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| Name | Class |
|---|---|
| Stryker Nordic | INDUSTRY |
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Total Knee Arthroplasty (TKA) is the surgical reconstruction of the knee joint in order to relieve pain, restore function and correct deformity. It is a very common surgical procedure with figures showing more than 500'000 arthroplasties performed annually worldwide. Total knee arthroplasty is considered one of the most successful types of joint reconstruction in that surgical results usually meet and even exceed expectations. Much of the current literature focuses on the issues relating to implant wear as a potential failure mode for artificial knee implants. It has been suggested that knee with mobile or rotating bearing options, such as the comparative device proposed for this clinical investigation, may survive longer than fixed bearing knee designs because of the greater contact surface area possible with more congruent components with unconstrained, mobile component design.
This is a prospective, comparative, randomised, open-label, single center, multiple surgeons clinical study. The Scorpio PS Superflex and the Scorpio PS mobile bearing are to be implanted for evaluation in this study. Patients will be randomised to one of two equal sized groups. In the first group patients will be treated with the Scorpio PS Superflex, whilst in the second group patients will be treated with the Scorpio PS mobile bearing implant.
Evaluations consist of the KSS score, Chair rise and stair climb tests, radiology assessments, patient questionnaires, at multiple timepoints: pre-operative, 6 weeks, 3 months, 6 months 1 year, 2 years and 5 years post-operatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mobile bearing knee prosthesis | Experimental | use of the Scorpio mobile bearing knee system for total knee arthroplasty |
|
| fixed bearing | Active Comparator | use of the Scorpio fixed bearing knee system for total knee arthoplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mobile bearing knee system for total knee arthroplasty | Device |
| ||
| fixed bearing total knee prosthesis |
| Measure | Description | Time Frame |
|---|---|---|
| Anterior knee pain during stair rise | Anterior knee pain using VAS during stair rise at different follow up moments until 5 years after surgery | 5 years |
| Anterior knee pain during stair climb | Anterior knee pain using VAS during stair climb at different FU moments | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| passive and active Range of motion | measuring passive and active range of motion (flexion / extension) using a goniometer at different FU moments | 5 years |
| patella compression pain | patella compression pain at physical examination at different FU moments defined as yes of no when putting mild pressure on the patella |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Feczko, MD | orthopedic surgeon MUMC Maastricht | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28662692 | Derived | Feczko PZ, Jutten LM, van Steyn MJ, Deckers P, Emans PJ, Arts JJ. Comparison of fixed and mobile-bearing total knee arthroplasty in terms of patellofemoral pain and function: a prospective, randomised, controlled trial. BMC Musculoskelet Disord. 2017 Jun 29;18(1):279. doi: 10.1186/s12891-017-1635-9. |
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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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| Device |
|
| 5 years |
| patient satisfaction | measuring patient satisfaction using the RAND-36 questionnaire at different FU moments | 5 years |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |