MINIMALLY INVASIVE SURGERY in Total Knee Arthroplasty

Osteoarthritis of the Knee Clinical Trial

— MIS GEN II  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00853398
• Other study ID #: MIS_GEN_II_6112003
• Status: Terminated
• Phase: Phase 4
• First received: February 27, 2009
• Last updated: May 22, 2014
• Start date: October 2004
• Est. completion date: December 2007

Study information

• Verified date: May 2014
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review BoardSpain: Ethics CommitteeItaly: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: December 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Procedure:
• surgical technique

Locations

Country	Name	City	State
Germany	Orthopaedic Department, University Hospital	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew Orthopaedics AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain and Range of Motion on the short term as efficacy measurements. Occurence of Adverse Events as safety measurements		1 year	Yes
Secondary	Occurence of Adverse Events and Radiolucent lines > 2mm Range of motion on the mid term		2 years	Yes