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This study compares and evaluates differences in movement analysis, patient-reported outcome and radiological assesment between patients undergoing total knee arthroplasty with use of either Zimmer Biomet NexGen and Zimmer Biomet PERSONA
Osteoarthritis causes the joints to become painful and stiff. Osteoarthritis of the knee is a common condition that is expected to be a lot more frequent in the next two decades. As a consequence, an increase of total knee replacement surgery is predicted. Total knee replacement surgery is offered when knee pain and stiffness caused by osteoarthritis can no longer be managed and these symptoms significantly impact on an individual's normal activities of daily living. Most total knee replacements are successful but up to 34% of all patients have poor functional outcomes following surgery. This leaves affected people at a greater risk of reduced physical activity and thus impacts longer-term general health. Poor outcomes are therefore of importance to patients and have a considerable financial and service-provision impact on National Health Service (NHS) care. While patient-related characteristics and their relationship to patient outcomes have been identified, few studies have been undertaken to determine how kinematic outcomes (how the prosthetic knee moves) are related to functional outcome and patient satisfaction. The kinematic outcome of a total knee replacement is hypothesised to relate to both the structural design (shape) of the implant and the surgical procedure itself. To date, no studies have investigated the kinematic outcomes of different total knee replacement prosthesis designs through a range of typical activities of everyday mobility (functional outcomes). Whilst it is known that long term success of total knee replacement depends largely upon correct alignment of the prosthesis components during surgery, no studies have looked at the anatomical alignments of the osteoarthritic knee prior to undergoing surgery (using Computerised Tomography (CT) scanning). The aim of the study is to examine relationships between movement analysis (kinematic and functional outcomes), patient reported outcome measures (PROMS) and CT measurement, both pre- and post-operatively, between two knee prosthesis including one that has been designed to improve functional outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NexGen | Active Comparator | Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet NexGen prosthesis |
|
| Persona MC Retained PCL | Active Comparator | Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet Persona MC Retained PCL prosthesis |
|
| Persona MC Sacrificed PCL | Active Comparator | Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet Persona MC Sacrificed PCL prosthesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total knee replacement | Procedure | Participant will undergo total knee replacement performed via anterior parapatellar approach with either Posterior Cruciate Ligament sacrificing or retaining implant |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in patients reported outcome measures - Oxford Knee Score (OKS) | To explore differences between outcome in patients treated with use of with Nexgen and Persona prosthesis. Results range from 0 to 48, with higher scores corresponding to better outcomes. | baseline (preoperatively) and 6-months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in patients reported outcome measures - Oxford Knee Score (OKS) | To explore differences between outcome in patients treated with use of with Nexgen and Persona prosthesis. Results range from 0 to 48, with higher scores corresponding to better outcomes. | 1 week and 6-8 weeks post-operatively |
| Changes in patients reported outcomes - Oxford Knee Score Activity & Participation Questionnaire (OKS_APQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bartosz Maciąg, MD | Contact | 881568144 | 0048 | bartosz.maciag94@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Artur Stolarczyk, PhD | Medical University of Warsaw | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Othopedics and Rehabilitation, Medical University of Warsaw | Recruiting | Warsaw | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37491199 | Derived | Maciag BM, Kordyaczny T, Jegierski D, Lapinski M, Dorocinska M, Zarnovsky K, Maciag GJ, Adamska O, Stolarczyk A. Differences in joint line level and posterior condylar offset during total knee replacement with use of gap-balancing and measured resection techniques-matched cohort study. BMC Musculoskelet Disord. 2023 Jul 25;24(1):610. doi: 10.1186/s12891-023-06722-1. |
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Participant will not be informed which type of prosthesis was used in their particular case.
Outcomes Assessor will not be informed which type of prosthesis was used in particular patient.
| CT scan | Diagnostic Test | CT scans of the affected knee joint before and after the surgical procedure |
|
| Biomechanics | Diagnostic Test | Participants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively |
|
| one of the Persona MC Retained PCL, Persona MC Sacrificed PCL and NexGen PS total knee implant | Device | Participant are randomly allocated to receive one of the Persona MC Retained PCL, Persona MC Sacrificed PCL and the NexGen PS total knee implant for treatment of end-stage knee osteoarthritis. |
|
To explore differences in higher levels of activity and social participation |
| 1 week, 6-8 weeks and 6 months post- operatively |
| Changes in patients reported outcomes - EuroQol (EQ- 5D-5L) | To explore differences in quality of life | 1 week, 6-8 weeks and 6 months post- operatively |
| Changes in patients reported outcomes - Forgotten Joint Score (FJS) | To explore differences in patient's ability to forget about a joint as a result of successful treatment. Results range from 0 to 100, with higher scores corresponding to better outcomes. | 6-8 weeks and 6 months post-operatively |
| Changes in patients reported outcomes - UCLA (University of California) score | To explore differences in patient's physical activity. Results range from 0 to 10, with higher scores corresponding to better outcomes. | 6-8 weeks and 6 months post-operatively |
| Changes in knee range of motion | To explore differences in range of motion (flexion and extension) | preoperatively, 6-8 weeks and 6 months post-operatively |
| Changes in pain medication | To asses evolution of post-operative knee pain | 1 week, 6-8 weeks and 6 months post-operatively |
| arthroplasty related complications | To count and asses all complications that may occur during surgery and in postoperative period | 1 week, 6-8 weeks and 6 months post-operatively |
| arthroplasty revision surgeries | To count and asses the reason of all revision surgeries that may occur during postoperative period | 1 week, 6-8 weeks and 6 months post-operatively |
| walking abilities | To asses "up and go" time | 6-8 weeks and 6 months post-operatively |
| Length of hospital stay | To measure number of days counting from surgery to the discharge | from baseline to discharge from hospital ranging averagely from 1 up to 7 days postoperatively |
| Biomechanical 3D miotion and emg walking outcomes | Overground walking is measured using 3D Motion analysis and electromyography (EMG) | at baseline, 6-8 weeks and 6 months post-operatively |
| Radiological outcome on CT scans | Rotational alignment of the total knee component is assessed by measuring the femoral antetorsion, Alignment of the total knee component is assessed by measuring the tibial tubercle-trochlear groove distance (TT-TG) | at baseline preoperatively and 6-months postoperatively |
| 6- minute walking abilities | to asses pace and model of 6-minute walk | 6-8 weeks and 6 months post-operatively |
| Biomechanical stair climbing outcomes | Stair climbing and descending is measured using 3D Motion analysis and EMG | at baseline, 6-8 weeks and 6 months post-operatively |
| Biomechanical static balance outcomes | Static balance is measured using a force plate | at baseline, 6-8 weeks and 6 months post-operatively |
| Biomechanical dynamic balance outcomes | Dynamic balance is measured using a force plate and the modified Star Excursion Balance Test (mSEBT) | at baseline, 6-8 weeks and 6 months post-operatively |
| Leg muscle strength outcomes | Leg muscle strength measured using maximal voluntary isometric contraction (MVIC) test of the hamstring and quadriceps muscles on both limbs. | at baseline, 6-8 weeks and 6 months post-operatively |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| D014057 | Tomography, X-Ray Computed |
| D001696 | Biomechanical Phenomena |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D014054 | Tomography |
| D055592 | Biophysical Phenomena |
| D055585 | Physical Phenomena |
| D055595 | Mechanical Phenomena |
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