Functional Evaluation of a Standard and a High-flexion Knee Prosthesis Using Thigh-calf Contact Force Measurements
NCT ID: NCT00899041
Last Updated: 2013-11-08
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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COMPLETED
NA
67 participants
INTERVENTIONAL
2008-10-31
2013-10-31
Brief Summary
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Detailed Description
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Functional evaluation of a standard and a high-flexion knee prosthesis using thigh-calf contact force measurements.
Objective:
The objective of this study is to investigate whether subjects receiving a high flexion knee prosthesis (Sigma RP-F, J\&J, UK) show a better knee function than patients receiving a standard knee prosthesis (Sigma FB, J\&J, UK).
Study Design:
Prospective double blind randomized study.
Study population:
Subjects who will receive total knee arthroplasty (TKA) because of invalidating gonarthritis based on primary osteoarthritis or rheumatic disorders or trauma.
Intervention:
* 28 subjects will receive the standard Sigma FB knee prosthesis.
* 28 subjects will receive the high flexion Sigma RP-F knee prosthesis.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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Standard knee prosthesis
'standard' knee prosthesis (Sigma FB, J\&J, UK).
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.
High flexion knee prosthesis
'high flexion' knee prosthesis (Sigma RP-F, J\&J, UK).
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Primary due to osteo-arthritis
* Secondary due to rheumatoid arthritis or trauma
Exclusion Criteria
* Patients suffering from hemophilia
* Patients that are incapable to give informed consent
* Patients who receive a total knee replacement due to an oncological resection
* Patients who have received a total knee replacement on the contralateral leg
* Patients who have disabling gonarthrosis on both legs
* Patients having a BMI \< 25 kg/m\^2
* Patients who have to receive a different prosthesis than used in this study for biomechanical reasons (e.g. revision prosthesis)
ALL
No
Sponsors
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Johnson & Johnson Medical BV, The Netherlands
UNKNOWN
Canisius-Wilhelmina Hospital
OTHER
Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Nico Verdonschot, Prof.
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Canisius-Wilhelmina Hospital
Nijmegen, , Netherlands
Countries
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References
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Zelle J, Barink M, Loeffen R, De Waal Malefijt M, Verdonschot N. Thigh-calf contact force measurements in deep knee flexion. Clin Biomech (Bristol). 2007 Aug;22(7):821-6. doi: 10.1016/j.clinbiomech.2007.03.009. Epub 2007 May 18.
van der Ven PJP, van de Groes S, Zelle J, Koeter S, Hannink G, Verdonschot N. Kneeling and standing up from a chair as performance-based tests to evaluate knee function in the high-flexion range: a randomized controlled trial comparing a conventional and a high-flexion TKA design. BMC Musculoskelet Disord. 2017 Aug 1;18(1):324. doi: 10.1186/s12891-017-1657-3.
Other Identifiers
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ORL-FK-08/02
Identifier Type: -
Identifier Source: org_study_id