The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00853398
Recruitment Status : 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.)
First Posted : March 2, 2009
Last Update Posted : May 23, 2014
Information provided by:
Smith & Nephew, Inc.

Brief Summary:

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 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Procedure: surgical technique Phase 4

Study Type : Interventional  (Clinical Trial)
Official Title: A Prospective (Non)-Randomized Controlled Multicenter Clinical Study Of the Genesis ii Total Knee System in Minimally Invasive Total Knee Arthroplasty
Study Start Date : October 2004
Actual Primary Completion Date : October 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Minimal Invasive Surgery, Procedure: surgical technique
Active Comparator: Standard Surgical Technique Procedure: surgical technique

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

Secondary Outcome Measures :
  1. Occurence of Adverse Events and Radiolucent lines > 2mm Range of motion on the mid term [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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-pulmonary conditions.

Exclusion Criteria:

  • inefficient femoral or tibial bone stock; BMI >35; fixed flexion deformity >15 degrees; knee flexion of <90 degrees; varus/valgus deformity >20 degrees; active local infection; conditions that would compromise the 2 years follow up.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00853398

Orthopaedic Department, University Hospital
Tübingen, Germany, 72076
Sponsors and Collaborators
Smith & Nephew Orthopaedics AG Identifier: NCT00853398     History of Changes
Other Study ID Numbers: MIS_GEN_II_6112003
First Posted: March 2, 2009    Key Record Dates
Last Update Posted: May 23, 2014
Last Verified: May 2014

Keywords provided by Smith & Nephew, Inc.:
Primary Osteoarthritis of the knee.

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