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

NHS Foundation Trust logo

NHS Foundation Trust

Status

Completed

Conditions

Osteoarthritis

Treatments

Procedure: Total Hip Replacement

Study type

Observational

Funder types

Other

Identifiers

NCT00293605
NS200361715

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

120 participants in 3 patient groups

1
Description:
C-stem implant
Treatment:
Procedure: Total Hip Replacement
2
Description:
Charnley Implant
Treatment:
Procedure: Total Hip Replacement
3
Description:
Exeter Implant
Treatment:
Procedure: Total Hip Replacement

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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