NCT00872066

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

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 243 (actual)
• Sponsor: DePuy International · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
DEVICE	SmartSet® HV bone cement	A high viscosity bone cement for use in total hip replacement (without gentamicin)
DEVICE	SmartSet® GHV bone cement	A high viscosity bone cement for use in total hip replacement (with gentamicin)

Timeline

• Start date: 2006-03-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2009-03-31
• Last updated: 2017-03-03

Locations

1 site across 1 country: Slovakia