Overview

This trial is active, not recruiting.

Conditions rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic femoral fractures, nonunion of femoral fractures, congenital hip dysplasia, slipped capital femoral epiphysis
Treatments smartset® hv bone cement, smartset® ghv bone cement
Phase phase 4
Sponsor DePuy International
Start date March 2006
End date December 2016
Trial size 243 participants
Trial identifier NCT00872066, CT02/11

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
A high viscosity bone cement for use in total hip replacement (without gentamicin)
smartset® hv bone cement
A high viscosity bone cement for use in total hip replacement (without gentamicin)
(Active Comparator)
A high viscosity bone cement for use in total hip replacement (with gentamicin)
smartset® ghv bone cement
A high viscosity bone cement for use in total hip replacement (with gentamicin)

Primary Outcomes

Measure
Kaplan-Meier survivorship
time frame: Annually

Secondary Outcomes

Measure
Harris Hip Score
time frame: Annually
Oxford Hip Score
time frame: Annually
Radiological Analysis
time frame: Annually

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

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)
Principal investigator Libor Nečas, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by DePuy International.