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Completed

NCT Number: NCT00293605

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Orthopaedic Department, Northern General Hospital

Sheffield, South Yorkshire, S5 7AU, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Total hip replacement

Procedure

Implantation of one of 3 stem designs

Primary outcomes

  1. Proximal femoral BMD change over 2 years measured by DXA

    Time frame: 2 years

Secondary outcomes

  1. Clinical Evaluation using patient centered questionnaire (Oxford Hip Score)

    Time frame: 2 years

  2. Surgeon centered clinical assessment (Harris Hip Score)

    Time frame: 2 years

  3. Plain radiographic assessment

    Time frame: 2 years

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

    Time frame: 2 years

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

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Registry information

Important dates

Study start
2004
Primary completion
2008
Study completion
2011
First posted
Feb 17, 2006
Registry last updated
May 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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