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

Sheffield Teaching Hospitals NHS Foundation Trust120 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

120

Conditions

Osteoarthritis

Interventions

Total Hip ReplacementPROCEDURE

Implantation of one of 3 stem designs

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Orthopaedic Department, Northern General Hospital

Sheffield, South Yorkshire, United Kingdom

Outcomes

Primary Outcomes

Proximal femoral BMD change over 2 years measured by DXA

Time frame: 2 years

Secondary Outcomes

Clinical Evaluation using patient centered questionnaire (Oxford Hip Score)

Time frame: 2 years

Surgeon centered clinical assessment (Harris Hip Score)

Time frame: 2 years

Plain radiographic assessment

Time frame: 2 years

Biochemical markers of bone formation and resorption measured from serum and urine samples using the Elecsys system.

Time frame: 2 years

Femoral prosthetic stem y-axis migration (subsidence), ans stem/shaft angulation change measured by EBRA.

Time frame: 2 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.