A Prospective, Randomised, Uncontrolled, Single-Centre, Post-Market Surveillance Study To Evaluate The Performance Of SmartSet® HV and SmartSet® GHV Bone Cements In Primary Cemented Total Hip Arthroplasty(THA)

DePuy International1 site in 1 country243 target enrollmentMarch 2006

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: 243
Locations: 1
Primary Endpoint: Kaplan-Meier survivorship
Status: Completed
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 artificial hip joints implanted with two different bone cements, SmartSet® HV and SmartSet® GHV, in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to SmartSet® HV or SmartSet® GHV and will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments

Registry

clinicaltrials.gov

Start Date

March 2006

End Date

July 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

DePuy International

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•i) Male or female subjects, aged between 18 and 75 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 requiring primary total hip arthroplasty and are considered suitable for a cemented femoral component.

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) Women who are pregnant.
•iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
•iv) Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).
•v) Subjects who are currently involved in any injury litigation claims.
•vi) Subjects with contraindications normally applicable to the use of conventional bone cement, in accordance with the manufacturer's Instructions For Use.