Omnifit Hydroxylapatite (HA) Hip Outcomes Study

July 30, 2014 updated by: Stryker Orthopaedics
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

226

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6202
        • Trialbureau Orthopedics
  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Medical Center
    • New York
      • New York, New York, United States, 10128
        • Hospital for Joint Disease/ Orthopaedic Institute
    • Pennsylvania
      • Moon Township, Pennsylvania, United States, 15108-4305
        • Sewickley Valley Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stryker Orthopaedics

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1987

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

August 11, 2009

First Submitted That Met QC Criteria

August 12, 2009

First Posted (Estimate)

August 13, 2009

Study Record Updates

Last Update Posted (Estimate)

August 19, 2014

Last Update Submitted That Met QC Criteria

July 30, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 01/04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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