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Trial Comparing Navigated and Conventional Implantation Techniques in Knee Replacement Surgery

NCT00431509 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 477

Last updated 2007-04-24

No results posted yet for this study

Summary

This study is undertaken to investigate the effect of navigated knee implantation surgery on physical function, joint stiffness, pain, quality of life and coordinative abilities.

One group of patients will receive navigated knee implantation surgery, the other traditional knee implantation surgery, without use of the navigation system.

The study is designed as a randomized trial. That means that all patients who have given their consent to participate in this study will be allocated to either navigated or conventional surgery by chance.

A total of 477 patients will be included in this study and will be followed up for 12 month.

In this period all patients will be asked to fill in functional and quality of life questionnaires at baseline, 6 weeks and 3, 6 and 12 month follow-up. Coordinative abilities will be evaluated once in the time-frame 3 to 6 months postoperatively.

Conditions

Interventions

PROCEDURE

conventional vs. navigated total knee arthroplasty

Sponsors & Collaborators

  • DePuy International

    collaborator INDUSTRY

  • University Hospital Schleswig-Holstein

    lead OTHER

Principal Investigators

  • Joachim Hassenpflug, Prof. Dr. · University of Schleswig-Holstein, Kiel Medical Center

  • Thoralf R Liebs, Dr. · University of Schleswig-Holstein, Kiel Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Completion
2009-06-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT00431509 on ClinicalTrials.gov