Effect of Cemented Stem Design on Periprosthetic Bone Mass Following Primary Total Hip Arthroplasty

Study Overview
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Brief Summary
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Total hip replacement is a common procedure for the treatment of osteoarthrosis of the hips, the aims of this study are to determine the effect of implant stem design on bone quality surrounding the implant using three stem designs that are routinely implanted at this hospital.

Detailed Description
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120 patients will undergo routine hip replacements using either the C-Stem, Exeter Stem or Charnley stem implants. Patients will be clinically evaluated pre-operatively and randomised to one of the three implants. Post-operatively, patients will be clinically reviewed for 2 years using bone mineral density scans, radiological review, blood and urine analysis for bone markers and validated questionnaires to assess clinical data (Oxford Hip and Harries Hip). Patients will be assessed for prothesis migration using the EBRA methods.

Official Title
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Effect of Cemented Stem Design on Periprosthetic Bone Mass Following Primary Total Hip Arthroplasty

Conditions
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Osteoarthritis

Intervention / Treatment
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* Procedure: Total Hip Replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients must be aged 60 yrs or more uncomplicated primary or secondary osteoarthritis of the hip undergoing unilateral cemented total hip arthroplasty using a metal on polyethylene bearing couple. Exclusion Criteria: metabolic bone disorders, systemic disorders such as rheumatoid arthritis and patients who have taken pharmacological doses of oral steroids, hormone replacement therapy, tamoxifen, calcium or vitamin D supplements within the last year. Patients with a prior history of bisphosphonates and women of child bearing age.

Ages Eligible for Study
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Minimum Age: 60 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>C-stem implant | Procedure: Total Hip Replacement<br>* Implantation of one of 3 stem designs<br>|
| 2<br>Charnley Implant | Procedure: Total Hip Replacement<br>* Implantation of one of 3 stem designs<br>|
| 3<br>Exeter Implant | Procedure: Total Hip Replacement<br>* Implantation of one of 3 stem designs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proximal femoral BMD change over 2 years measured by DXA |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Evaluation using patient centered questionnaire (Oxford Hip Score) |  | 2 years | 
| Surgeon centered clinical assessment (Harris Hip Score) |  | 2 years | 
| Plain radiographic assessment |  | 2 years | 
| Biochemical markers of bone formation and resorption measured from serum and urine samples using the Elecsys system. |  | 2 years | 
| Femoral prosthetic stem y-axis migration (subsidence), ans stem/shaft angulation change measured by EBRA. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aseptic loosening, femoral stem design