MINIMALLY INVASIVE SURGERY in Total Knee Arthroplasty

Phase 4

Terminated

• Conditions: Osteoarthritis of the Knee
• Interventions: Procedure: surgical technique

• Registration Number: NCT00853398
• Lead Sponsor: Smith & Nephew Orthopaedics AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Primary Completion: 2007-10
• Study Completion: 2007-12
• Study First Submitted: 2009-02-27
• Study First Submitted QC: 2009-02-27
• Study First Posted: 2009-03-02
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-22
• Last Update Posted: 2014-05-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Minimal Invasive Surgery,	surgical technique	-
Standard Surgical Technique	surgical technique	-

Primary Outcome Measures

Name	Time	Method
Pain and Range of Motion on the short term as efficacy measurements. Occurence of Adverse Events as safety measurements	1 year

Secondary Outcome Measures

Name	Time	Method
Occurence of Adverse Events and Radiolucent lines > 2mm Range of motion on the mid term	2 years

Trial Locations

Locations (1)

Orthopaedic Department, University Hospital; 🇩🇪 Tübingen, Germany