Trilogy AB Acetabular Hip System Post Approval Study

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00715026
• Other study ID #: 06-300
• Secondary ID: 06-300, Revised
• Status: Terminated
• Phase: Phase 4
• First received: July 8, 2008
• Last updated: November 25, 2014
• Start date: April 2009
• Est. completion date: June 2012

Study information

• Verified date: November 2014
• Source: Zimmer, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Avascular Necrosis
• Congenital Hip Dysplasia
• Hip Dislocation, Congenital
• Osteoarthritis
• Traumatic Arthritis

Intervention

Device:
• Trilogy AB Acetabular Hip Implant System
Total hip replacement with ceramic on ceramic treatment surfaces.

Locations

Country	Name	City	State
United States	Shrock Orthopedic Research	Fort Lauderdale	Florida
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Pre-op, 3 Month Post-Op and Annual Post-Op visits through 5 Years	No
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.	At all follow-up visits through 5 Years and postcard follow-up 6 - 10 Years	Yes