Coxarthrosis
Conditions
Keywords
THA
Brief summary
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.
Interventions
PROCEDUREBone preparation technique: broaching
Sponsors
Northern Orthopaedic Division, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiostereometric analysis | 5 and 10 years follow-up | Stem subsidence (change) at 5 and 10 years measured with radiostereometric analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Periprosthetic bone mineral density | 5 years follow-up | Periprosthetic bone mineral density measured with Dual Energy X-ray Absorptiometry (DXA) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire | 5 years follow-up | Questionnaire of hip function |
Countries
Denmark
Outcome results
None listed