Omnifit Hydroxylapatite (HA) Hip Outcomes Study

This study has been terminated.
(Terminated due to lagging follow-up)
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT00958347
First received: August 11, 2009
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Arthroplasty, Replacement, Hip
Device: Omnifit HA Hip Stem

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Omnifit Hydroxylapatite (HA) Hip Outcomes Study

Resource links provided by NLM:


Further study details as provided by Stryker Orthopaedics:

Primary Outcome Measures:
  • Patients Will be Evaluated for Pain, Functional Level, and Clinical Complications Utilizing the Harris Hip Score. [ Time Frame: 25 Years Post-Operatively ] [ Designated as safety issue: No ]

Enrollment: 226
Study Start Date: October 1987
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00958347

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

No publications provided

Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT00958347     History of Changes
Other Study ID Numbers: 01/04
Study First Received: August 11, 2009
Results First Received: July 30, 2014
Last Updated: July 30, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 14, 2014