Trial Comparing Navigated and Conventional Implantation Techniques in Knee Replacement Surgery
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.
1 other identifier
interventional
477
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2007
Typical duration for phase_4
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 2, 2007
CompletedFirst Posted
Study publicly available on registry
February 5, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedApril 24, 2007
April 1, 2007
February 2, 2007
April 23, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Physical functioning as measured with the Western Ontario and McMasters osteoarthritis index
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Interventions
Eligibility Criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Schleswig-Holsteinlead
- DePuy Internationalcollaborator
Study Sites (8)
University of Mannheim, Center for Orthopaedic Surgery and Traumatology
Mannheim, Baden-Wurttemberg, 68167, Germany
University of Regensburg, Department of Orthopaedic Surgery
Bad Abbach, Bavaria, 93077, Germany
University of Würzburg, Department of Orthopaedic Surgery
Würzburg, Bavaria, 97074, Germany
DIAKO Ev. Diakonie-Hospital gGmbH, Clinic for Orthopaedic Surgery and Traumatology
Bremen, City state Bremen, 28239, Germany
Schön-Klinikum Hamburg-Eilbek, Department of Orthopedic Surgery and Traumatology
Hamburg, Hamburg, 22081, Germany
University of Cologne, Department of Orthopaedic Surgery
Cologne, Northrhine-Westfalia, 50924, Germany
University of Schleswig-Holstein, Kiel Medical Center
Kiel, Schleswig-Holstein, 24105, Germany
Charité Universitätsmedizin Berlin, Center for Musculoskeletal Surgery
Berlin, State of Berlin, 10117, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 2, 2007
First Posted
February 5, 2007
Study Start
January 1, 2007
Study Completion
June 1, 2009
Last Updated
April 24, 2007
Record last verified: 2007-04