A Study to Assess the Long-term Performance of SmartSet® HV and SmartSet® GHV Bone Cements in Primary Total Hip Replacement

Sponsor

DePuy International (Industry)

Overall Status

Completed

CT.gov ID

NCT00872066

Collaborator

(none)

243

Enrollment

Location

Arms

124

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis Osteoarthritis Post-traumatic Arthritis Collagen Disorders Avascular Necrosis Traumatic Femoral Fractures Nonunion of Femoral Fractures Congenital Hip Dysplasia Slipped Capital Femoral Epiphysis	Device: SmartSet® HV bone cement Device: SmartSet® GHV bone cement	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

243 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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)

Study Start Date :

Mar 1, 2006

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1) SmartSet® HV Bone Cement A high viscosity bone cement for use in total hip replacement (without gentamicin)	Device: SmartSet® HV bone cement A high viscosity bone cement for use in total hip replacement (without gentamicin)
Active Comparator: 2) SmartSet® GHV Bone Cement A high viscosity bone cement for use in total hip replacement (with gentamicin)	Device: SmartSet® GHV bone cement A high viscosity bone cement for use in total hip replacement (with gentamicin)

Arm

Intervention/Treatment

Active Comparator: 1) SmartSet® HV Bone Cement

A high viscosity bone cement for use in total hip replacement (without gentamicin)

Device: SmartSet® HV bone cement

A high viscosity bone cement for use in total hip replacement (without gentamicin)

Active Comparator: 2) SmartSet® GHV Bone Cement

A high viscosity bone cement for use in total hip replacement (with gentamicin)

Device: SmartSet® GHV bone cement

A high viscosity bone cement for use in total hip replacement (with gentamicin)

Outcome Measures

Primary Outcome Measures

Kaplan-Meier survivorship [Annually]

Secondary Outcome Measures

Harris Hip Score [Annually]
Oxford Hip Score [Annually]
Radiological Analysis [Annually]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female subjects, aged between 18 and 75 years (inclusive).
Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
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.
Subjects requiring primary total hip arthroplasty and are considered suitable for a cemented femoral component.

Exclusion Criteria:

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