Omnifit Hydroxylapatite (HA) Hip Outcomes Study

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. Identifier: NCT00958347
Recruitment Status : Terminated (Terminated due to lagging follow-up)
First Posted : August 13, 2009
Results First Posted : August 19, 2014
Last Update Posted : August 19, 2014
Information provided by (Responsible Party):
Stryker Orthopaedics

Brief Summary:
The purpose of this study was 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 or disease Intervention/treatment
Arthroplasty, Replacement, Hip Device: Omnifit HA Hip Stem

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Omnifit Hydroxylapatite (HA) Hip Outcomes Study
Study Start Date : October 1987
Primary Completion Date : May 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement
U.S. FDA Resources

Arm Intervention/treatment
Omnifit HA Hip Stem
Participants underwent total hip replacement surgery using the Omnifit HA Hip Stem.
Device: Omnifit HA Hip Stem
Total Hip Replacement with Omnifit HA Hip Stem

Primary Outcome Measures :
  1. Patients Will be Evaluated for Pain, Functional Level, and Clinical Complications Utilizing the Harris Hip Score. [ Time Frame: 25 Years Post-Operatively ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

  • Severely 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.

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 identifier (NCT number): NCT00958347

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
Trialbureau Orthopedics
Maastricht, Netherlands, 6202
Sponsors and Collaborators
Stryker Orthopaedics
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

Responsible Party: Stryker Orthopaedics Identifier: NCT00958347     History of Changes
Other Study ID Numbers: 01/04
First Posted: August 13, 2009    Key Record Dates
Results First Posted: August 19, 2014
Last Update Posted: August 19, 2014
Last Verified: July 2014