A Two Centre Study to Assess the Stability and Long-term Performance of the C-Stem™ AMT in a Total Primary Hip Replacement

Study Overview
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Brief Summary
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The purpose of this study is to monitor the stability of the C-Stem™ AMT hip within the thigh bone when used in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical, standard x-ray assessments and special x-rays which allow the stability of the implant to be determined.

Official Title
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Prospective, Uncontrolled, Two-centre, RSA, Post-market Surveillance Study to Evaluate the Stability of the C-Stem™ AMT Femoral Component in Primary Total Hip Arthroplasty.

Conditions
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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
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* Device: C-Stem™ AMT Femoral Component (standard and high off-set variants)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: i) Male or female subjects, aged between 60 and 80 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 undergoing primary total hip replacement that are considered suitable for a cemented femoral stem and metal femoral head and an all polyethylene acetabular cup. 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) Subjects undergoing revision hip replacement iii) Subjects undergoing simultaneous bilateral hip replacements. iv) Subjects with a contralateral hip replacement, which was implanted less than six months previously or is not performing satisfactorily. v) Women who are pregnant. vi) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes. vii) Subjects who have participated in a clinical study with an investigational product in the last 12 months. viii) Subjects who are currently involved in any injury litigation claims.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: C-Stem™ AMT Femoral Component<br> | Device: C-Stem™ AMT Femoral Component (standard and high off-set variants)<br>* A polished triple tapered cemented femoral component for use in total hip replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distal migration of the femoral stem at the 5-year time point |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ML/AP translation and all rotations out to 5 years |  | pre-discharge, 3mths, 6mths, 1yr, 18mths, 2yrs, 3yrs and 5yrs post-surgery | 
| Harris Hip score |  | 3mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery | 
| Oxford Hip score |  | 3mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery | 
| Radiological analysis |  | 3mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip, Cemented