Functional Evaluation of a Standard and a High-flexion Knee Prosthesis Using Thigh-calf Contact Force Measurements
NCT00899041 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67
Last updated 2013-11-08
Summary
The purpose of this study is to investigate whether subjects receiving a high-flexion knee prosthesis show a better knee function than patients receiving a standard knee prosthesis. Thigh-calf contact force measurements are used to quantify knee function. The investigators' hypothesis is that high-flexion knees show a better knee function.
Conditions
- Arthroplasty, Replacement, Knee
Interventions
- PROCEDURE
-
Total Knee Arthroplasty (TKA)
28 subjects will receive the standard Sigma FB knee prosthesis. 28 subjects will receive the high flexion Sigma RP-F knee prosthesis.
Sponsors & Collaborators
-
Johnson & Johnson Medical BV, The Netherlands
collaborator UNKNOWN -
Canisius-Wilhelmina Hospital
collaborator OTHER -
Radboud University Medical Center
lead OTHER
Principal Investigators
-
Nico Verdonschot, Prof. · Radboud University Medical Center
Study Design
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-10-31
- Primary Completion
- 2013-09-30
- Completion
- 2013-10-31
Countries
- Netherlands
Study Locations
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