total knee replacement
Conditions
Interventions
Placement of total knee replacement in patients with severe knee deformity.
Operation with or without computer assited navigation.
3 months post-operatively a long leg CT scan is made.
Sponsors
Stryker Howmedica
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of this international multicentre clinical study is to compare the clinical, radiographic and CT scan results, obtained in patients undergoing a computer assisted TKR procedure with patients undergoing a TKR procedure using state of the art alignment technique but without a computer based system. 1. Clinical evaluations (no scores) will be performed pre-operatively, per-operatively and post-operatively prior to discharge. 2. Radiographic evaluations will be performed pre-operatively and post-operatively at 3 months. Each of the evaluations will require a long-length weight bearing antero-posterior, a standard antero-posterior and a lateral radiograph. 3. Computed tomography (CT) scans will be required post-operatively at 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Already mentioned above. | — |
Countries
Netherlands
Outcome results
None listed