Compaction Femur Preparation for Cementless Total Hip Arthroplasty (THA) Unilateral
This trial is active, not recruiting.
|Treatments||bone preparation technique: compaction, bone preparation technique: conventional technique|
|Sponsor||Northern Orthopaedic Division, Denmark|
|Start date||June 2004|
|End date||December 2015|
|Trial size||26 participants|
|Trial identifier||NCT00318396, ON-04-002a-SKO|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
To examine a possible difference in density of bones around implantation of femoral component.
time frame: 5 years
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 Femur Total Hip Arthroplasty (THA) Uni-lateral|
|Principal investigator||Soeren Kold, MD|
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