Omnifit Hydroxylapatite (HA) Hip Outcomes Study

Not Applicable

Terminated

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Omnifit HA Hip Stem	Omnifit HA Hip Stem	Participants underwent total hip replacement surgery using the Omnifit HA Hip Stem.

Primary Outcome Measures

Name	Time	Method
Patients Will be Evaluated for Pain, Functional Level, and Clinical Complications Utilizing the Harris Hip Score.	25 Years Post-Operatively

Secondary Outcome Measures

Name	Time	Method

Locations (4): Hospital for Joint Disease/ Orthopaedic Institute
🇺🇸
New York, New York, United States
Indiana University Medical Center
🇺🇸
Indianapolis, Indiana, United States
Sewickley Valley Hospital
🇺🇸
Moon Township, Pennsylvania, United States
Trialbureau Orthopedics
🇳🇱
Maastricht, Netherlands