A multicentre prospective randomised intervention study to investigate computer assisted total knee arthroplasty (TKA) in severe knees.
Phase 3
- Conditions
- total knee replacement1002321310005944
- Registration Number
- NL-OMON31585
- Lead Sponsor
- Stryker Howmedica
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
male or female( non pregnant) over the age of 18 year at time of surgery
Medical diagnosis of: osteoarthritis, rheumatoid arthrosis, avascular necrosis or posttraumatic arthritis with criteria such as listed on page 6 of the study protocol
Exclusion Criteria
patients requiring a revision of a previous implanted total knee system
patients with active infection
patients with active malignancy
patients with an immobile hip
pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The aim of this international multicentre clinical study is to compare the<br /><br>clinical, radiographic and CT scan results, obtained in patients undergoing a<br /><br>computer assisted TKR procedure with patients undergoing a TKR procedure using<br /><br>state of the art alignment technique but without a computer based system.<br /><br><br /><br>1. Clinical evaluations (no scores) will be performed pre-operatively,<br /><br>per-operatively and post-operatively prior to discharge.<br /><br><br /><br>2. Radiographic evaluations will be performed pre-operatively and<br /><br>post-operatively at 3 months. Each of the evaluations will require a<br /><br>long-length weight bearing antero-posterior, a standard antero-posterior and a<br /><br>lateral radiograph.<br /><br><br /><br>3. Computed tomography (CT) scans will be required post-operatively at 3<br /><br>months.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Already mentioned above.</p><br>