NCT00958347

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 1987

Longer than P75 for not_applicable

Geographic Reach
2 countries

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1987

Completed
21.9 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

August 19, 2014

Completed
Last Updated

August 19, 2014

Status Verified

July 1, 2014

Enrollment Period

23.6 years

First QC Date

August 11, 2009

Results QC Date

July 30, 2014

Last Update Submit

July 30, 2014

Conditions

Arthroplasty, Replacement, Hip

Outcome Measures

Primary Outcomes (1)

  • Patients Will be Evaluated for Pain, Functional Level, and Clinical Complications Utilizing the Harris Hip Score.

    25 Years Post-Operatively

Study Arms (1)

Omnifit HA Hip Stem

OTHER

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

Device: Omnifit HA Hip Stem

Interventions

Omnifit HA Hip StemDEVICE

Total Hip Replacement with Omnifit HA Hip Stem

Omnifit HA Hip Stem

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

Location

Hospital for Joint Disease/ Orthopaedic Institute

New York, New York, 10128, United States

Location

Sewickley Valley Hospital

Moon Township, Pennsylvania, 15108-4305, United States

Location

Trialbureau Orthopedics

Maastricht, 6202, Netherlands

Location

Results Point of Contact

Title
Director of Clinical Research
Organization
Stryker Orthopaedics
ellen.axelson@stryker.com
201-831-5401

Study Officials

  • William Capello, MD

    Indiana University School of Medicine

    STUDY CHAIR

  • William Jaffe, MD

    Hospital for Joint Disease/ Orthopaedic Institute

    PRINCIPAL INVESTIGATOR

  • Rudolph Geesink, MD

    Trialbureau Orthopedics

    PRINCIPAL INVESTIGATOR

  • James D'Antonio, MD

    Sewickley Valley Hospital

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2009

First Posted

August 13, 2009

Study Start

October 1, 1987

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

August 19, 2014

Results First Posted

August 19, 2014

Record last verified: 2014-07

Locations

NL(1)US(3)