present in Zones 8, 9, 13 and 14 of the M/L radiographic view.
Outcome measures
| Measure |
Accolade® TMZF® Hip Stem
n=111 hips
Accolade® TMZF® Hip Stem Study Device
|
|---|---|
|
Percentage (%) of Hip Stems With Aseptic Loosening
|
0 percentage of hips
|
SECONDARY outcome
Timeframe: 2 and 5 yearsPopulation: Participants with available data: The revision/removal rate of any total hip replacement component at 2 years is reported for 182 hips/176 participants. The revision/removal rate of any component at 5 years is reported for 141 hips/136 participants.
The percentage (%) of hips with revision or removal of any total hip replacement component (acetabular cup, femoral stem or femoral head) is reported at the 2 and 5 year postoperative intervals.
Outcome measures
| Measure |
Accolade® TMZF® Hip Stem
n=182 hip
Accolade® TMZF® Hip Stem Study Device
|
|---|---|
|
Revision/Removal Rates
Revision/removal rate % at 2 years
|
1.65 percentage of hips/any component revised
|
|
Revision/Removal Rates
Revision/removal rate % at 5 years
|
2.84 percentage of hips/any component revised
|
SECONDARY outcome
Timeframe: Preoperative, 2 and 5 yearsPopulation: Participants with available data: A total of 195 hips had a preoperative score, 174 had a 2 year score, and 117 had a 5 year score.
The change in HHS is reported by comparing the mean preoperative, 2 and 5 year postoperative scores. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent, 80-89 = good, 70-79 = fair, 0-69 = poor.
Outcome measures
| Measure |
Accolade® TMZF® Hip Stem
n=195 hips
Accolade® TMZF® Hip Stem Study Device
|
|---|---|
|
Change in Harris Hip Score (HHS)
Mean HHS score Preoperative (n=195)
|
50.1 units on a scale
Standard Deviation 11.99
|
|
Change in Harris Hip Score (HHS)
Mean HHS score 2 years (n=174)
|
89.4 units on a scale
Standard Deviation 12.67
|
|
Change in Harris Hip Score (HHS)
Mean HHS score 5 years (N=117)
|
92.2 units on a scale
Standard Deviation 12.61
|
SECONDARY outcome
Timeframe: Preoperative, 2 and 5 yearsPopulation: Participants with available data: A total of 217 hips had preoperative scores, 175 had 2 year and 121 had 5 year scores.
The change in SF-12 is reported by comparing the mean preoperative, 2 and 5 year postoperative scores.The SF-12 Health Survey is a 12-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 |
Accolade® TMZF® Hip Stem
n=217 hips
Accolade® TMZF® Hip Stem Study Device
|
|---|---|
|
Change in SF-12 Score
Mean SF12 Physical Preoperative (N=217)
|
32.3 units on a scale
Standard Deviation 8.3
|
|
Change in SF-12 Score
mean SF12 Mental Preoperative (N=217)
|
49.1 units on a scale
Standard Deviation 11.99
|
|
Change in SF-12 Score
Mean SF12 Physical 2 years (N=175)
|
45.6 units on a scale
Standard Deviation 11.17
|
|
Change in SF-12 Score
Mean SF12 Mental 2 years (N=175)
|
54.2 units on a scale
Standard Deviation 8.41
|
|
Change in SF-12 Score
Mean SF-12 Physical 5 years (N=121)
|
44.8 units on a scale
Standard Deviation 10.62
|
|
Change in SF-12 Score
Mean SF-12 Mental 5 years (N=121)
|
53.4 units on a scale
Standard Deviation 9.45
|
SECONDARY outcome
Timeframe: Preoperative, 2 and 5 yearsPopulation: Participants with available data: A total of 231 hips had a preoperative score, 181 had a 2 year, and 129 had a 5 year score.
The change in LEAS is reported by comparing the mean preoperative, 2 and 5 year postoperative scores.The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. The mean preoperative, 2 and 5 year scores are reported to assess improvement.
Outcome measures
| Measure |
Accolade® TMZF® Hip Stem
n=231 hips
Accolade® TMZF® Hip Stem Study Device
|
|---|---|
|
Change in Lower Extremity Activity Scale (LEAS) Score
Mean LEAS Preoperative (n=231)
|
8.4 units on a scale
Standard Deviation 3.32
|
|
Change in Lower Extremity Activity Scale (LEAS) Score
Mean LEAS 2 year (N=181)
|
10.4 units on a scale
Standard Deviation 3.18
|
|
Change in Lower Extremity Activity Scale (LEAS) Score
Mean LEAS 5 year (N=129)
|
10.2 units on a scale
Standard Deviation 3.34
|
SECONDARY outcome
Timeframe: 6 months, 1 year and 2 yearsPopulation: Participants with available data: A total of 206 hips had 6 month data; a total of 203 hips had 1 year data; a total of 178 hips had 2 year data. Percentage of participants who were satisfied with the result is reported for each expectation at these intervals.
The PEQ is a study sponsor generated outcomes form. It is a one page questionnaire completed by the participant to assess lifestyle recovery post-surgery. Preoperatively, participants are asked to identify 3 of 12 different expectations that they most want to achieve after hip surgery. At 6 months,1 year and 2 years post-surgery participants evaluated the 3 expectations they identified and assessed their overall satisfaction and percent achievement. EXPECTATIONS KEY: Participate in recreational activities (dancing,traveling,gardening) Exercise or participate in sports Independently perform household chores/daily routine Easily change position,sit to stand/stand to sit Remove need for cane crutch or walker Use stairs normally step by step Ability to sleep through night Maintain social activites,caring for someone,playing with children Use public transportation or drive Maintain psychological well-being Maintain sexual activity Maintain employment
Outcome measures
| Measure |
Accolade® TMZF® Hip Stem
n=206 hips
Accolade® TMZF® Hip Stem Study Device
|
|---|---|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Recreation 1 yr (n=95)
|
88.4 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Recreation 6 mo (n=97)
|
84.5 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Recreation 2 yr (n=76)
|
85.5 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Exercise/sports 6 mo (n=79)
|
89.9 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Exercise/sports 1 yr (n=79)
|
89.9 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Exercise/sports 2 yr (n=67)
|
91 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Chores 6 mo (n=71)
|
91.5 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Chores 1 yr (n=65)
|
86.2 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Chores 2 yr (n=58)
|
96.6 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Change position 6 mo (n=57)
|
87.7 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Change position 1 yr (n=58)
|
87.9 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Change position 2 yr (n=43)
|
90.7 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
No cane/crutch/walker 6 mo (n=57)
|
94.7 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
No cane/crutch/walker 1 yr (n=53)
|
94.3 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
No cane/crutch/walker 2 yr (n=49)
|
93.9 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Stairs normally 6 mo (n=52)
|
80.8 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Stairs normally 1 yr (n=58)
|
86.2 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Stairs normally 2 yr (n=45)
|
91.1 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Sleep 6 mo (n=52)
|
71.2 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Sleep 1 yr (n=49)
|
77.6 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Sleep 2 yr (n=51)
|
84.3 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Maintain activities 6 mo (n=44)
|
90.9 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Maintain activities 1 yr (n=41)
|
87.8 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Maintain activities 2 yr (n=38)
|
94.7 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Transportation 6 mo (n=27)
|
96.3 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Transportation 1 yr (n=29)
|
96.6 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Transportation 2 yr (n=24)
|
95.8 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Well-being 6 mo (n=21)
|
85.7 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Well-being 1 yr (n=20)
|
95 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Well-being 2 yr (n=15)
|
86.7 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Sexual activity 6 mo (n=15)
|
80 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Sexual activity 1 yr (n=13)
|
84.6 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Sexual activity 2 yr (n=12)
|
66.7 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Employment 6 mo (n=12)
|
83.3 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Employment 1 yr (n=11)
|
81.8 percentage of particpants
|
|
PEQ (Patient Expectation Questionnaire) Overall Satisfaction
Employment 2 yr (n=8)
|
87.5 percentage of particpants
|
SECONDARY outcome
Timeframe: 6 months, 1 year, 2 yearsPopulation: Participants with available data: A total of 206 hips had 6 month data; a total of 203 hips had 1 year data; a total of 178 hips had 2 year data. Participants select 3 expectations and assess percent achievement (100%,75%,50%,25%,or 0%) at 6 mos, 1 yr and 2 yrs.
The PEQ is a study sponsor generated outcomes form. It is a one page questionnaire completed by the participant to assess lifestyle recovery post-surgery. Preoperatively, participants are asked to identify 3 of 12 different expectations that they most want to achieve after hip surgery. At 6 months,1 year and 2 years post-surgery participants evaluated the 3 expectations they identified and assessed their overall satisfaction and percent achievement. EXPECTATIONS KEY: Participate in recreational activities (dancing,traveling,gardening) Exercise or participate in sports Independently perform household chores/daily routine Easily change position,sit to stand/stand to sit Remove need for cane crutch or walker Use stairs normally step by step Ability to sleep through night Maintain social activites,caring for someone,playing with children Use public transportation or drive Maintain psychological well-being Maintain sexual activity Maintain employment
Outcome measures
| Measure |
Accolade® TMZF® Hip Stem
n=206 hips
Accolade® TMZF® Hip Stem Study Device
|
|---|---|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Recreation 100% 6 mo (n=101)
|
42.6 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Recreation 100% 1 yr (n=97)
|
55.7 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Recreation 100% 2 yr (n=83)
|
47.0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Recreation 75% 6 mo (n=101)
|
33.7 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Recreation 75% 1 yr (n=97)
|
28.9 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Recreation 75% 2 yr (n=83)
|
28.9 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Recreation 50% 6 mo (n=101)
|
9.9 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Recreation 50% 1 yr (n=97)
|
8.2 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Recreation 50% 2 yr (n=83)
|
12.0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Recreation 25% 6 mo (n=101)
|
11.9 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Recreation 25% 1 yr (n=97)
|
3.1 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Recreation 25% 2 yr (n=83)
|
8.4 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Recreation 0% 6 mo (n=101)
|
2.0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Recreation 0% 1 yr (n=97)
|
4.1 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Recreation 0% 2 yr (n=83)
|
3.6 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Exercise/sports 100% 6 mo (n=81)
|
43.2 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Exercise/sports 100% 1 yr (n=82)
|
51.2 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Exercise/sports 100% 2 yr (n=74)
|
44.6 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Exercise/sports 75% 6 mo (n=81)
|
37.0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Exercise/sports 75% 1 yr (n=82)
|
29.3 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Exercise/sports 75% 2 yr (n=74)
|
32.4 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Exercise/sports 50% 6 mo (n=81)
|
9.9 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Exercise/sports 50% 1 yr (n=82)
|
9.8 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Exercise/sports 50% 2 yr (n=74)
|
5.4 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Exercise/sports 25% 6 mo (n=81)
|
4.9 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Exercise/sports 25% 1 yr (n=82)
|
8.5 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Exercise/sports 25% 2 yr (n=74)
|
13.5 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Exercise/sports 0% 6 mo (n=81)
|
4.9 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Exercise/sports 0% 1 yr (n=82)
|
1.2 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Exercise/sports 0% 2 yr (n=74)
|
4.1 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Chores 100% 6 mo (n=74)
|
71.6 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Chores 100% 1 yr (n=72)
|
65.3 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Chores 100% 2 yr (n=65)
|
58.5 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Chores 75% 6 mos (n=74)
|
14.9 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Chores 75% 1 yr (n=72)
|
19.4 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Chores 75% 2 yr (n=65)
|
27.7 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Chores 50% 6 mo (n=74)
|
6.8 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Chores 50% 1 yr (n=72)
|
5.6 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Chores 50% 2 yr (n=65)
|
7.7 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Chores 25% 6 mo (n=74)
|
6.8 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Chores 25% 1 yr (n=72)
|
6.9 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Chores 25% 2 yr (n=65)
|
6.2 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Chores 0% 6 mo (n=74)
|
0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Chores 0% 1 yr (n=72)
|
2.8 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Chores 0% 2 yr (n=65)
|
0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Change position 100% 6 mo (n=63)
|
58.7 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Change position 100% 1 yr (n=61)
|
60.7 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Change position 100% 2 yr (n=49)
|
57.1 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Change position 75% 6 mo (n=63)
|
28.6 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Change position 75% 1 yr (n=61)
|
31.1 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Change position 75% 2 yr (n=49)
|
26.5 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Change position 50% 6 mo (n=63)
|
6.3 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Change position 50% 1 yr (n=61)
|
8.2 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Change position 50% 2 yr (n=49)
|
14.3 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Change position 25% 6 mo (n=63)
|
6.3 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Change position 25% 1 yr (n=61)
|
0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Change position 25% 2 yr (n=49)
|
2.0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Change position 0% 6 mo (n=63)
|
0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Change position 0% 1 yr (n=61)
|
0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Change position 0% 2 yr (n=49)
|
0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
No cane/crutch/walker 100% 6 mo (n=58)
|
79.3 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
No cane/crutch/walker 100% 1 yr (n=54)
|
79.6 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
No cane/crutch/walker 100% 2 yr (n=53)
|
77.4 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
No cane/crutch/walker 75% 6 mo (n=58)
|
12.1 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
No cane/crutch/walker 75% 1 yr (n=54)
|
7.4 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
No cane/crutch/walker 75% 2 yr (n=53)
|
7.5 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
No cane/crutch/walker 50% 6 mo (n=58)
|
1.7 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
No cane/crutch/walker 50% 1 yr (n=54)
|
7.4 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
No cane/crutch/walker 50% 2 yr (n=53)
|
7.5 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
No cane/crutch/walker 25% 6 mo (n=58)
|
5.2 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
No cane/crutch/walker 25% 1 yr (n=54)
|
5.6 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
No cane/crutch/walker 25% 1 yr (n=53)
|
5.7 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
No cane/crutch/walker 0% 6 mo (n=58)
|
1.7 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
No cane/crutch/walker 0% 1 yr (n=54)
|
0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
No cane/crutch/walker 0% 2 yr (n=53)
|
1.9 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Stairs normally 100% 6 mo (n=56)
|
51.8 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Stairs normally 100% 1 yr (n=59)
|
62.7 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Stairs normally 100% 2 yr (n=47)
|
55.3 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Stairs normally 75% 6 mo (n=56)
|
25 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Stairs normally 75% 1 yr (n=59)
|
6.8 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Stairs normally 75% 2 yr (n=47)
|
8.5 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Stairs normally 50% 6 mo (n=56)
|
7.1 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Stairs normally 50% 1 yr (n=59)
|
18.6 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Stairs normally 50% 2 yr (n=47)
|
19.1 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Stairs normally 25% 6 mo (n=56)
|
8.9 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Stairs normally 25% 1 yr (n=59)
|
8.5 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Stairs normally 25% 2 yr (n=47)
|
10.6 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Stairs normally 0% 6 mo (n=56)
|
7.1 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Stairs normally 0% 1 yr (n=59)
|
3.4 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Stairs normally 0% 2 yr (n=47)
|
6.4 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Sleep 100% 6 mo (n=55)
|
43.6 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Sleep 100% 1 yr (n=53)
|
39.6 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Sleep 100% 2 yr (n=51)
|
51.0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Sleep 75% 6 mo (n=55)
|
20.0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Sleep 75% 1 yr (n=53)
|
28.3 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Sleep 75% 2 yr (n=51)
|
17.6 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Sleep 50% 6 mo (n=55)
|
18.2 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Sleep 50% 1 yr (n=53)
|
5.7 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Sleep 50% 2 yr (n=51)
|
17.6 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Sleep 25% 6 mo (n=55)
|
7.3 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Sleep 25% 1 yr (n=53)
|
15.1 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Sleep 25% 2 yr (n=51)
|
7.8 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Sleep 0% 6 mo (n=55)
|
10.9 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Sleep 0% 1 yr (n=53)
|
11.3 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Sleep 0% 2 yr (n=51)
|
5.9 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Maintain activities 100% 6 mo (n=47)
|
61.7 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Maintain activities 100% 1 yr (n=44)
|
65.9 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Maintain activities 100% 2 yr (n=40)
|
62.5 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Maintain activities 75% 6 mo (n=47)
|
19.1 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Maintain activities 75% 1 yr (n=44)
|
18.2 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Maintain activities 75% 2 yr (n=40)
|
17.5 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Maintain activities 50% 6 mo (n=47)
|
12.8 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Maintain activities 50% 1 yr (n=44)
|
0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Maintain activities 50% 2 yr (n=40)
|
15.0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Maintain activities 25% 6 mo (n=47)
|
4.3 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Maintain activities 25% 1 yr (n=44)
|
9.1 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Maintain activities 25% 2 yr (n=40)
|
5.0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Maintain activities 0% 6 mo (n=47)
|
2.1 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Maintain activities 0% 1 yr (n=44)
|
6.8 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Maintain activities 0% 2 yr (n=40)
|
0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Transportation 100% 6 mo (n=30)
|
86.7 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Transportation 100% 1 yr (n=32)
|
90.6 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Transportation 100% 2 yr (n=27)
|
77.8 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Transportation 75% 6 mo (n=30)
|
10.0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Transportation 75% 1 yr (n=32)
|
6.3 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Transportation 75% 2 yr (n=27)
|
14.8 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Transportation 50% 6 mo (n=30)
|
3.3 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Transportation 50% 1 yr (n=32)
|
0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Transportation 50% 2 yr (n=27)
|
0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Transportation 25% 6 mo (n=30)
|
0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Transportation 25% 1 yr (n=32)
|
0.0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Transportation 25% 2 yr (n=27)
|
3.7 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Transportation 0% 6 mo (n=30)
|
0.0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Transportation 0% 1 yr (n=32)
|
3.1 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Transportation 0% 2 yr (n=27)
|
3.7 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Well-being 100% 6 mo (n=22)
|
54.5 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Well-being 100% 1 yr (n=24)
|
58.3 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Well-being 100% 2 yr (n=17)
|
47.1 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Well-being 75% 6 mo (n=22)
|
31.8 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Well-being 75% 1 yr (n=24)
|
33.3 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Well-being 75% 2 yr (n=17)
|
35.3 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Well-being 50% 6 mo (n=22)
|
9.1 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Well-being 50% 1 yr (n=24)
|
0.0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Well-being 50% 2 yr (n=17)
|
11.8 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Well-being 25% 6 mo (n=22)
|
4.5 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Well-being 25% 1 yr (n=24)
|
8.3 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Well-being 25% 2 yr (n=17)
|
5.9 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Well-being 0% 6 mo (n=22)
|
0.0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Well-being 0% 1 yr (n=24)
|
0.0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Well-being 0% 2 yr (n=17)
|
0.0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Sexual activity 100% 6 mo (n=15)
|
26.7 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Sexual activity 100% 1 yr (n=14)
|
57.1 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Sexual activity 100% 2 yr (n=14)
|
35.7 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Sexual activity 75% 6 mo (n=15)
|
33.3 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Sexual activity 75% 1 yr (n=14)
|
7.1 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Sexual activity 75% 2 yr (n=14)
|
14.3 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Sexual activity 50% 6 mo (n=15)
|
20.0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Sexual activity 50% 1 yr (n=14)
|
14.3 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Sexual activity 50% 2 yr (n=14)
|
14.3 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Sexual activity 25% 6 mo (n=15)
|
20.0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Sexual activity 25% 1 yr (n=14)
|
14.3 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Sexual activity 25% 2 yr (n=14)
|
28.6 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Sexual activity 0% 6 mo (n=15)
|
0.0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Sexual activity 0% 1 yr (n=14)
|
7.1 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Sexual activity 0% 2 yr (n=14)
|
7.1 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Employment 100% 6 mo (n=12)
|
83.3 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Employment 100% 1 yr (n=12)
|
75.0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Employment 100% 2 yr (n=9)
|
88.9 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Employment 75% 6 mo (n=12)
|
0.0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Employment 75% 1 yr (n=12)
|
0.0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Employment 75% 2 yr (n=9)
|
0.0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Employment 50% 6 mo (n=12)
|
0.0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Employment 50% 1 yr (n=12)
|
8.3 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Employment 50% 2 yr (n=9)
|
0.0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Employment 25% 6 mo (n=12)
|
0.0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Employment 25% 1 yr (n=12)
|
8.3 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Employment 25% 2 yr (n=9)
|
0.0 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Employment 0% 6 mo (n=12)
|
16.7 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Employment 0% 1 yr (n=12)
|
8.3 percentage of participants
|
|
PEQ (Patient Evaluation Questionnaire) Percent Achievement
Employment 0% 2 yr (n=9)
|
11.1 percentage of participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Participants with available data: 97 hips were evaluated for wear rate at 5 years.
The linear wear rate of the polyethylene acetabular insert is measured radiographically and reported at 5 years.
Outcome measures
| Measure |
Accolade® TMZF® Hip Stem
n=97 hips
Accolade® TMZF® Hip Stem Study Device
|
|---|---|
|
Acetabular Insert Wear
|
0.0342 millimeters per year
Standard Deviation 0.0336
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Participants with available data: 107 hips had DXA scan T-scores at 5 years.
DXA is a bone densitometry scan that measures bone mineral density and assigns a T-score. This score shows the amount of bone a patient has compared with a young adult of the same gender with peak bone mass. A score above -1 is considered normal. A score between -1 and -2.5 is classified as osteopenia (low bone mass). A score below -2.5 is defined as osteoporosis.
Outcome measures
| Measure |
Accolade® TMZF® Hip Stem
n=107 hips
Accolade® TMZF® Hip Stem Study Device
|
|---|---|
|
Wrist DXA Scan Analysis
|
-0.4 T-score
Standard Deviation 1.05
|
Adverse Events
Accolade TMZF Hip Stem
Serious events: 65 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Accolade TMZF Hip Stem
n=234 participants at risk
Participants who received the Accolade TMZF Hip Stem
|
|---|---|
|
Blood and lymphatic system disorders
Non-operative site
|
0.85%
2/234 • Number of events 2 • This study requires that all operative site and serious systemic adverse events be reported from enrollment to 5 years postoperative. Censored protocol violations were not included as at risk participants.
Elective procedures not included.e.g.non-study joint replacement/revision,rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery. Industry standard AE terms not used; specific AE terms not used for all AEs
|
|
Cardiac disorders
Non-operative site
|
4.3%
10/234 • Number of events 13 • This study requires that all operative site and serious systemic adverse events be reported from enrollment to 5 years postoperative. Censored protocol violations were not included as at risk participants.
Elective procedures not included.e.g.non-study joint replacement/revision,rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery. Industry standard AE terms not used; specific AE terms not used for all AEs
|
|
Endocrine disorders
Non-operative site
|
0.43%
1/234 • Number of events 1 • This study requires that all operative site and serious systemic adverse events be reported from enrollment to 5 years postoperative. Censored protocol violations were not included as at risk participants.
Elective procedures not included.e.g.non-study joint replacement/revision,rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery. Industry standard AE terms not used; specific AE terms not used for all AEs
|
|
Gastrointestinal disorders
Non-operative site
|
3.0%
7/234 • Number of events 7 • This study requires that all operative site and serious systemic adverse events be reported from enrollment to 5 years postoperative. Censored protocol violations were not included as at risk participants.
Elective procedures not included.e.g.non-study joint replacement/revision,rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery. Industry standard AE terms not used; specific AE terms not used for all AEs
|
|
General disorders
Non-operative site
|
1.7%
4/234 • Number of events 4 • This study requires that all operative site and serious systemic adverse events be reported from enrollment to 5 years postoperative. Censored protocol violations were not included as at risk participants.
Elective procedures not included.e.g.non-study joint replacement/revision,rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery. Industry standard AE terms not used; specific AE terms not used for all AEs
|
|
Infections and infestations
Non-operative site
|
0.85%
2/234 • Number of events 2 • This study requires that all operative site and serious systemic adverse events be reported from enrollment to 5 years postoperative. Censored protocol violations were not included as at risk participants.
Elective procedures not included.e.g.non-study joint replacement/revision,rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery. Industry standard AE terms not used; specific AE terms not used for all AEs
|
|
Infections and infestations
Operative site
|
0.85%
2/234 • Number of events 2 • This study requires that all operative site and serious systemic adverse events be reported from enrollment to 5 years postoperative. Censored protocol violations were not included as at risk participants.
Elective procedures not included.e.g.non-study joint replacement/revision,rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery. Industry standard AE terms not used; specific AE terms not used for all AEs
|
|
Injury, poisoning and procedural complications
Non-operative site
|
0.85%
2/234 • Number of events 2 • This study requires that all operative site and serious systemic adverse events be reported from enrollment to 5 years postoperative. Censored protocol violations were not included as at risk participants.
Elective procedures not included.e.g.non-study joint replacement/revision,rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery. Industry standard AE terms not used; specific AE terms not used for all AEs
|
|
Injury, poisoning and procedural complications
Operative site
|
1.3%
3/234 • Number of events 3 • This study requires that all operative site and serious systemic adverse events be reported from enrollment to 5 years postoperative. Censored protocol violations were not included as at risk participants.
Elective procedures not included.e.g.non-study joint replacement/revision,rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery. Industry standard AE terms not used; specific AE terms not used for all AEs
|
|
Musculoskeletal and connective tissue disorders
Non-operative site
|
3.4%
8/234 • Number of events 8 • This study requires that all operative site and serious systemic adverse events be reported from enrollment to 5 years postoperative. Censored protocol violations were not included as at risk participants.
Elective procedures not included.e.g.non-study joint replacement/revision,rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery. Industry standard AE terms not used; specific AE terms not used for all AEs
|
|
Musculoskeletal and connective tissue disorders
Operative site
|
6.8%
16/234 • Number of events 18 • This study requires that all operative site and serious systemic adverse events be reported from enrollment to 5 years postoperative. Censored protocol violations were not included as at risk participants.
Elective procedures not included.e.g.non-study joint replacement/revision,rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery. Industry standard AE terms not used; specific AE terms not used for all AEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-operative Site
|
2.6%
6/234 • Number of events 7 • This study requires that all operative site and serious systemic adverse events be reported from enrollment to 5 years postoperative. Censored protocol violations were not included as at risk participants.
Elective procedures not included.e.g.non-study joint replacement/revision,rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery. Industry standard AE terms not used; specific AE terms not used for all AEs
|
|
Nervous system disorders
Non-operative site
|
1.3%
3/234 • Number of events 3 • This study requires that all operative site and serious systemic adverse events be reported from enrollment to 5 years postoperative. Censored protocol violations were not included as at risk participants.
Elective procedures not included.e.g.non-study joint replacement/revision,rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery. Industry standard AE terms not used; specific AE terms not used for all AEs
|
|
Renal and urinary disorders
Non-operative site
|
1.3%
3/234 • Number of events 3 • This study requires that all operative site and serious systemic adverse events be reported from enrollment to 5 years postoperative. Censored protocol violations were not included as at risk participants.
Elective procedures not included.e.g.non-study joint replacement/revision,rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery. Industry standard AE terms not used; specific AE terms not used for all AEs
|
|
Respiratory, thoracic and mediastinal disorders
Non-operative site
|
0.85%
2/234 • Number of events 2 • This study requires that all operative site and serious systemic adverse events be reported from enrollment to 5 years postoperative. Censored protocol violations were not included as at risk participants.
Elective procedures not included.e.g.non-study joint replacement/revision,rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery. Industry standard AE terms not used; specific AE terms not used for all AEs
|
|
Skin and subcutaneous tissue disorders
Non-operative site
|
0.43%
1/234 • Number of events 1 • This study requires that all operative site and serious systemic adverse events be reported from enrollment to 5 years postoperative. Censored protocol violations were not included as at risk participants.
Elective procedures not included.e.g.non-study joint replacement/revision,rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery. Industry standard AE terms not used; specific AE terms not used for all AEs
|
|
Vascular disorders
Non-operative site
|
2.6%
6/234 • Number of events 8 • This study requires that all operative site and serious systemic adverse events be reported from enrollment to 5 years postoperative. Censored protocol violations were not included as at risk participants.
Elective procedures not included.e.g.non-study joint replacement/revision,rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery. Industry standard AE terms not used; specific AE terms not used for all AEs
|
|
Nervous system disorders
Operative site
|
0.43%
1/234 • Number of events 1 • This study requires that all operative site and serious systemic adverse events be reported from enrollment to 5 years postoperative. Censored protocol violations were not included as at risk participants.
Elective procedures not included.e.g.non-study joint replacement/revision,rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery. Industry standard AE terms not used; specific AE terms not used for all AEs
|
|
Psychiatric disorders
Non-operative site
|
0.43%
1/234 • Number of events 1 • This study requires that all operative site and serious systemic adverse events be reported from enrollment to 5 years postoperative. Censored protocol violations were not included as at risk participants.
Elective procedures not included.e.g.non-study joint replacement/revision,rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery. Industry standard AE terms not used; specific AE terms not used for all AEs
|
Other adverse events
| Measure |
Accolade TMZF Hip Stem
n=234 participants at risk
Participants who received the Accolade TMZF Hip Stem
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Operative site Musculoskeletal and Connective tissue disorders
|
23.1%
54/234 • Number of events 63 • This study requires that all operative site and serious systemic adverse events be reported from enrollment to 5 years postoperative. Censored protocol violations were not included as at risk participants.
Elective procedures not included.e.g.non-study joint replacement/revision,rotator cuff repair,carpal tunnel release,cataract,intra-ocular \& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\& mid/flat-foot surgery. Industry standard AE terms not used; specific AE terms not used for all AEs
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Each investigator shall have privileges for their own center's results at the completion of the study. These manuscripts and abstracts will be delayed until after the multi-center publication is submitted.All publications shall be submitted to the sponsor for review at least 60 days prior to submission for publication.The sponsor shall not edit or otherwise influence the publications other than to ensure that confidential information is not disclosed and that the data is accurately represented.
- Publication restrictions are in place
Restriction type: OTHER