Trial Outcomes & Findings for ABC/Trident® Ceramic Post Approval Study (NCT NCT00960206)
NCT ID: NCT00960206
Last Updated: 2017-02-03
Results Overview
The number of hips in which the study device was removed and replaced with a new component/s is listed. Complications (adverse events) are listed in the adverse event section.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
413 participants
Primary outcome timeframe
10 years
Results posted on
2017-02-03
Participant Flow
There were 413/464 participants/hips enrolled. Started, completed and not completed counts are reported by hip.
Participant milestones
| Measure |
Trident® System
Hip received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
|
ABC System
Hip received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
|
Control
Hip received the Omnifit Acetabular system with polyethylene insert and metal femoral head.
|
|---|---|---|---|
|
Overall Study
STARTED
|
190
|
185
|
89
|
|
Overall Study
COMPLETED
|
150
|
158
|
77
|
|
Overall Study
NOT COMPLETED
|
40
|
27
|
12
|
Reasons for withdrawal
| Measure |
Trident® System
Hip received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
|
ABC System
Hip received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
|
Control
Hip received the Omnifit Acetabular system with polyethylene insert and metal femoral head.
|
|---|---|---|---|
|
Overall Study
Death
|
7
|
4
|
1
|
|
Overall Study
Unwilling/Unable to return
|
1
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
8
|
14
|
8
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
0
|
|
Overall Study
Revision of study component
|
2
|
2
|
2
|
|
Overall Study
Missing 10 year data
|
20
|
1
|
1
|
Baseline Characteristics
ABC/Trident® Ceramic Post Approval Study
Baseline characteristics by cohort
| Measure |
Trident System
n=190 Participants
Trident Ceramic Insert/Trident AD with PureFix HA Shell
|
ABC System
n=185 Participants
Howmedica Osteonics Alumina Insert/either PSL Microstructured or Secur Fit HA PSL Shell
|
Control
n=89 Participants
Howmedica Osteonics Omnifit Series II Cup Inserts/Omnifit PSL Microstructured Shell
|
Total
n=464 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.5 years
n=5 Participants
|
53.9 years
n=7 Participants
|
54.7 years
n=5 Participants
|
53.08 years
n=4 Participants
|
|
Sex/Gender, Customized
Female
|
67 hips
n=5 Participants
|
64 hips
n=7 Participants
|
35 hips
n=5 Participants
|
166 hips
n=4 Participants
|
|
Sex/Gender, Customized
Male
|
123 hips
n=5 Participants
|
121 hips
n=7 Participants
|
54 hips
n=5 Participants
|
298 hips
n=4 Participants
|
|
Region of Enrollment
United States
|
190 hips
n=5 Participants
|
185 hips
n=7 Participants
|
89 hips
n=5 Participants
|
464 hips
n=4 Participants
|
PRIMARY outcome
Timeframe: 10 yearsPopulation: Number of participants analyzed includes all subjects enrolled.
The number of hips in which the study device was removed and replaced with a new component/s is listed. Complications (adverse events) are listed in the adverse event section.
Outcome measures
| Measure |
Trident® System
n=190 hips
Hip received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
|
ABC System
n=185 hips
Hip received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
|
Control
n=89 hips
Hip recevied the Omnifit Acetabular system with polyethylene insert and metal femoral head.
|
|---|---|---|---|
|
Component Revision and Complications
|
2 hips
|
2 hips
|
2 hips
|
SECONDARY outcome
Timeframe: 3-5 and 10 YearsPopulation: Participants may have one or both hips replaced. Number of participants and hips analyzed include all enrolled. Number of hips with HHS evaluated at postoperative periods indicated is included in the outcome results posting.
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® System
n=190 Hips
Hip received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
|
ABC System
n=185 Hips
Hip received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
|
Control
n=89 Hips
Hip recevied the Omnifit Acetabular system with polyethylene insert and metal femoral head.
|
|---|---|---|---|
|
Harris Hip Score
3 yr hips with good-excellent score (80-100)
|
160 hips
|
171 hips
|
81 hips
|
|
Harris Hip Score
3 yr hips with a fair-poor score (0-79)
|
2 hips
|
2 hips
|
2 hips
|
|
Harris Hip Score
4 yr hips with a good-excellent score (80-100)
|
148 hips
|
164 hips
|
77 hips
|
|
Harris Hip Score
4 yr hips with a fair-poor score (0-79)
|
6 hips
|
2 hips
|
2 hips
|
|
Harris Hip Score
5 yr hips with a good-excellent score (80-100)
|
126 hips
|
158 hips
|
76 hips
|
|
Harris Hip Score
5 yr hips with a fair-poor score (0-79)
|
6 hips
|
4 hips
|
2 hips
|
|
Harris Hip Score
10 yr hips with a good-excellent score (80-100)
|
67 hips
|
115 hips
|
56 hips
|
|
Harris Hip Score
10 yr hips with a fair-poor score (0-79)
|
0 hips
|
4 hips
|
2 hips
|
SECONDARY outcome
Timeframe: 3-5 and 10 yearsPopulation: Participants may have one or both hips replaced. Number of participants/hips analyzed includes all enrolled. Number of hips demonstrating radiographic failure assessment at postoperative periods indicated is included in the outcome results posting. Number of hips available for evaluation is indicated in the results heading by postoperative period.
Failure is defined as progressive femoral radiolucency (RLL) \> or = 2mm around entire stem, progressive subsidence \> or = 5mm, progressive acetabular radiolucency (RLL) \> or = 2 mm around entire cup, or cup migration \> or = 3mm.
Outcome measures
| Measure |
Trident® System
n=190 Hips
Hip received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
|
ABC System
n=185 Hips
Hip received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
|
Control
n=89 Hips
Hip recevied the Omnifit Acetabular system with polyethylene insert and metal femoral head.
|
|---|---|---|---|
|
Radiographic Evaluation
3 yr failure (160 Trident®/174 ABC/82 Control)
|
0 hips
|
0 hips
|
0 hips
|
|
Radiographic Evaluation
4 yr failure (153 Trident®/162 ABC/79 Control)
|
0 hips
|
0 hips
|
0 hips
|
|
Radiographic Evaluation
5 yr failure (128 Trident®/158 ABC/74 Control)
|
0 hips
|
0 hips
|
0 hips
|
|
Radiographic Evaluation
10 yr failure (60 Trident®/116 ABC/56 Control)
|
0 hips
|
0 hips
|
0 hips
|
SECONDARY outcome
Timeframe: 6-10 yearsPopulation: Participants may have one or both hips replaced. Number of participants/hips analyzed includes all enrolled. Number of hips with positive three question responses at postoperative periods indicated is included in the outcome results posting. Number of hips available for evaluation is indicated in the results heading by postoperative period.
A three question follow-up questionnaire was administered annually asking whether the participant is satisfied with the study total hip replacement(THR) (noted as "satisfied" below); whether they have any study hip pain (noted as "no pain" below); and whether they have had any surgery on the study hip during the previous year noted as "no surgery" below).
Outcome measures
| Measure |
Trident® System
n=190 Hips
Hip received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
|
ABC System
n=185 Hips
Hip received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
|
Control
n=89 Hips
Hip recevied the Omnifit Acetabular system with polyethylene insert and metal femoral head.
|
|---|---|---|---|
|
Hip Follow-Up Questionnaire
6yr satisfied (Trident ®168/ABC 150/Control 79)
|
163 hips
|
146 hips
|
76 hips
|
|
Hip Follow-Up Questionnaire
6yr no pain (Trident ®168/ABC 150/Control 79)
|
142 hips
|
129 hips
|
63 hips
|
|
Hip Follow-Up Questionnaire
6yr no surgery (Trident ®168/ABC 150/Control 79)
|
168 hips
|
147 hips
|
79 hips
|
|
Hip Follow-Up Questionnaire
7yr satisfied (Trident ®166/ABC 146/Control 71)
|
161 hips
|
145 hips
|
71 hips
|
|
Hip Follow-Up Questionnaire
7 yr no pain (Trident ®166/ABC 146/Control 71)
|
138 hips
|
130 hips
|
58 hips
|
|
Hip Follow-Up Questionnaire
7 yr no surgery (Trident® 166/ABC 146/Control 71)
|
165 hips
|
145 hips
|
71 hips
|
|
Hip Follow-Up Questionnaire
8yr satisfied (Trident ®164/ABC 141/Control 75)
|
160 hips
|
141 hips
|
73 hips
|
|
Hip Follow-Up Questionnaire
8yr no pain (Trident ®164/ABC 141/Control 75)
|
140 hips
|
127 hips
|
68 hips
|
|
Hip Follow-Up Questionnaire
8yr no surgery (Trident ®164/ABC 141/Control 75)
|
164 hips
|
141 hips
|
75 hips
|
|
Hip Follow-Up Questionnaire
9yr satisfied (Trident ®150/ABC 162/Control 83)
|
148 hips
|
161 hips
|
83 hips
|
|
Hip Follow-Up Questionnaire
9yr no pain (Trident ®150/ABC 162/Control 83)
|
128 hips
|
150 hips
|
73 hips
|
|
Hip Follow-Up Questionnaire
9yr no surgery (Trident ®150/ABC 162/Control 83)
|
150 hips
|
162 hips
|
83 hips
|
|
Hip Follow-Up Questionnaire
10yr satisfied (Trident ®143/ABC 148/Control 76)
|
142 hips
|
148 hips
|
76 hips
|
|
Hip Follow-Up Questionnaire
10yr no pain (Trident ®143/ABC 148/Control 76)
|
123 hips
|
136 hips
|
65 hips
|
|
Hip Follow-Up Questionnaire
10yr no surgery (Trident ®143/ABC 148/Control 76)
|
143 hips
|
148 hips
|
76 hips
|
Adverse Events
Trident® System
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
ABC System
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Control
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
All Participants
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Trident® System
n=190 participants at risk
Hips that received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
|
ABC System
n=185 participants at risk
Hips that received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
|
Control
n=89 participants at risk
Hips that received the Omnifit Acetabular system with polyethylene insert and metal femoral head.
|
All Participants
n=413 participants at risk
All participants combined.
|
|---|---|---|---|---|
|
Cardiac disorders
Non-operative Site Cardiac Disorders
|
—
0/0 • 10 years
Some participants were randomized to more than one hip system (17 participants/34 hips). Operative Site adverse events are reported by hip; systemic events are reported by participant. There were a total of 413 participants with 464 hips (190 Trident,185 ABC,89 Control) assessed.
|
—
0/0 • 10 years
Some participants were randomized to more than one hip system (17 participants/34 hips). Operative Site adverse events are reported by hip; systemic events are reported by participant. There were a total of 413 participants with 464 hips (190 Trident,185 ABC,89 Control) assessed.
|
—
0/0 • 10 years
Some participants were randomized to more than one hip system (17 participants/34 hips). Operative Site adverse events are reported by hip; systemic events are reported by participant. There were a total of 413 participants with 464 hips (190 Trident,185 ABC,89 Control) assessed.
|
0.24%
1/413 • Number of events 1 • 10 years
Some participants were randomized to more than one hip system (17 participants/34 hips). Operative Site adverse events are reported by hip; systemic events are reported by participant. There were a total of 413 participants with 464 hips (190 Trident,185 ABC,89 Control) assessed.
|
|
Musculoskeletal and connective tissue disorders
Operative Site Musculoskeletal and Connective Tissue Disorder
|
0.53%
1/190 • Number of events 1 • 10 years
Some participants were randomized to more than one hip system (17 participants/34 hips). Operative Site adverse events are reported by hip; systemic events are reported by participant. There were a total of 413 participants with 464 hips (190 Trident,185 ABC,89 Control) assessed.
|
0.54%
1/185 • Number of events 1 • 10 years
Some participants were randomized to more than one hip system (17 participants/34 hips). Operative Site adverse events are reported by hip; systemic events are reported by participant. There were a total of 413 participants with 464 hips (190 Trident,185 ABC,89 Control) assessed.
|
1.1%
1/89 • Number of events 1 • 10 years
Some participants were randomized to more than one hip system (17 participants/34 hips). Operative Site adverse events are reported by hip; systemic events are reported by participant. There were a total of 413 participants with 464 hips (190 Trident,185 ABC,89 Control) assessed.
|
—
0/0 • 10 years
Some participants were randomized to more than one hip system (17 participants/34 hips). Operative Site adverse events are reported by hip; systemic events are reported by participant. There were a total of 413 participants with 464 hips (190 Trident,185 ABC,89 Control) assessed.
|
Other adverse events
| Measure |
Trident® System
n=190 participants at risk
Hips that received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
|
ABC System
n=185 participants at risk
Hips that received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
|
Control
n=89 participants at risk
Hips that received the Omnifit Acetabular system with polyethylene insert and metal femoral head.
|
All Participants
n=413 participants at risk
All participants combined.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Operative Site Musculoskeletal and Connective Tissue Disorder
|
18.9%
36/190 • Number of events 48 • 10 years
Some participants were randomized to more than one hip system (17 participants/34 hips). Operative Site adverse events are reported by hip; systemic events are reported by participant. There were a total of 413 participants with 464 hips (190 Trident,185 ABC,89 Control) assessed.
|
9.2%
17/185 • Number of events 17 • 10 years
Some participants were randomized to more than one hip system (17 participants/34 hips). Operative Site adverse events are reported by hip; systemic events are reported by participant. There were a total of 413 participants with 464 hips (190 Trident,185 ABC,89 Control) assessed.
|
7.9%
7/89 • Number of events 8 • 10 years
Some participants were randomized to more than one hip system (17 participants/34 hips). Operative Site adverse events are reported by hip; systemic events are reported by participant. There were a total of 413 participants with 464 hips (190 Trident,185 ABC,89 Control) assessed.
|
—
0/0 • 10 years
Some participants were randomized to more than one hip system (17 participants/34 hips). Operative Site adverse events are reported by hip; systemic events are reported by participant. There were a total of 413 participants with 464 hips (190 Trident,185 ABC,89 Control) assessed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The disclosure restriction on the PI to publish results of this Clinical Study or the results of the activities hereunder, any abstract, manuscript, presentation or other communication shall be submitted to sponsor for review and approval at least 60 days prior to submission for publication. The sponsor retains the right to deny publication or, at its sole option, to revise the manuscript to delete proprietary or other confidential commercial information.
- Publication restrictions are in place
Restriction type: OTHER