Omnifit Hydroxylapatite (HA) Hip Outcomes Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

1987-10-31

Study Completion Date

2011-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Arthroplasty, Replacement, Hip

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Omnifit HA Hip Stem

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

Group Type OTHER

Omnifit HA Hip Stem

Intervention Type DEVICE

Total Hip Replacement with Omnifit HA Hip Stem

Interventions

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Omnifit HA Hip Stem

Total Hip Replacement with Omnifit HA Hip Stem

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No