Trial Comparing Navigated and Conventional Implantation Techniques in Knee Replacement Surgery

April 23, 2007 updated by: University Hospital Schleswig-Holstein

A Randomized Trial Comparing Navigated and Conventional Implantation Techniques in Knee Replacement Surgery. Influence on Operative Result, Health-Related Quality of Life, and Coordinative Abilities.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Various risk factors influencing the success of Total Knee Arthroplasty (TKA) have been studied.

Today age, gender, primary or revision surgery, comorbidities and baseline characteristics are known to influence the health-related quality of life after TKA.

It is thought, that accurate mechanical alignment and ligament balance ensure optimal kinematic performance and wear, which in turn improves long-term outcome.

During preparation of the bone for the implantation of the knee prosthesis, numerous cuts are performed. Traditionally mechanical adjusted jigs are used to accurately align and position the instruments.

Since this alignment process is a source for deviation even in experienced surgeons, several navigation systems were developed. Using these systems, the surgeon is guided in the location of the instruments with the help of a computer.

Several studies could show that the use of such a navigation system leads to an improved execution of planned axis relations, as measured on the radiographs. However, it is not clear, whether or to what extent the improved realization of the preoperative planned axis relations results in a positive effect for the patient.

This multicenter randomized clinical trail is conducted to compare the operative results of navigated and non-navigated knee replacement surgery.

The aim of this study is to evaluate the use of a navigation system on health-related quality of life, measured as pain, stiffness, physical function, coordinative abilities, and patient satisfaction.

The hypotheses tested is that the use of the navigation system for total knee arthroplasty leads to improved health-related quality of life.

Study Type

Interventional

Enrollment

477

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Charité Universitätsmedizin Berlin, Center for Musculoskeletal Surgery
      • Bremen, Germany, 28239
        • Recruiting
        • DIAKO Ev. Diakonie-Hospital gGmbH, Clinic for Orthopaedic Surgery and Traumatology
      • Hamburg, Germany, 22081
        • Not yet recruiting
        • Schön-Klinikum Hamburg-Eilbek, Department of Orthopedic Surgery and Traumatology
    • Baden-Wuerttemberg
      • Mannheim, Baden-Wuerttemberg, Germany, 68167
        • Not yet recruiting
        • University of Mannheim, Center for Orthopaedic Surgery and Traumatology
    • Bavaria
      • Bad Abbach, Bavaria, Germany, 93077
        • Suspended
        • University of Regensburg, Department of Orthopaedic Surgery
      • Würzburg, Bavaria, Germany, 97074
        • Recruiting
        • University of Würzburg, Department of Orthopaedic Surgery
    • Northrhine-Westfalia
      • Cologne, Northrhine-Westfalia, Germany, 50924
        • Not yet recruiting
        • University of Cologne, Department of Orthopaedic Surgery
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Recruiting
        • University of Schleswig-Holstein, Kiel Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients who are scheduled to receive a Total Knee Arthroplasty at the participating institutions for primary diagnosis of osteoarthritis are candidates for inclusion in the study.

Exclusion Criteria:

  • A history of septic arthritis in the joint to operate
  • Amputations
  • Neurological deficits
  • Inability to complete the questionnaires because of cognitive or language difficulties
  • Prior knee arthroplasty in the joint to operate
  • Prior arthroplasty in another weight-bearing joint within the last 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Physical functioning as measured with the Western Ontario and McMasters osteoarthritis index

Secondary Outcome Measures

Outcome Measure
Patient satisfaction
Leg-specific pain and stiffness as measured with the WOMAC
The Lequesne Knee Score
The physical component summary of the SF-36
EuroQoL-5D
Balance abilities as investigated with the Biodex Stability System®
Motoric coordination as assessed by a shortened version of the "Dortmunder modified Romberg Test for Seniors"
Proprioception assessed according to guidelines established by Barrack and Swanik
Axis relations evaluated by postoperative standardized lateral and AP X-rays

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Schleswig-Holstein

Collaborators

DePuy International

Investigators

  • Study Chair: Joachim Hassenpflug, Prof. Dr., University of Schleswig-Holstein, Kiel Medical Center
  • Principal Investigator: Thoralf R Liebs, Dr., University of Schleswig-Holstein, Kiel Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Study Completion (Anticipated)

June 1, 2009

Study Registration Dates

First Submitted

February 2, 2007

First Submitted That Met QC Criteria

February 2, 2007

First Posted (Estimate)

February 5, 2007

Study Record Updates

Last Update Posted (Estimate)

April 24, 2007

Last Update Submitted That Met QC Criteria

April 23, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCTTKR1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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