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

Phase 4

Completed

• Conditions: Congenital Hip Dysplasia; Collagen Disorders; Rheumatoid Arthritis; Osteoarthritis; Avascular Necrosis; Slipped Capital Femoral Epiphysis; Post-traumatic Arthritis; Traumatic Femoral Fractures; Nonunion of Femoral Fractures
• Interventions: Device: SmartSet® HV bone cement; Device: SmartSet® GHV bone cement

• Registration Number: NCT00872066
• Lead Sponsor: DePuy International

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2009-03-19
• Study First Submitted QC: 2009-03-30
• Study First Posted: 2009-03-31
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-02
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 243

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1) SmartSet® HV Bone Cement	SmartSet® HV bone cement	A high viscosity bone cement for use in total hip replacement (without gentamicin)
2) SmartSet® GHV Bone Cement	SmartSet® GHV bone cement	A high viscosity bone cement for use in total hip replacement (with gentamicin)

Primary Outcome Measures

Name	Time	Method
Kaplan-Meier survivorship	Annually

Secondary Outcome Measures

Name	Time	Method
Oxford Hip Score	Annually
Radiological Analysis	Annually
Harris Hip Score	Annually

Trial Locations

Locations (1)

Orthopaedic-traumatology Clinic University Hospital Martin; 🇸🇰 Martin, Slovakia