Trial Outcomes & Findings for Trident® X3 Polyethylene Insert Study (NCT NCT00958191)
NCT ID: NCT00958191
Last Updated: 2018-02-23
Results Overview
Linear wear rates are defined as the annual rate of removal of the polyethylene from the polyethylene insert determined by comparing digitized images of serial radiographs obtained over the follow-up period of 5 years
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
250 participants
Primary outcome timeframe
5 years
Results posted on
2018-02-23
Participant Flow
For bilateral hip replacement participants, if one hip completed primary endpoint #1 the participant is counted as completed. If one hip was censored, but the other hip was not, the hip is counted as censored, but the participant is not.
250 participants/271 hips enrolled - 29 participants/31 hips censored= 221 participants/240 hips followed. There were 5 revisions, but one bilateral participant had one hip revised and the other hip completed the primary endpoint. This participant is counted as completed and not in the revision category.
Unit of analysis: hips
Participant milestones
| Measure |
Trident® X3 Polyethylene Insert
Participants who received the Trident X3 polyetheylene insert can have one or both hips replaced. If both hips were replaced, but one hip completed the primary endpoint, the participant is counted as completed.
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|---|---|
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Overall Study
STARTED
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221 240
|
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Overall Study
COMPLETED
|
110 118
|
|
Overall Study
NOT COMPLETED
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111 122
|
Reasons for withdrawal
| Measure |
Trident® X3 Polyethylene Insert
Participants who received the Trident X3 polyetheylene insert can have one or both hips replaced. If both hips were replaced, but one hip completed the primary endpoint, the participant is counted as completed.
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|---|---|
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Overall Study
Death
|
4
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Inadequate 5 yr x-ray quality
|
10
|
|
Overall Study
Unable/Unwilling to Return/Withdrawal
|
21
|
|
Overall Study
Revision of study device
|
4
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|
Overall Study
Site termination
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11
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Overall Study
No 5 yr x-rays
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56
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Baseline Characteristics
Trident® X3 Polyethylene Insert Study
Baseline characteristics by cohort
| Measure |
Trident® X3 Polyethylene Insert
n=221 Participants
All subjects who recieved the Trident X3 insert.
|
|---|---|
|
Age, Continuous
|
62.04 years
STANDARD_DEVIATION 8.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
105 Participants
n=5 Participants
|
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Region of Enrollment
United States
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221 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsLinear wear rates are defined as the annual rate of removal of the polyethylene from the polyethylene insert determined by comparing digitized images of serial radiographs obtained over the follow-up period of 5 years
Outcome measures
| Measure |
Trident® X3 Polyethylene Insert
n=118 Hips
Participants who received theTrident® X3 Polyethylene Insert
|
|---|---|
|
Mean Linear Wear Rate at 5 Years
|
0.016 mm/year
Standard Deviation 0.068
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PRIMARY outcome
Timeframe: 5 yearPopulation: Difference of 5 participants from the participant flow completed (=110): 4 participants are included in the revision category of the participant flow and one participant had revision of only the femoral head \& stem but later withdrew from the study \& is included in the withdrawal category of the participant flow.
Revision of any component is defined as surgical removal and replacement of the femoral component, acetabular shell, acetabular insert and/or femoral head.
Outcome measures
| Measure |
Trident® X3 Polyethylene Insert
n=124 Hips
Participants who received theTrident® X3 Polyethylene Insert
|
|---|---|
|
Rate of Incidence of Revision of Component for Any Reason
|
4.84 percentage of hips undergoing revision
|
SECONDARY outcome
Timeframe: 2, 3 and 4 year films collected; 3 and 4 year wear assessedPopulation: Participants/hips with available data. Overall number of participants and units analyzed is based upon the 3 year population.
Linear wear rates are defined as the annual rate of removal of the polyethylene from the polyethylene insert determined by comparing digitized images of serial radiographs obtained over the follow-up period. NOTE: 2 year linear and volumetric wear was not calculated for the following reason: To determine polyethylene wear, the total femoral head penetration is first calculated from the radiographs.The femoral head penetration has two components namely wear and creep (or bedding-in). It is not possible to separate the total penetration in to two components. The creep of the polyethylene starts from the date of surgery and continues up to 12-24 months. Therefore, the head penetration value at 2-years is dominated by Creep rather than wear.
Outcome measures
| Measure |
Trident® X3 Polyethylene Insert
n=149 Hips
Participants who received theTrident® X3 Polyethylene Insert
|
|---|---|
|
Linear Wear Rate of the Trident X3 Polyethylene Insert
3 year mean wear rate
|
0.022 mm/year
Standard Deviation 0.133
|
|
Linear Wear Rate of the Trident X3 Polyethylene Insert
4 year mean wear rate
|
0.024 mm/year
Standard Deviation 0.087
|
SECONDARY outcome
Timeframe: 2, 3, 4 and 5 year films collected; 3, 4 and 5 year wear assessedPopulation: Participants/hips with available data. Overall number of participants and units analyzed is based upon the 3 year population.
Volumetric wear rate is calculated using a formula based on the cylindrical wear pattern perpendicular to the face of the cup and the mean linear wear rate. NOTE: 2 year linear and volumetric wear was not calculated for the following reason: To determine polyethylene wear, the total femoral head penetration is first calculated from the radiographs.The femoral head penetration has two components namely wear and creep (or bedding-in). It is not possible to separate the total penetration in to two components. The creep of the polyethylene starts from the date of surgery and continues up to 12-24 months. Therefore, the head penetration value at 2-years is dominated by Creep rather than wear.
Outcome measures
| Measure |
Trident® X3 Polyethylene Insert
n=149 Hips
Participants who received theTrident® X3 Polyethylene Insert
|
|---|---|
|
Volumetric Wear Rate of the Trident X3 Polyethylene Insert
3 year volumetric wear rate
|
17.9 cubic mm/year
|
|
Volumetric Wear Rate of the Trident X3 Polyethylene Insert
4 year volumetric wear rate
|
19.1 cubic mm/year
|
|
Volumetric Wear Rate of the Trident X3 Polyethylene Insert
5 year volumetric wear rate
|
13.3 cubic mm/year
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SECONDARY outcome
Timeframe: 1,2,3,4 and 5 yearsPopulation: Participants/hips with available data. Overall number of participants and units analyzed is based upon the 1 year population.
Radiographic stability is defined as having all of the following: no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire acetabular cup, no radiographic indication of acetabular cup migration of greater than or equal to 3 mm, no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire femoral component, and no radiographic indication of progressive subsidence of the femoral component of greater than or equal to 5 mm. Radiographs are evaluated at 1,2,3,4 and 5 years.
Outcome measures
| Measure |
Trident® X3 Polyethylene Insert
n=214 Hips
Participants who received theTrident® X3 Polyethylene Insert
|
|---|---|
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Radiographic Stability
Radiographically unstable at 1 year
|
0 hips evaluated as unstable on radiograph
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Radiographic Stability
Radiographically unstable at 2 years
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0 hips evaluated as unstable on radiograph
|
|
Radiographic Stability
Radiographically unstable at 3 years
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0 hips evaluated as unstable on radiograph
|
|
Radiographic Stability
Radiographically unstable at 4 years
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0 hips evaluated as unstable on radiograph
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Radiographic Stability
Radiographically unstable at 5 years
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0 hips evaluated as unstable on radiograph
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SECONDARY outcome
Timeframe: pre-operative, 1,3 and 5 yearsPopulation: Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.
The change in HHS is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative scores that assess pain, function, joint deformity and range of motion. 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 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 |
Trident® X3 Polyethylene Insert
n=236 Hips
Participants who received theTrident® X3 Polyethylene Insert
|
|---|---|
|
Mean Harris Hip Score (HHS) to Assess Change
HHS Mean 1 Year Score
|
94.41 units on a scale
Standard Deviation 8.75
|
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Mean Harris Hip Score (HHS) to Assess Change
HHS Mean Preoperative Score
|
53.01 units on a scale
Standard Deviation 13.68
|
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Mean Harris Hip Score (HHS) to Assess Change
HHS Mean 3 Year Score
|
95.32 units on a scale
Standard Deviation 8.32
|
|
Mean Harris Hip Score (HHS) to Assess Change
HHS Mean 5 year Score
|
94.05 units on a scale
Standard Deviation 8.70
|
SECONDARY outcome
Timeframe: pre-operative, 1,3, and 5 yearsPopulation: Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.
The change in HHS Pain is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative pain scores. Scores can range from 0 to 44, with 0 indicating totally disabling pain and 44 indicating no pain or pain that is ignored. * None or ignores it = 44 points * Slight, occasional, no compromise in activities = 40 points * Mild pain, no effect on average activities, rarely moderate pain with unusual activity;may take aspirin = 30 points * Moderate pain, tolerable, but makes concessions to pain. Some limitation of ordinary activity or work. May require occasional pain medication stronger than aspirin = 20 points * Marked pain, serious limitation of activites = 10 points * Totally disabled, crippled, pain in bed, bedridden = 0 points
Outcome measures
| Measure |
Trident® X3 Polyethylene Insert
n=240 Hips
Participants who received theTrident® X3 Polyethylene Insert
|
|---|---|
|
Mean Harris Hip Score (HHS) Pain Score to Assess Change
HHS Pain Mean 1 Year Score
|
41.52 units on a scale
Standard Deviation 5.64
|
|
Mean Harris Hip Score (HHS) Pain Score to Assess Change
HHS Pain Mean 3 Year Score
|
42.50 units on a scale
Standard Deviation 4.89
|
|
Mean Harris Hip Score (HHS) Pain Score to Assess Change
HHS Pain Mean 5 Year Score
|
41.75 units on a scale
Standard Deviation 5.99
|
|
Mean Harris Hip Score (HHS) Pain Score to Assess Change
HHS Pain Mean Preoperative Score
|
16.73 units on a scale
Standard Deviation 8.24
|
SECONDARY outcome
Timeframe: pre-operative, 1,3 and 5 yearsPopulation: Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.
The change in HHS ROM is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative scores. Scores can range from 0 (worst) to 5 (best). The degrees of motion are measured for hip flexion, abduction, adduction, external rotation and internal rotation. The measured values are added to determine a combined value that is associated with a score from 0 to 5. * 211-300 degrees = 5 points * 161 to 210 degrees = 4 points * 101 to 160 degrees = 3 points * 61 to 100 degrees = 2 points * 31 to 60 degrees = 1 points * 0 to 30 degrees = 0 points
Outcome measures
| Measure |
Trident® X3 Polyethylene Insert
n=240 Hips
Participants who received theTrident® X3 Polyethylene Insert
|
|---|---|
|
Mean Harris Hip Score (HHS) Range of Motion (ROM) Score to Assess Change
HHS ROM Mean Preoperative Score
|
3.90 units on a scale
Standard Deviation 0.95
|
|
Mean Harris Hip Score (HHS) Range of Motion (ROM) Score to Assess Change
HHS ROM Mean 1 Year Score
|
4.99 units on a scale
Standard Deviation 0.12
|
|
Mean Harris Hip Score (HHS) Range of Motion (ROM) Score to Assess Change
HHS ROM Mean 3 Year Score
|
4.99 units on a scale
Standard Deviation 0.11
|
|
Mean Harris Hip Score (HHS) Range of Motion (ROM) Score to Assess Change
HHS ROM Mean 5 Year Score
|
4.93 units on a scale
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: pre-operative, 1,3 and 5 yearsPopulation: Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.
Change in the SF-12 score is reported by comparing the mean preoperative, 1,3 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 |
Trident® X3 Polyethylene Insert
n=233 Hips
Participants who received theTrident® X3 Polyethylene Insert
|
|---|---|
|
Mean SF-12 Health Survey Score to Assess Change
Mean SF-12 Mental Score Preoperative
|
53.75 units on a scale
Standard Deviation 10.91
|
|
Mean SF-12 Health Survey Score to Assess Change
Mean SF-12 Mental Score 1 year
|
55.72 units on a scale
Standard Deviation 7.83
|
|
Mean SF-12 Health Survey Score to Assess Change
Mean SF-12 Mental Score 3 years
|
55.78 units on a scale
Standard Deviation 8.13
|
|
Mean SF-12 Health Survey Score to Assess Change
Mean SF-12 Mental Score 5 years
|
54.88 units on a scale
Standard Deviation 7.76
|
|
Mean SF-12 Health Survey Score to Assess Change
Mean SF-12 Physical Score Preoperative
|
32.11 units on a scale
Standard Deviation 8.86
|
|
Mean SF-12 Health Survey Score to Assess Change
Mean SF-12 Physical Score 1 year
|
49.90 units on a scale
Standard Deviation 8.51
|
|
Mean SF-12 Health Survey Score to Assess Change
Mean SF-12 Physical Score 3 years
|
49.97 units on a scale
Standard Deviation 8.74
|
|
Mean SF-12 Health Survey Score to Assess Change
Mean SF-12 Physical Score 5 years
|
49.08 units on a scale
Standard Deviation 8.38
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SECONDARY outcome
Timeframe: pre-operative, 1,3 and 5 yearsPopulation: Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.
Change in the LEAS is reported by comparing the mean preoperative, 1,3 and 5 year scores. The LEAS is completed by the participant to assess activity level. Activity levels are ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.
Outcome measures
| Measure |
Trident® X3 Polyethylene Insert
n=240 Hips
Participants who received theTrident® X3 Polyethylene Insert
|
|---|---|
|
Mean Lower Extremity Activity Scale (LEAS) Score to Assess Change
Mean LEAS score Preoperative
|
8.95 units on a scale
Standard Deviation 2.54
|
|
Mean Lower Extremity Activity Scale (LEAS) Score to Assess Change
Mean LEAS score 1 year
|
11.65 units on a scale
Standard Deviation 3.01
|
|
Mean Lower Extremity Activity Scale (LEAS) Score to Assess Change
Mean LEAS score 3 years
|
11.69 units on a scale
Standard Deviation 2.95
|
|
Mean Lower Extremity Activity Scale (LEAS) Score to Assess Change
Mean LEAS score 5 years
|
10.92 units on a scale
Standard Deviation 2.92
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SECONDARY outcome
Timeframe: 10 yearsPopulation: Participants with available data. The population includes all 240 cases who were initially consented to 5 year study. There are 127 cases who consented to continue in the 10 year study.
Implant survivorship is determined using the Kaplan-Meier method.
Outcome measures
| Measure |
Trident® X3 Polyethylene Insert
n=240 hips
Participants who received theTrident® X3 Polyethylene Insert
|
|---|---|
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Implant Survivorship
Kaplan-Meier Estimate (based on 5 year cases)
|
95.79 percentage of hips
|
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Implant Survivorship
Kaplan-Meier Estimate (based on 10 year cases)
|
98.37 percentage of hips
|
Adverse Events
Operative Adverse Events
Serious events: 12 serious events
Other events: 62 other events
Deaths: 0 deaths
Non-operative Adverse Events
Serious events: 33 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Operative Adverse Events
n=240 participants at risk
Trident X3 Polyethylene Insert. Operative site events are reported by hip because in the case of bilateral participants (this is when one participant has both hips enrolled in the study), an event can occur in one hip, both hips or the same hip at different times and are counted separately for this reason.
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Non-operative Adverse Events
n=221 participants at risk
Trident X3 Polyethylene Insert. Non-operative site events are reported by participant.
|
|---|---|---|
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Cardiac disorders
Non-operative Site
|
—
0/0 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
1.4%
3/221 • Number of events 3 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
|
Gastrointestinal disorders
Non-operative Site
|
—
0/0 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
0.45%
1/221 • Number of events 1 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
|
General disorders
Non-operative Site
|
—
0/0 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
0.45%
1/221 • Number of events 1 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
|
Hepatobiliary disorders
Non-operative Site
|
—
0/0 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
0.45%
1/221 • Number of events 1 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
|
Infections and infestations
Operative Site
|
0.42%
1/240 • Number of events 1 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
—
0/0 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
|
Infections and infestations
Non-operative Site
|
—
0/0 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
1.8%
4/221 • Number of events 4 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
|
Injury, poisoning and procedural complications
Operative Site
|
0.42%
1/240 • Number of events 1 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
—
0/0 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
|
Musculoskeletal and connective tissue disorders
Operative Site
|
4.6%
11/240 • Number of events 19 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
—
0/0 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
|
Musculoskeletal and connective tissue disorders
Non-operative Site
|
—
0/0 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
5.9%
13/221 • Number of events 14 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-operative Site
|
—
0/0 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
1.8%
4/221 • Number of events 4 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
|
Nervous system disorders
Operative Site
|
0.42%
1/240 • Number of events 1 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
—
0/0 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
|
Nervous system disorders
Non-operative Site
|
—
0/0 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
0.45%
1/221 • Number of events 1 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
|
Psychiatric disorders
Non-operative Site
|
—
0/0 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
0.45%
1/221 • Number of events 1 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
|
Renal and urinary disorders
Non-operative Site
|
—
0/0 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
1.4%
3/221 • Number of events 3 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Non-operative Site
|
—
0/0 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
0.45%
1/221 • Number of events 1 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
|
Vascular disorders
Non-operative Site
|
—
0/0 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
0.90%
2/221 • Number of events 2 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
Other adverse events
| Measure |
Operative Adverse Events
n=240 participants at risk
Trident X3 Polyethylene Insert. Operative site events are reported by hip because in the case of bilateral participants (this is when one participant has both hips enrolled in the study), an event can occur in one hip, both hips or the same hip at different times and are counted separately for this reason.
|
Non-operative Adverse Events
n=221 participants at risk
Trident X3 Polyethylene Insert. Non-operative site events are reported by participant.
|
|---|---|---|
|
Blood and lymphatic system disorders
Non-operative Site
|
—
0/0 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
7.7%
17/221 • Number of events 17 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
|
Infections and infestations
Non-operative Site
|
—
0/0 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
5.9%
13/221 • Number of events 15 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
|
Injury, poisoning and procedural complications
Operative Site
|
7.9%
19/240 • Number of events 19 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
—
0/0 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
|
Musculoskeletal and connective tissue disorders
Operative Site
|
18.8%
45/240 • Number of events 55 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
—
0/0 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
|
Musculoskeletal and connective tissue disorders
Non-operative Site
|
—
0/0 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
18.6%
41/221 • Number of events 50 • To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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-foot/flat-foot surgery.
|
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