Avascular Necrosis, Congenital Hip Dysplasia, Osteoarthritis, Traumatic Arthritis
Conditions
Keywords
Arthritis, Total Hip, Ceramic, Hip Replacement, Total Hip Arthroplasty (THA), Joint Disease
Brief summary
This is a post-approval study with prospective enrollment in the United States and a retrospective enrollment outside the United States to obtain functional, quality of life and radiographic data, which will facilitate assessment of the clinical performance of the Zimmer Trilogy AB Acetabular Hip System.
Detailed description
To obtain functional, quality of life and radiographic data to evaluate the clinical performance of the Zimmer Trilogy AB Acetabular Hip System in primary total hip replacement surgery.
Interventions
DEVICETrilogy AB Acetabular Hip Implant System
Total hip replacement with ceramic on ceramic treatment surfaces.
Sponsors
Zimmer Biomet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Non-obese patients * The patient is a good candidate for a primary hip arthroplasty using the Zimmer Trilogy AB Acetabular Hip System. * Patient is willing and able to give informed consent to participate in the follow-up program. * Patient is suitable for surgery and able to participate in the follow-up program.
Exclusion criteria
* Skeletally immature * Rheumatoid arthritis * Osteoradionecrosis * Infection * Nerve or muscle disease that may have a negative affect on gait or weight bearing * Loss of abductor musculature in the affected limb * Poor bone stock * Poor skin coverage around the hip joint * Rapid disease progression as obvious by joint destruction or bone absorption seen on x-ray * Previous total or cemented hemi-arthroplasty of the affected hip * Previous pinning or plating of the affected hip * Patients with heavy labor jobs or extreme activity levels * Patients who participate in sports activities or require deep flexion * Patients who are obese * Patients who have other disabilities * Patients who are unwilling or unable to give consent, or to comply with the protocol and follow-up program.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score | Pre-op, 3 Month Post-Op and Annual Post-Op visits through 5 Years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Continued Assessment of Implant Survivorship and Incidences of Adverse Events. | At all follow-up visits through 5 Years and postcard follow-up 6 - 10 Years | A 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Surgery done on non-study consented hip | 1 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Trilogy AB Acetabular Hip Implant System |
|---|---|
| Age, Continuous | 58 Years STANDARD_DEVIATION 14 |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 25 |
| serious Total, serious adverse events | 6 / 25 |
Outcome results
Primary
Harris Hip Score
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.
Time frame: Pre-op, 3 Month Post-Op and Annual Post-Op visits through 5 Years
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trilogy AB Acetabular Hip Implant System | Harris Hip Score | Preop Harris Hip Scores | 52.7 units on a scale | Standard Deviation 11.6 |
| Trilogy AB Acetabular Hip Implant System | Harris Hip Score | 3 Months Harris Hip Score | 68.2 units on a scale | Standard Deviation 16.11 |
| Trilogy AB Acetabular Hip Implant System | Harris Hip Score | 1 Year Harris Hip Scores | 70 units on a scale | Standard Deviation 19.54 |
Secondary
Continued Assessment of Implant Survivorship and Incidences of Adverse Events.
A 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.
Time frame: At all follow-up visits through 5 Years and postcard follow-up 6 - 10 Years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trilogy AB Acetabular Hip Implant System | Continued Assessment of Implant Survivorship and Incidences of Adverse Events. | SAEs - Not device related | 11 adverse events |
| Trilogy AB Acetabular Hip Implant System | Continued Assessment of Implant Survivorship and Incidences of Adverse Events. | AEs - Not device related | 21 adverse events |
| Trilogy AB Acetabular Hip Implant System | Continued Assessment of Implant Survivorship and Incidences of Adverse Events. | AEs - Definitely device related | 3 adverse events |
| Trilogy AB Acetabular Hip Implant System | Continued Assessment of Implant Survivorship and Incidences of Adverse Events. | AEs - Uncertain relation to device | 2 adverse events |