MINIMALLY INVASIVE SURGERY in Total Knee Arthroplasty (MIS GEN II)
Overall study design:
A prospective, randomized, multi-center clinical studies comparing the minimal invasive and the standard surgical total knee replacement technique (control) using the Genesis II total knee system. The study will collect efficacy, safety and socio-economical data over 2 years. An additional 5 years follow-up interval is optional. The objectives (short-term follow-up) of the study are to:
- Assess whether the improvement in Pain and Range of motion per Knee Society scoring system and VAS score.
- Assess whether there are any differences between the surgical techniques as regards complication rate.
- Assess whether the hospital stay and the rehabilitation time (Straight leg raise, Active/passive ROM) of the patients differs between the two techniques.
- Assess the x-ray mechanical alignment between the two techniques.
Attempts will be made to assess whether the collected peri-operative data (including incision length, blood loss, wound appearance, hospital readmissions and operative time) differs between the two surgical techniques.
The primary objectives (mid-term follow-up) of the study are to:
- Improvement in Pain and Function per Knee Society Scoring system
- Number and Extent of Radiographic Lucencies >2mm
- Revision and knee-related adverse events
- Improvement in Quality-of-life via the VAS score
5 investigational sites will participate and enroll a total of approximately 250 patients over a 12 months period. Thus, each site will enroll 50 patients.
|Official Title:||A Prospective (Non)-Randomized Controlled Multicenter Clinical Study Of the Genesis ii Total Knee System in Minimally Invasive Total Knee Arthroplasty|
- Pain and Range of Motion on the short term as efficacy measurements. Occurence of Adverse Events as safety measurements [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Occurence of Adverse Events and Radiolucent lines > 2mm Range of motion on the mid term [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2004|
|Study Completion Date:||December 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
|Experimental: Minimal Invasive Surgery,||Procedure: surgical technique|
|Active Comparator: Standard Surgical Technique||Procedure: surgical technique|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00853398
|Orthopaedic Department, University Hospital|
|Tübingen, Germany, 72076|