ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00293605
Recruitment Status : Completed
First Posted : February 17, 2006
Last Update Posted : May 9, 2011
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment
Osteoarthritis Procedure: Total Hip Replacement

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 Type : Observational
Actual Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of Cemented Stem Design on Periprosthetic Bone Mass Following Primary Total Hip Arthroplasty
Study Start Date : January 2004
Actual Primary Completion Date : November 2008
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Proximal femoral BMD change over 2 years measured by DXA [ Time Frame: 2 years ]

Secondary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples Without DNA
Blood and Urine only


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Mr Andrew Hamer, Sheffield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00293605     History of Changes
Other Study ID Numbers: NS200361715
First Posted: February 17, 2006    Key Record Dates
Last Update Posted: May 9, 2011
Last Verified: May 2011

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