Clinical trial NCT00958347: Omnifit Hydroxylapatite (HA) Hip Outcomes Study
Official title: Omnifit Hydroxylapatite (HA) Hip Outcomes Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2009-08-13
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Patients Will be Evaluated for Pain, Functional Level, and Clinical Complications Utilizing the Harris Hip Score.
timeFrame: 25 Years Post-Operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Medical Center
state: Indiana
city: New York
country: United States
facility: Hospital for Joint Disease/ Orthopaedic Institute
state: New York
city: Moon Township
country: United States
facility: Sewickley Valley Hospital
state: Pennsylvania
city: Maastricht
country: Netherlands
facility: Trialbureau Orthopedics
Study officials:
affiliation: Indiana University School of Medicine
name: William Capello, MD
role: STUDY_CHAIR
affiliation: Hospital for Joint Disease/ Orthopaedic Institute
name: William Jaffe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Trialbureau Orthopedics
name: Rudolph Geesink, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sewickley Valley Hospital
name: James D'Antonio, MD
role: STUDY_CHAIR
References: