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MINIMALLY INVASIVE SURGERY in Total Knee Arhtoplasty (MIS GEN II)

This study has been terminated.
(The results obtained 1 year after surgery were clearly indicative of the outcome and the investigators decided to terminate follow-up at that point.)
Sponsor:
Information provided by:
Smith & Nephew Orthopaedics AG
ClinicalTrials.gov Identifier:
NCT00853398
First received: February 27, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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:

  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 Radiogarphic 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.


Condition Intervention Phase
Osteoarthritis of the Knee
 Procedure: surgical technique
 Phase 4

Study Type: Interventional
Official Title: A Prospective (Non)-Randomized Controlled Multicenter Clinical Study Of the Genesis ii Total Knee System in Minimally Invasive Total Knee Arthroplasty

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Smith & Nephew Orthopaedics AG:

Primary Outcome Measures:
  • Pain and Range of Motion on the short term as efficacy measurements. Occurance of Adverse Events as safety measurements [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Occurance of Adverse Events and Radiolucnet 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
Estimated Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Minimal Invasive Surgery, Procedure: surgical technique
Active Comparator: Standard Surgical Technique Procedure: surgical technique

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • require primary uni- or bilateral total knee arthroplasty; available for 2 year follow up; provide informed consent; is in stable health for cardio-pulmonairy conditions.

Exclusion Criteria:

  • inefficient femoral or tibial bone stock; BMI >35; fixed felxion deformity >15 degrees; knee flexion of <90 degrees; varus/valgus deformity >20 degrees; active local infection; conditons that would compromise the 2 years follow up.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00853398

Locations
Germany
Orthopaedic Department, University Hospital
Tübingen, Germany, 72076
Sponsors and Collaborators
Smith & Nephew Orthopaedics AG
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00853398     History of Changes
Other Study ID Numbers: MIS_GEN_II_6112003
Study First Received: February 27, 2009
Last Updated: February 27, 2009
Health Authority: Belgium: Institutional Review Board
Spain: Ethics Committee
Italy: Ethics Committee

Keywords provided by Smith & Nephew Orthopaedics AG:
Primary Osteoarthritis of the knee.

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013