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

Completed

• Conditions: Osteoarthritis
• Interventions: Procedure: Total Hip Replacement

• Registration Number: NCT00293605
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2006-02-16
• Study First Submitted QC: 2006-02-16
• Study First Posted: 2006-02-17
• Primary Completion: 2008-11
• Study Completion: 2011-04
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-06
• Last Update Posted: 2011-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Total Hip Replacement	C-stem implant
2	Total Hip Replacement	Charnley Implant
3	Total Hip Replacement	Exeter Implant

Primary Outcome Measures

Name	Time	Method
Proximal femoral BMD change over 2 years measured by DXA	2 years

Secondary Outcome Measures

Name	Time	Method
Biochemical markers of bone formation and resorption measured from serum and urine samples using the Elecsys system.	2 years
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
Femoral prosthetic stem y-axis migration (subsidence), ans stem/shaft angulation change measured by EBRA.	2 years

Trial Locations

Locations (1)

Orthopaedic Department, Northern General Hospital; 🇬🇧 Sheffield, South Yorkshire, United Kingdom