Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components
Phase 4
Completed
- Conditions
- Osteoarthritis of Hip
- Interventions
- Device: Stemless femoral componentDevice: IPS, Depuy cementless femoral stem
- Registration Number
- NCT00957970
- Lead Sponsor
- Ewha Womans University
- Brief Summary
The purpose of this study is to determine if there is a difference in stress shielding and bone resorption of the proximal femur in two anatomical stem total hip designs.
- Detailed Description
Stress shielding related bone resorption in the proximal femur after total hip arthroplasty continues to be a problem. The purpose of this prospective, randomized study was to evaluate which of the two anatomical stem designs achieved a more physiological load transfer by assessing bone mineral changes in the proximal femur after stem implantation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- Osteoarthritis of hip joint requiring total hip arthroplasty
Exclusion Criteria
- Neurologic disorders affecting motor function of lower extremity
- foot and ankle disorders limiting ambulation of the patient
- Patients with bone metabolic disorders other than osteoporosis which prevents normal bone metabolism
- Multi-systemic inflammatory arthritis which debilitates patients other than hip joint.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stemless femoral component Stemless femoral component Stemless PROXIMA femoral component Stemmed femoral component IPS, Depuy cementless femoral stem IPS, proximal anatomical fit stemmed femoral component
- Primary Outcome Measures
Name Time Method Bone mineral density of surrounding proximal femur according to Gruen zones At least 2years after surgery
- Secondary Outcome Measures
Name Time Method Harris hip score 2 years
Trial Locations
- Locations (1)
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of