Omnifit Hydroxylapatite (HA) Hip Outcomes Study

Stryker

Status: Terminated

Conditions: Arthroplasty, Replacement, Hip

Treatments: Device: Omnifit HA Hip Stem

Study type: Interventional

Funder types: Industry

Identifiers

NCT00958347

01/04

Details and patient eligibility

About

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.

Enrollment: 226 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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226 participants in 1 patient group

Omnifit HA Hip Stem

Other group

Description:

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

Treatment:

Device: Omnifit HA Hip Stem