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

This study has been completed.
Sponsor:
Information provided by:
Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00293605
First received: February 16, 2006
Last updated: May 6, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention
Osteoarthritis
 Procedure: Total Hip Replacement

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of Cemented Stem Design on Periprosthetic Bone Mass Following Primary Total Hip Arthroplasty

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Proximal femoral BMD change over 2 years measured by DXA [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Evaluation using patient centered questionnaire (Oxford Hip Score) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Surgeon centered clinical assessment (Harris Hip Score) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Plain radiographic assessment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Biochemical markers of bone formation and resorption measured from serum and urine samples using the Elecsys system. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Femoral prosthetic stem y-axis migration (subsidence), ans stem/shaft angulation change measured by EBRA. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood and Urine only


Enrollment: 120
Study Start Date: January 2004
Study Completion Date: April 2011
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
C-stem implant
 Procedure: Total Hip Replacement
Implantation of one of 3 stem designs
2
Charnley Implant
 Procedure: Total Hip Replacement
Implantation of one of 3 stem designs
3
Exeter Implant
 Procedure: Total Hip Replacement
Implantation of one of 3 stem designs

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pre-assessment clinics at Sheffield Hospitals, patients booked for hip replacements.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00293605

Locations
United Kingdom
Orthopaedic Department, Northern General Hospital
Sheffield, South Yorkshire, United Kingdom, S5 7AU
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Andrew J Hamer, FRCS STH NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Mr Andrew Hamer, Sheffield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00293605     History of Changes
Other Study ID Numbers: NS200361715
Study First Received: February 16, 2006
Last Updated: May 6, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
aseptic loosening
femoral stem design

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 19, 2013