Trial Outcomes & Findings for Trilogy AB Acetabular Hip System Post Approval Study (NCT NCT00715026)
NCT ID: NCT00715026
Last Updated: 2014-11-26
Results Overview
The Harris Hip Score was developed to assess hip disabilities and methods of treatment and has been in use for decades. It evaluates patients on the basis of pain, function, absence of deformity and range of motion. The Harris Hip Score could range from 0 to 100. Scores less then 70 are poor, scores 70 to 79 are fair, scores 80 to 89 are good, and scores 90 to 100 are excellent.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
31 participants
Primary outcome timeframe
Pre-op, 3 Month Post-Op and Annual Post-Op visits through 5 Years
Results posted on
2014-11-26
Participant Flow
Participant milestones
| Measure |
Trilogy AB Acetabular Hip Implant System
Post Approval Study of Device.
Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces.
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
Subjects That Received Surgery
|
25
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Trilogy AB Acetabular Hip Implant System
Post Approval Study of Device.
Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Surgery done on non-study consented hip
|
1
|
Baseline Characteristics
Trilogy AB Acetabular Hip System Post Approval Study
Baseline characteristics by cohort
| Measure |
Trilogy AB Acetabular Hip Implant System
n=25 Participants
Post Approval Study of Device.
Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces.
|
|---|---|
|
Age, Continuous
|
58 Years
STANDARD_DEVIATION 14 • n=93 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Pre-op, 3 Month Post-Op and Annual Post-Op visits through 5 YearsPopulation: Data was received on 24 subjects/25 hips at preop, on 17 subjects/18 hips at 3 months, and on 4 subjects at 1 year prior to the early termination of the study. Each hip, whether unilateral or bilateral, was counted separately. Early study termination was done due to voluntary removal of the device from the US market.
The Harris Hip Score was developed to assess hip disabilities and methods of treatment and has been in use for decades. It evaluates patients on the basis of pain, function, absence of deformity and range of motion. The Harris Hip Score could range from 0 to 100. Scores less then 70 are poor, scores 70 to 79 are fair, scores 80 to 89 are good, and scores 90 to 100 are excellent.
Outcome measures
| Measure |
Trilogy AB Acetabular Hip Implant System
n=24 Participants
Post Approval Study of Device.
Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces.
|
|---|---|
|
Harris Hip Score
Preop Harris Hip Scores
|
52.7 units on a scale
Standard Deviation 11.6
|
|
Harris Hip Score
3 Months Harris Hip Score
|
68.2 units on a scale
Standard Deviation 16.11
|
|
Harris Hip Score
1 Year Harris Hip Scores
|
70 units on a scale
Standard Deviation 19.54
|
SECONDARY outcome
Timeframe: At all follow-up visits through 5 Years and postcard follow-up 6 - 10 YearsA total of 37 Adverse Events were reported. There have been no UADEs reported in this study population. At the time of site closure all AEs were resolved or tolerated. Implant survivorship not reportable due to early study termination.
Outcome measures
| Measure |
Trilogy AB Acetabular Hip Implant System
n=25 Participants
Post Approval Study of Device.
Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces.
|
|---|---|
|
Continued Assessment of Implant Survivorship and Incidences of Adverse Events.
SAEs - Not device related
|
11 adverse events
|
|
Continued Assessment of Implant Survivorship and Incidences of Adverse Events.
AEs - Not device related
|
21 adverse events
|
|
Continued Assessment of Implant Survivorship and Incidences of Adverse Events.
AEs - Definitely device related
|
3 adverse events
|
|
Continued Assessment of Implant Survivorship and Incidences of Adverse Events.
AEs - Uncertain relation to device
|
2 adverse events
|
Adverse Events
Trilogy AB Acetabular Hip Implant System
Serious events: 6 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Trilogy AB Acetabular Hip Implant System
n=25 participants at risk
Post Approval Study of Device.
Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces.
|
|---|---|
|
Cardiac disorders
Cardiac Arrhythmia
|
4.0%
1/25 • Number of events 1
Of the Serious Adverse Events, all were not related to the device. Of the other Adverse Events 3 were related to device and 2 were uncertain in relation.
|
|
General disorders
Other/General
|
8.0%
2/25 • Number of events 2
Of the Serious Adverse Events, all were not related to the device. Of the other Adverse Events 3 were related to device and 2 were uncertain in relation.
|
|
Cardiac disorders
Congestive Heart Failure
|
4.0%
1/25 • Number of events 1
Of the Serious Adverse Events, all were not related to the device. Of the other Adverse Events 3 were related to device and 2 were uncertain in relation.
|
|
Musculoskeletal and connective tissue disorders
Contralateral Hip Replacement
|
4.0%
1/25 • Number of events 1
Of the Serious Adverse Events, all were not related to the device. Of the other Adverse Events 3 were related to device and 2 were uncertain in relation.
|
|
Blood and lymphatic system disorders
Anemia
|
8.0%
2/25 • Number of events 2
Of the Serious Adverse Events, all were not related to the device. Of the other Adverse Events 3 were related to device and 2 were uncertain in relation.
|
|
Gastrointestinal disorders
GI Bleed
|
4.0%
1/25 • Number of events 1
Of the Serious Adverse Events, all were not related to the device. Of the other Adverse Events 3 were related to device and 2 were uncertain in relation.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure/Pneumonia
|
8.0%
2/25 • Number of events 2
Of the Serious Adverse Events, all were not related to the device. Of the other Adverse Events 3 were related to device and 2 were uncertain in relation.
|
|
Renal and urinary disorders
Pre-Renal Azotemia
|
4.0%
1/25 • Number of events 1
Of the Serious Adverse Events, all were not related to the device. Of the other Adverse Events 3 were related to device and 2 were uncertain in relation.
|
Other adverse events
| Measure |
Trilogy AB Acetabular Hip Implant System
n=25 participants at risk
Post Approval Study of Device.
Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash/Skin Lesions
|
4.0%
1/25 • Number of events 2
Of the Serious Adverse Events, all were not related to the device. Of the other Adverse Events 3 were related to device and 2 were uncertain in relation.
|
|
Infections and infestations
Infection/Fever/Drainage
|
8.0%
2/25 • Number of events 4
Of the Serious Adverse Events, all were not related to the device. Of the other Adverse Events 3 were related to device and 2 were uncertain in relation.
|
|
Injury, poisoning and procedural complications
Fall
|
4.0%
1/25 • Number of events 1
Of the Serious Adverse Events, all were not related to the device. Of the other Adverse Events 3 were related to device and 2 were uncertain in relation.
|
|
Renal and urinary disorders
Hematuria
|
4.0%
1/25 • Number of events 1
Of the Serious Adverse Events, all were not related to the device. Of the other Adverse Events 3 were related to device and 2 were uncertain in relation.
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.0%
1/25 • Number of events 1
Of the Serious Adverse Events, all were not related to the device. Of the other Adverse Events 3 were related to device and 2 were uncertain in relation.
|
|
Musculoskeletal and connective tissue disorders
Thigh/Hip/Groin Pain
|
8.0%
2/25 • Number of events 2
Of the Serious Adverse Events, all were not related to the device. Of the other Adverse Events 3 were related to device and 2 were uncertain in relation.
|
|
Musculoskeletal and connective tissue disorders
Femur Fracture
|
12.0%
3/25 • Number of events 3
Of the Serious Adverse Events, all were not related to the device. Of the other Adverse Events 3 were related to device and 2 were uncertain in relation.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
4.0%
1/25 • Number of events 1
Of the Serious Adverse Events, all were not related to the device. Of the other Adverse Events 3 were related to device and 2 were uncertain in relation.
|
|
Blood and lymphatic system disorders
Anemia
|
16.0%
4/25 • Number of events 4
Of the Serious Adverse Events, all were not related to the device. Of the other Adverse Events 3 were related to device and 2 were uncertain in relation.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.0%
1/25 • Number of events 1
Of the Serious Adverse Events, all were not related to the device. Of the other Adverse Events 3 were related to device and 2 were uncertain in relation.
|
|
Respiratory, thoracic and mediastinal disorders
Oxygen Desaturation
|
8.0%
2/25 • Number of events 2
Of the Serious Adverse Events, all were not related to the device. Of the other Adverse Events 3 were related to device and 2 were uncertain in relation.
|
|
General disorders
Electrolyte Imbalance
|
8.0%
2/25 • Number of events 2
Of the Serious Adverse Events, all were not related to the device. Of the other Adverse Events 3 were related to device and 2 were uncertain in relation.
|
|
General disorders
Alcohol Abuse/Withdrawal
|
4.0%
1/25 • Number of events 1
Of the Serious Adverse Events, all were not related to the device. Of the other Adverse Events 3 were related to device and 2 were uncertain in relation.
|
|
Injury, poisoning and procedural complications
Hematoma
|
4.0%
1/25 • Number of events 1
Of the Serious Adverse Events, all were not related to the device. Of the other Adverse Events 3 were related to device and 2 were uncertain in relation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place