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

Study 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

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)

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

Intervention / Treatment
-----------------
* Device: SmartSet® HV bone cement
* Device: SmartSet® GHV bone cement


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kaplan-Meier survivorship |  | Annually | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score |  | Annually | 
| Oxford Hip Score |  | Annually | 
| Radiological Analysis |  | Annually | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hip, Bone Cement