Effect of Cemented Stem Design on Periprosthetic Bone Mass Following Primary Total Hip Arthroplasty
1 other identifier
observational
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2004
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 16, 2006
CompletedFirst Posted
Study publicly available on registry
February 17, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedMay 9, 2011
May 1, 2011
4.8 years
February 16, 2006
May 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proximal femoral BMD change over 2 years measured by DXA
2 years
Secondary Outcomes (5)
Clinical Evaluation using patient centered questionnaire (Oxford Hip Score)
2 years
Surgeon centered clinical assessment (Harris Hip Score)
2 years
Plain radiographic assessment
2 years
Biochemical markers of bone formation and resorption measured from serum and urine samples using the Elecsys system.
2 years
Femoral prosthetic stem y-axis migration (subsidence), ans stem/shaft angulation change measured by EBRA.
2 years
Study Arms (3)
1
C-stem implant
2
Charnley Implant
3
Exeter Implant
Interventions
Eligibility Criteria
Pre-assessment clinics at Sheffield Hospitals, patients booked for hip replacements.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Orthopaedic Department, Northern General Hospital
Sheffield, South Yorkshire, S5 7AU, United Kingdom
Biospecimen
Blood and Urine only
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew J Hamer, FRCS
STH NHS Foundation Trust
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 16, 2006
First Posted
February 17, 2006
Study Start
January 1, 2004
Primary Completion
November 1, 2008
Study Completion
April 1, 2011
Last Updated
May 9, 2011
Record last verified: 2011-05