Trial Comparing Navigated and Conventional Implantation Techniques in Knee Replacement Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by University of Schleswig-Holstein.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
DePuy International
Information provided by:
University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT00431509
First received: February 2, 2007
Last updated: April 23, 2007
Last verified: April 2007
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Procedure: conventional vs. navigated total knee arthroplasty
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • Physical functioning as measured with the Western Ontario and McMasters osteoarthritis index

Secondary Outcome Measures:
  • Leg-specific pain and stiffness as measured with the WOMAC
  • The Lequesne Knee Score
  • The physical component summary of the SF-36
  • EuroQoL-5D
  • Patient satisfaction
  • 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

Estimated Enrollment: 477
Study Start Date: January 2007
Estimated Study Completion Date: June 2009
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00431509

Contacts
Contact: Thoralf R Liebs, Dr. +49 431 597 ext 2444 liebs@orthop.uni-kiel.de

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00431509     History of Changes
Other Study ID Numbers: RCTTKR1
Study First Received: February 2, 2007
Last Updated: April 23, 2007
Health Authority: Germany: Ethics Commission

Keywords provided by University of Schleswig-Holstein:
Osteoarthritis
Arthroplasty
Replacement
Knee
Instrumentation

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 16, 2014