Coxarthrosis
Conditions
Keywords
THA
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.
Interventions
The bone is pressed very hard together before implantation of femoral component.
PROCEDUREBone preparation technique: conventional technique
Bone is broached before implantation of femoral component.
Sponsors
Northern Orthopaedic Division, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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 |
|---|---|---|
| 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. |
Countries
Denmark
Outcome results
None listed