Trial Comparing Navigated and Conventional Implantation Techniques in Knee Replacement Surgery
NCT ID: NCT00431509
Last Updated: 2007-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
477 participants
INTERVENTIONAL
2007-01-31
2009-06-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Interventions
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conventional vs. navigated total knee arthroplasty
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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DePuy International
INDUSTRY
University Hospital Schleswig-Holstein
OTHER
Principal Investigators
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Joachim Hassenpflug, Prof. Dr.
Role: STUDY_CHAIR
University of Schleswig-Holstein, Kiel Medical Center
Thoralf R Liebs, Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Schleswig-Holstein, Kiel Medical Center
Locations
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University of Mannheim, Center for Orthopaedic Surgery and Traumatology
Mannheim, Baden-Wurttemberg, Germany
University of Regensburg, Department of Orthopaedic Surgery
Bad Abbach, Bavaria, Germany
University of Würzburg, Department of Orthopaedic Surgery
Würzburg, Bavaria, Germany
DIAKO Ev. Diakonie-Hospital gGmbH, Clinic for Orthopaedic Surgery and Traumatology
Bremen, City state Bremen, Germany
Schön-Klinikum Hamburg-Eilbek, Department of Orthopedic Surgery and Traumatology
Hamburg, City state of Hamburg, Germany
University of Cologne, Department of Orthopaedic Surgery
Cologne, Northrhine-Westfalia, Germany
University of Schleswig-Holstein, Kiel Medical Center
Kiel, Schleswig-Holstein, Germany
Charité Universitätsmedizin Berlin, Center for Musculoskeletal Surgery
Berlin, State of Berlin, Germany
Countries
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Central Contacts
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Other Identifiers
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RCTTKR1
Identifier Type: -
Identifier Source: org_study_id