Trilogy AB Acetabular Hip System Post Approval Study

Phase 4

Terminated

• Conditions: Avascular Necrosis; Traumatic Arthritis; Osteoarthritis; Congenital Hip Dysplasia
• Interventions: Device: Trilogy AB Acetabular Hip Implant System

• Registration Number: NCT00715026
• Lead Sponsor: Zimmer Biomet

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.

Study Timeline

• Study First Submitted: 2008-07-08
• Study First Submitted QC: 2008-07-11
• Study First Posted: 2008-07-15
• Study Start: 2009-04
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2013-11-13
• Status Verified: 2014-11
• Results First Submitted QC: 2014-11-25
• Last Update Submitted: 2014-11-25
• Results First Posted: 2014-11-26
• Last Update Posted: 2014-11-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trilogy AB Acetabular Hip Implant System	Trilogy AB Acetabular Hip Implant System	Post Approval Study of Device.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Shrock Orthopedic Research; 🇺🇸 Fort Lauderdale, Florida, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States