Omnifit HA Hip Outcomes Study Omnifit Hydroxylapatite (HA) Hip Outcomes Study

This study has been terminated.
(Terminated due to lagging follow-up)
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT00958347
First received: August 11, 2009
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to obtain up to 25 year post-operative data on the Omnifit Hydroxylapatite (HA) Hip System in support of the hypothesis that it is a satisfactory system for reducing implant loosening, permitting tissue bonding onto the hydroxylapatite surfaces of the implant and providing a safe, efficient, and well-functioning hip in a wide spectrum of clinical circumstances.


Condition Intervention
Arthropathy of Hip
Device: Omnifit HA Hip Stem

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Omnifit Hydroxylapatite (HA) Hip Outcomes Study

Resource links provided by NLM:


Further study details as provided by Stryker Orthopaedics:

Primary Outcome Measures:
  • Patients will be evaluated for pain, functional level, and clinical complications utilizing the Harris Hip Score. [ Time Frame: 25 Years Post-Operatively ] [ Designated as safety issue: No ]

Enrollment: 262
Study Start Date: October 1987
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omnifit HA Hip Stem Device: Omnifit HA Hip Stem
Total Hip Replacement with Omnifit HA Hip Stem

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For use as a universal hip replacement:

  • Acute femoral neck fracture.
  • Non-union of femoral head and neck fractures.
  • Aseptic necrosis of the femoral head.
  • Osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
  • Salvage of failed total hip arthroplasty.

For use as a total hip replacement:

  • Severly disabled joints resulting from painful osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis.
  • Revision of previous unsuccessful femoral head replacement, cup arthroplasty, or other procedure.

Exclusion Criteria:

  • Active infection in or near the hip joint.
  • Pathological bone conditions which would significantly compromise the ability to carry physiologic stress levels and for which bone grafting would be inappropriate (i.e. severe osteoporosis, Paget's Disease, renal osteodystrophy, etc.).
  • Neuro-muscular disorders in which the potentially adverse effects on prosthesis function are not outweighed by the benefits to be gained by the patient from usage of the implant.
  • Mental disorders which would compromise essential patient post-operative care.
  • Skeletal immaturity.
  • Extreme obesity.
  • Significant probability that patient could not return for required follow-up evaluations.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00958347

Locations
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
United States, New York
Hospital for Joint Disease/ Orthopaedic Institute
New York, New York, United States, 10128
United States, Pennsylvania
Sewickley Valley Hospital
Moon Township, Pennsylvania, United States, 15108-4305
Netherlands
Trialbureau Orthopedics
Maastricht, Netherlands, 6202
Sponsors and Collaborators
Stryker Orthopaedics
Investigators
Study Chair: William Capello, MD Indiana University School of Medicine
Principal Investigator: William Jaffe, MD Hospital for Joint Disease/ Orthopaedic Institute
Principal Investigator: Rudolph Geesink, MD Trialbureau Orthopedics
Study Chair: James D'Antonio, MD Sewickley Valley Hospital
  More Information

No publications provided

Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT00958347     History of Changes
Other Study ID Numbers: 01/04
Study First Received: August 11, 2009
Last Updated: May 28, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 14, 2014