Trilogy AB Acetabular Hip System Post Approval Study

Multicenter Post Approval Study of the Trilogy AB(R) Acetabular System

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.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis; Avascular Necrosis; Congenital Hip Dysplasia; Traumatic Arthritis
• Intervention / Treatment: Device: Trilogy AB Acetabular Hip Implant 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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Fort Lauderdale, Florida, United States, 33136
      • Shrock Orthopedic Research
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pre-op, 3 Month Post-Op and Annual Post-Op visits through 5 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At all follow-up visits through 5 Years and postcard follow-up 6 - 10 Years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: July 8, 2008
• First Submitted That Met QC Criteria: July 11, 2008
• First Posted (Estimate): July 15, 2008

Study Record Updates

• Last Update Posted (Estimate): November 26, 2014
• Last Update Submitted That Met QC Criteria: November 25, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Arthritis; Joint Disease; Hip Replacement; Ceramic; Total Hip; Total Hip Arthroplasty (THA)
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Hip Injuries; Musculoskeletal Abnormalities; Joint Dislocations; Arthritis; Necrosis; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital
• Other Study ID Numbers: 06-300; 06-300, Revised 3-1-2010 (Other Identifier: Zimmer - revision date)