Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
INTERVENTIONAL
2004-10-31
2007-12-31
Brief Summary
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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:
1. Assess whether the improvement in Pain and Range of motion per Knee Society scoring system and VAS score.
2. Assess whether there are any differences between the surgical techniques as regards complication rate.
3. Assess whether the hospital stay and the rehabilitation time (Straight leg raise, Active/passive ROM) of the patients differs between the two techniques.
4. 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:
1. Improvement in Pain and Function per Knee Society Scoring system
2. Number and Extent of Radiographic Lucencies \>2mm
3. Revision and knee-related adverse events
4. 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.
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Detailed Description
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Conditions
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Study Groups
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Minimal Invasive Surgery,
surgical technique
Standard Surgical Technique
surgical technique
Interventions
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surgical technique
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Smith & Nephew Orthopaedics AG
INDUSTRY
Locations
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Orthopaedic Department, University Hospital
Tübingen, , Germany
Countries
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Other Identifiers
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MIS_GEN_II_6112003
Identifier Type: -
Identifier Source: org_study_id
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