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Trial Comparing Navigated and Conventional Implantation Techniques in Knee Replacement Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00431509
Recruitment Status : Unknown
Verified April 2007 by University of Schleswig-Holstein.
Recruitment status was:  Recruiting
First Posted : February 5, 2007
Last Update Posted : April 24, 2007
DePuy International
Information provided by:
University of Schleswig-Holstein

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Procedure: conventional vs. navigated total knee arthroplasty Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 477 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
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.
Study Start Date : January 2007
Estimated Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00431509

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Contact: Thoralf R Liebs, Dr. +49 431 597 ext 2444

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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
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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

Layout table for additonal information Identifier: NCT00431509    
Other Study ID Numbers: RCTTKR1
First Posted: February 5, 2007    Key Record Dates
Last Update Posted: April 24, 2007
Last Verified: April 2007
Keywords provided by University of Schleswig-Holstein:
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases