Trilogy AB Acetabular Hip System Post Approval Study

• ClinicalTrials.gov Identifier: NCT00715026
• Recruitment Status: Terminated
• First Posted: July 15, 2008
• Results First Posted: November 26, 2014
• Last Update Posted: November 26, 2014
• Sponsor: Zimmer Biomet
• Information provided by (Responsible Party): Zimmer Biomet

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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis; Avascular Necrosis; Congenital Hip Dysplasia; Traumatic Arthritis	Device: Trilogy AB Acetabular Hip Implant System	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 31 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multicenter Post Approval Study of the Trilogy AB(R) Acetabular System
• Study Start Date: April 2009
• Actual Primary Completion Date: June 2012
• Actual Study Completion Date: June 2012

Arms and Interventions

Arm	Intervention/treatment
Trilogy AB Acetabular Hip Implant System; Post Approval Study of Device.	Device: Trilogy AB Acetabular Hip Implant System; Total hip replacement with ceramic on ceramic treatment surfaces.

Outcome Measures

Primary Outcome Measures :

1. Harris Hip Score [ Time Frame: 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 :

1. Continued Assessment of Implant Survivorship and Incidences of Adverse Events. [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Florida

Shrock Orthopedic Research

Fort Lauderdale, Florida, United States, 33136

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Zimmer Biomet

Investigators

• Principal Investigator: Kevin Schrock, MD; Schrock Orthopedic Research
• Principal Investigator: Gwo-Chin Lee, MD; University of Pennsylvania/Penn Presbyterian Hospital

More Information

• Responsible Party: Zimmer Biomet
• ClinicalTrials.gov Identifier: NCT00715026
• Other Study ID Numbers: 06-300; 06-300, Revised 3-1-2010 ( Other Identifier: Zimmer - revision date )
• First Posted: July 15, 2008
• Results First Posted: November 26, 2014
• Last Update Posted: November 26, 2014
• Last Verified: November 2014

Keywords provided by Zimmer Biomet:

Arthritis; Total Hip; Ceramic; Hip Replacement; Total Hip Arthroplasty (THA); Joint Disease

Additional relevant MeSH terms:

Arthritis; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Necrosis; Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Joint Dislocations; Wounds and Injuries; Hip Injuries; Musculoskeletal Abnormalities; Congenital Abnormalities