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Trilogy AB Acetabular Hip System Post Approval Study

This study has been terminated.
(Sponsor business decision unrelated to clinical performance.)
Sponsor:
Information provided by (Responsible Party):
Zimmer, Inc.
ClinicalTrials.gov Identifier:
NCT00715026
First received: July 8, 2008
Last updated: November 25, 2014
Last verified: November 2014
  Purpose

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 Intervention Phase
Osteoarthritis
Avascular Necrosis
Congenital Hip Dysplasia
Traumatic Arthritis
Device: Trilogy AB Acetabular Hip Implant System
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Post Approval Study of the Trilogy AB(R) Acetabular System

Further study details as provided by Zimmer, Inc.:

Primary Outcome Measures:
  • Harris Hip Score [ Time Frame: Pre-op, 3 Month Post-Op and Annual Post-Op visits through 5 Years ] [ Designated as safety issue: No ]
    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. [ Time Frame: At all follow-up visits through 5 Years and postcard follow-up 6 - 10 Years ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 31
Study Start Date: April 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715026

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, Inc.
Investigators
Principal Investigator: Kevin Schrock, MD Schrock Orthopedic Research
Principal Investigator: Gwo-Chin Lee, MD University of Pennsylvania/Penn Presbyterian Hospital
  More Information

No publications provided

Responsible Party: Zimmer, Inc.
ClinicalTrials.gov Identifier: NCT00715026     History of Changes
Other Study ID Numbers: 06-300, 06-300, Revised 3-1-2010
Study First Received: July 8, 2008
Results First Received: November 13, 2013
Last Updated: November 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Zimmer, Inc.:
Arthritis
Total Hip
Ceramic
Hip Replacement
Total Hip Arthroplasty (THA)
Joint Disease

Additional relevant MeSH terms:
Arthritis
Hip Dislocation, Congenital
Osteoarthritis
Congenital Abnormalities
Joint Diseases
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 25, 2014