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MINIMALLY INVASIVE SURGERY in Total Knee Arthroplasty

NCT00853398 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2014-05-23

No results posted yet for this study

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.

Conditions

  • Osteoarthritis of the Knee

Interventions

PROCEDURE

surgical technique

Sponsors & Collaborators

  • Smith & Nephew Orthopaedics AG

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2007-10-31
Completion
2007-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00853398 on ClinicalTrials.gov