Computer-assisted Minimally Invasive total hip Surgery (MIS): a randomised controlled trial into the effectiveness compared to traditional total hip arthroplasty
Completed
- Conditions
- Hip diseasesMusculoskeletal Diseases
- Registration Number
- ISRCTN52538512
- Lead Sponsor
- niversity Medical Center Groningen (UMCG) (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 132
Inclusion Criteria
1. Minimum age of 18 years and maximum of 75 years of age
2. Admitted for primary cement-less unilateral Total Hip Arthroplasty (THA), due to primary or secondary osteoarthrosis
Prior to providing informed consent, patients will be made aware that they will be blinded to the size of the incision for the duration of the hospital stay.
Exclusion Criteria
1. Inflammatory polyarthritis
2. A history of previous surgery on the affected hip
3. Dementia
4. Not able to fill in questionnaires in the Dutch language
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Does computer-assisted MIS lead to a better recovery during the early postoperative period (three months), and at six months postoperatively to a recovery at least as good as THA with a traditional incision technique? <br><br>In this study, recovery is operationalised as the proportion of subjects with normal gait (no limping during walking) as objectified by gait analysis, and as the self-reported functional status and health-related quality of life.
- Secondary Outcome Measures
Name Time Method 1. Does computer-assisted MIS result in a decreased length of hospital stay compared to THA with a traditional incision technique?<br>2. Does computer-assisted MIS lead to the same or even better positioning of the prosthesis compared to THA with a traditional incision technique as measured by means of radiographic evaluation?<br>3. Does computer-assisted MIS lead to a decrease in perioperative complications compared to THA with a traditional incision technique?<br>4. Are there indications that computer-assisted MIS potentially saves costs compared to a traditional incision technique?