Omnifit Hydroxylapatite (HA) Hip Outcomes Study

Stopped early · Not applicable

Conditions studied: Arthroplasty, Replacement, Hip

In brief

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.

Key facts

Study ID

NCT00958347

Run by

Stryker Orthopaedics

People needed

226

Starts

1987-10-01

Expected to finish

2011-05-01

Last updated by the study team

2014-08-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Indiana University Medical Center — Indianapolis, Indiana, United States
• Hospital for Joint Disease/ Orthopaedic Institute — New York, New York, United States
• Sewickley Valley Hospital — Moon Township, Pennsylvania, United States
• Trialbureau Orthopedics — Maastricht, Netherlands

Full record on ClinicalTrials.gov

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