Compaction Femur Preparation for Cementless Total Hip Arthroplasty (THA) Unilateral
- Conditions
- Coxarthrosis
- Registration Number
- NCT00318396
- Lead Sponsor
- Northern Orthopaedic Division, Denmark
- Brief Summary
This is a prospective, randomized study comparing two different bone preparation techniques for insertion of a hydroxylapatite (HA) coated titanium cementless femoral stem. Patients who receive a unilateral total hip replacement are randomized to either conventional broaching or compaction.
Hypothesis: Compaction results in significantly less stem migration \[evaluated by radiostereometric analysis (RSA)\], less peri-prosthetic bone mineral density (BMD) loss \[evaluated by dual energy x-ray absorptiometry (DEXA)\], and a higher Harris hip score after two years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 26
- Patients with primary arthritis in the hip
- Patients with sufficient bone density to allow uncemented implantation of a femoral component
- Informed patient consent in writing
- Patients with neuromuscular or vascular disease in the affected leg
- Patients found upon operation to be unsuited for uncemented acetabulum component
- Patients who regularly take non-steroidal anti-inflammatory drugs (NSAIDs) and cannot interrupt intake for the postoperative phase of the study
- Patients with fracture sequelae
- Female patients of childbearing capacity
- Hip joint dysplasia
- Sequelae to previous hip joint disorder in childhood
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To examine a possible difference in density of bones around implantation of femoral component. 5 years A check-up by means of DEXA scanning after 1 week, 1 year, 2 years and 5 years.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Northern Orthopaedic Division, Clinic Farsoe, Aalborg University Hospital
🇩🇰Farsoe, Northern Jutland, Denmark