Joint; Arthrosis, Primary, Knee Arthritis, Knee Osteoarthritis
Conditions
Keywords
Total Knee Arthroplasty, Nexgen, Persona, Knee osteoarthritis
Brief summary
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
Detailed description
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.
Interventions
PROCEDURETotal knee replacement
Participant will undergo total knee replacement performed via anterior parapatellar approach with either Posterior Cruciate Ligament sacrificing or retaining implant
DIAGNOSTIC_TESTCT scan
CT scans of the affected knee joint before and after the surgical procedure
DIAGNOSTIC_TESTBiomechanics
Participants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively
DEVICEone of the Persona MC Retained PCL, Persona MC Sacrificed PCL and NexGen PS total knee implant
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.
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Listed for a primary total knee replacement (TKR) at the Orthopaedic and Rehabilitation Department Medical University of Warsaw 2. Indication for the TKR is primary osteoarthritis of the knee joint involving one or more compartments 3. Aged 18 or over 4. Patient willing to provide full informed consent to the trial
Exclusion criteria
1. Listed for a single-stage bilateral TKR procedure 2. Severe symptoms in the contralateral knee so as to require staged bilateral knee replacements within 6 months of the primary procedure 3. Fixed flexion deformity of 15 degrees or greater who will require excessive resection of the distal femur 4. Clinically assessed uncorrectable varus/valgus deformity of 15 degrees or greater 5. Any co-morbidity which, in the opinion of the investigator, is severe enough to present an unacceptable risk to the patient's safety 6. Inflammatory arthritis 7. Previous septic arthritis in the affected knee joint 8. Previous surgery to the collateral ligaments of the affected knee 9. A contralateral total knee replacement that has been implanted less than one year from the date of consultation 10. A contralateral total knee replacement that is severely painful 11. Patients on warfarin or novel oral anticoagulants (NOACs) 12. Will not be resident in the catchment area for at least 6 months post-surgery 13. Undertaking the surgery as a private patient 14. Patients who, in the opinion of the clinical staff, do not have capacity to consent 15. Patients who are pregnant 16. Unable to understand written and spoken Polish
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in patients reported outcome measures - Oxford Knee Score (OKS) | baseline (preoperatively) and 6-months postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in patients reported outcomes - Oxford Knee Score Activity & Participation Questionnaire (OKS_APQ) | 1 week, 6-8 weeks and 6 months post- operatively | To explore differences in higher levels of activity and social participation |
| Changes in patients reported outcomes - EuroQol (EQ- 5D-5L) | 1 week, 6-8 weeks and 6 months post- operatively | To explore differences in quality of life |
| Changes in patients reported outcomes - Forgotten Joint Score (FJS) | 6-8 weeks and 6 months post-operatively | 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. |
| Changes in patients reported outcomes - UCLA (University of California) score | 6-8 weeks and 6 months post-operatively | To explore differences in patient's physical activity. Results range from 0 to 10, with higher scores corresponding to better outcomes. |
| Changes in knee range of motion | preoperatively, 6-8 weeks and 6 months post-operatively | To explore differences in range of motion (flexion and extension) |
| Changes in pain medication | 1 week, 6-8 weeks and 6 months post-operatively | To asses evolution of post-operative knee pain |
| arthroplasty related complications | 1 week, 6-8 weeks and 6 months post-operatively | To count and asses all complications that may occur during surgery and in postoperative period |
| arthroplasty revision surgeries | 1 week, 6-8 weeks and 6 months post-operatively | To count and asses the reason of all revision surgeries that may occur during postoperative period |
| Changes in patients reported outcome measures - Oxford Knee Score (OKS) | 1 week and 6-8 weeks post-operatively | 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. |
| Length of hospital stay | from baseline to discharge from hospital ranging averagely from 1 up to 7 days postoperatively | To measure number of days counting from surgery to the discharge |
| Biomechanical 3D miotion and emg walking outcomes | at baseline, 6-8 weeks and 6 months post-operatively | Overground walking is measured using 3D Motion analysis and electromyography (EMG) |
| Radiological outcome on CT scans | at baseline preoperatively and 6-months postoperatively | 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) |
| 6- minute walking abilities | 6-8 weeks and 6 months post-operatively | to asses pace and model of 6-minute walk |
| Biomechanical stair climbing outcomes | at baseline, 6-8 weeks and 6 months post-operatively | Stair climbing and descending is measured using 3D Motion analysis and EMG |
| Biomechanical static balance outcomes | at baseline, 6-8 weeks and 6 months post-operatively | Static balance is measured using a force plate |
| Biomechanical dynamic balance outcomes | at baseline, 6-8 weeks and 6 months post-operatively | Dynamic balance is measured using a force plate and the modified Star Excursion Balance Test (mSEBT) |
| Leg muscle strength outcomes | at baseline, 6-8 weeks and 6 months post-operatively | Leg muscle strength measured using maximal voluntary isometric contraction (MVIC) test of the hamstring and quadriceps muscles on both limbs. |
| walking abilities | 6-8 weeks and 6 months post-operatively | To asses up and go time |
Countries
Poland
Contacts
Primary ContactBartosz Maciąg, MD
Outcome results
None listed