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This study compares and evaluates differences in patient-reported outcome, survivorship and radiological analysis between patients undergoing total knee arthroplasty with use of either Zimmer Biomet PERSONA Posterior Stabilized (PS) system and Smith&Nephew Journey II Bi-Cruciate Stabilized (BCS) system
The aim of this study is to assess patient-reported outcome, survivorship and radiological analysis in patients after total knee arthroplasty, who will undergo the surgery with the use of either Zimmer Biomet PERSONA Posterior Stabilized (PS) system and Smith&Nephew Journey II Bi-Cruciate Stabilized (BCS) system.
To this study 45 consecutive patients undergoing total knee arthroplasty will be recruited to each group. Study protocol is designed as a prospective, blinded, parallel-group, superiority trial, with balanced randomization [1:1]. All participants will be operated in single clinical orthopedic department, by single high-volume surgeon, who performed more than 3000 total knee arthroplasties in his professional career.
Before the surgery patients will fulfill the author's questionnaire concerning their age, height and body mass, level of activity, WOMAC and KOOS scales.
1-day posteoperatively patients will undergo standard computed tomography examination to assess components placement
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PERSONA | Active Comparator | Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet PERSONA system |
|
| Journey II | Active Comparator | Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Smith&Nephew Journey II system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Knee Replacement | Device | Participant will undergo total knee replacement performed via anterior parapatellar approach with either PERSONA PS or JOURNEY II BCS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in patients reported outcome measures - KOOS Score (Knee injury and Osteoarthritis Outcome Score) | To explore differences between outcome in patients treated with use of with Journey II and Persona prosthesis. Results range from 0 to 100, with higher scores corresponding to better outcomes. | baseline (preoperatively) and 1 year postoperatively |
| Changes in patients reported outcome measures - WOMAC Score (Knee injury and Osteoarthritis Outcome Score) | To explore differences between outcome in patients treated with use of with Journey II and Persona prosthesis. Results range from 0 to 96, with higher scores corresponding to worse outcomes. | baseline (preoperatively) and 1 year postoperatively |
| Values of components rotation | Values of external or internal rotation of components measured in computed tomography postoperatively. Values in degrees in regards to anatomic bone landmarks | 1-day postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Artur Stolaerczyk, MD, PhD | Department of Orthopedics and Rehabilitation, Medical University of Warsaw | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Othopedics and Rehabilitation, Medical University of Warsaw | Warsaw | Masovian Voivodeship | 04-749 | Poland |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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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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Participant will not be informed which type of prosthesis was used in their particular case.
Outcomes Assessor, who will be not present during surgery, will not be informed which type of prosthesis was used in particular patient.
| D012216 |
| Rheumatic Diseases |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |