Trilogy AB Acetabular Hip System Post Approval Study
Primary Purpose
Osteoarthritis, Avascular Necrosis, Congenital Hip Dysplasia
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Trilogy AB Acetabular Hip Implant System
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Arthritis, Total Hip, Ceramic, Hip Replacement, Total Hip Arthroplasty (THA), Joint Disease
Eligibility Criteria
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.
Sites / Locations
- Shrock Orthopedic Research
- University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Trilogy AB Acetabular Hip Implant System
Arm Description
Post Approval Study of Device.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00715026
Brief Title
Trilogy AB Acetabular Hip System Post Approval Study
Official Title
Multicenter Post Approval Study of the Trilogy AB(R) Acetabular System
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
Sponsor business decision unrelated to clinical performance.
Study Start Date
April 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Avascular Necrosis, Congenital Hip Dysplasia, Traumatic Arthritis
Keywords
Arthritis, Total Hip, Ceramic, Hip Replacement, Total Hip Arthroplasty (THA), Joint Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trilogy AB Acetabular Hip Implant System
Arm Type
Other
Arm Description
Post Approval Study of Device.
Intervention Type
Device
Intervention Name(s)
Trilogy AB Acetabular Hip Implant System
Intervention Description
Total hip replacement with ceramic on ceramic treatment surfaces.
Primary Outcome Measure Information:
Title
Harris Hip Score
Description
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
Secondary Outcome Measure Information:
Title
Continued Assessment of Implant Survivorship and Incidences of Adverse Events.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Schrock, MD
Organizational Affiliation
Schrock Orthopedic Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gwo-Chin Lee, MD
Organizational Affiliation
University of Pennsylvania/Penn Presbyterian Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shrock Orthopedic Research
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
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