Omnifit Hydroxylapatite (HA) Hip Outcomes Study

Arthroplasty, Replacement, Hip Clinical Trial

Official title:

Omnifit Hydroxylapatite (HA) Hip Outcomes Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00958347
• Other study ID #: 01/04
• Status: Terminated
• Phase: N/A
• First received: August 11, 2009
• Last updated: July 30, 2014
• Start date: October 1987
• Est. completion date: May 2011

Study information

• Verified date: July 2014
• Source: Stryker Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 226
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip

Intervention

Device:
• Omnifit HA Hip Stem
Total Hip Replacement with Omnifit HA Hip Stem

Locations

Country	Name	City	State
Netherlands	Trialbureau Orthopedics	Maastricht
United States	Indiana University Medical Center	Indianapolis	Indiana
United States	Sewickley Valley Hospital	Moon Township	Pennsylvania
United States	Hospital for Joint Disease/ Orthopaedic Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Orthopaedics

Countries where clinical trial is conducted

United States,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients Will be Evaluated for Pain, Functional Level, and Clinical Complications Utilizing the Harris Hip Score.		25 Years Post-Operatively	No