Compaction Total Hip Arthroplasty (THA) Bilateral
This trial is active, not recruiting.
|Treatments||bone preparation technique: compaction, bone preparation technique: broaching|
|Sponsor||Northern Orthopaedic Division, Denmark|
|Start date||May 2001|
|End date||September 2016|
|Trial size||20 participants|
|Trial identifier||NCT00317889, ON-04-002b-SKO|
This is a prospective, randomized study comparing two different bone preparation techniques for insertion of a porous coated titanium cementless femoral stem. Patients receiving a bilateral total hip replacement are randomized to conventional broaching on one side and compaction on the other side.
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
time frame: 10 years follow-up
Periprosthetic bone mineral density
time frame: 5 years follow-up
Male or female participants from 18 years up to 70 years old.
Inclusion Criteria: - 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 Exclusion Criteria: - 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.
|Official title||Compaction THA Bilateral|
|Principal investigator||Søren Kold, MD|
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