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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:
ClinicalTrials.gov Identifier:
NCT00715026
First Posted: July 15, 2008
Last Update Posted: November 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zimmer Biomet
  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: 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

Resource links provided by NLM:


Further study details as provided by Zimmer Biomet:

Primary Outcome Measures:
  • 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:
  • 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.


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 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     History of Changes
Other Study ID Numbers: 06-300
06-300, Revised 3-1-2010 ( Other Identifier: Zimmer - revision date )
First Submitted: July 8, 2008
First Posted: July 15, 2008
Results First Submitted: November 13, 2013
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
Osteoarthritis
Necrosis
Hip Dislocation
Hip Dislocation, Congenital
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes
Joint Dislocations
Bone Diseases
Wounds and Injuries
Hip Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities