Total hip arthroplasty by direct anterior approach versus posterolateral approach. A randomized clinical trial.
Completed
- Conditions
- degenerative hip diseaseOsteoarthritis of the hip10023213
- Registration Number
- NL-OMON35973
- Lead Sponsor
- Isala Klinieken
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
- Mentally competent men and women with debilitating osteoarthritis of the hip indicated for a total hip arthroplasty
- Signed informed consent
- Age older than 18 years
Exclusion Criteria
- BMI > 35
- Contralateral hipprosthesis
- Contralateral , debilitating osteoarthritis of the hip
- Standard contraindications, as prevailing for elective total hip arthroplasty (pregnancy, infection and severe comorbidity of pulmonary, cardiac or metabolic nature)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Patient satisfactory with HOOS-functioning in daily life subscale 6 weeks<br /><br>postoperative as primary outcome. The definition of success (superiority) for<br /><br>the individual patient is: a clinical relevant difference is defined as 10<br /><br>points or more at the HOOS-functioning in daily life subscale.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Besides the other 4 HOOS-subscales and HOOS total score, the following<br /><br>secundary outcomes will be used to evaluate effectivity of both approaches:<br /><br>- VAS pain en VAS satisfaction<br /><br>- SF-36<br /><br>- Clinical data: blood loss, surgery time, incision length, length of hospital<br /><br>stay<br /><br>- Radiological: version and inclination cup, version and varus/valgus stem<br /><br>- Complications: bleeding, infection, dislocation, meralgia paraesthetica,<br /><br>venous thromboembolism and loosening<br /><br>Simultaneously course in time of HOOS, VAS en SF36 will be analysed.</p><br>