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| Name | Class |
|---|---|
| Johnson & Johnson Medical BV, The Netherlands | UNKNOWN |
| Canisius-Wilhelmina Hospital | OTHER |
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.
Study title:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard knee prosthesis | Active Comparator | 'standard' knee prosthesis (Sigma FB, J&J, UK). |
|
| High flexion knee prosthesis | Active Comparator | 'high flexion' knee prosthesis (Sigma RP-F, J&J, UK). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Knee Arthroplasty (TKA) | Procedure | 28 subjects will receive the standard Sigma FB knee prosthesis. 28 subjects will receive the high flexion Sigma RP-F knee prosthesis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Thigh-calf contact force | pre-op and 1-year post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Passive/active maximal knee flexion angle | pre-op and 1-year post-op | |
| BMI, weight and length | pre-op and 1-year post-op | |
| Thigh and calf circumference |
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Inclusion Criteria:
Patients receiving a total knee replacement due to disabling gonarthrosis (cartilage damage):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nico Verdonschot, Prof. | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canisius-Wilhelmina Hospital | Nijmegen | 6532 SZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17512647 | Background | 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. | |
| 28764691 | Derived | 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. |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| pre-op and 1-year post-op |
| IKS, WOMAC and VAS (pain/satisfaction) score | pre-op and 1-year post-op |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |