Prospective, Uncontrolled, Multi-Centre, Post-Marketing Surveillance Study to Evaluate the Long-Term Performance of Summit Tapered Hip in Cementless Total Hip Arthroplasty

DePuy International5 sites in 5 countries275 target enrollmentFebruary 2003

ConditionsRheumatoid Arthritis Osteoarthritis Post-traumatic Arthritis Collagen Disorders Avascular Necrosis Traumatic Femoral Fractures Nonunion of Femoral Fractures Congenital Hip Dysplasia Slipped Capital Femoral Epiphysis

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: DePuy International
Enrollment: 275
Locations: 5
Primary Endpoint: Kaplan-Meier survivorship calculated at the five-year time point
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to monitor the performance of the Summit™ hip in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.

Registry

clinicaltrials.gov

Start Date

February 2003

End Date

May 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

DePuy International

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•i) Male or female subjects, aged between 18 and 70 years (inclusive).
•ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
•iii) Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
•iv) Subjects who require primary total hip replacement and are considered suitable for a cementless femoral stem.

Exclusion Criteria

•i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
•ii) Subjects who have previously undergone a hemi-arthroplasty or total hip arthroplasty.
•iii) Women who are pregnant.
•iv) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
•v) Subjects who have participated in a clinical study with an investigational product in the last 12 months.
•vi) Subjects who are currently involved in any injury litigation claims.

Outcomes

Primary Outcomes

Kaplan-Meier survivorship calculated at the five-year time point

Time Frame: 5yrs post-surgery

Secondary Outcomes

Harris Hip score(6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery)
UCLA activity rating(6mths and Annually post-surgery)
Kaplan-Meier survivorship calculations(Annually)
Thigh pain analysis(6mths and Annually post-surgery)
Oxford score(6mths and Annually post-surgery)
Radiological analysis(pre-discharge, 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery)