Comparison of the Persona Medial Congruent Retained Posterior-Cruciate Ligament vs. Persona Posterior-stabilized vs. NexGen Posterior-Stabilized Total Knee Arthroplasty a Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Changes in patients reported outcome measures - Oxford Knee Score (OKS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, 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 Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Listed for a primary total knee replacement (TKR) at the Orthopaedic and Rehabilitation Department Medical University of Warsaw
- •Indication for the TKR is primary osteoarthritis of the knee joint involving one or more compartments
- •Aged 18 or over
- •Patient willing to provide full informed consent to the trial
Exclusion Criteria
- •Listed for a single-stage bilateral TKR procedure
- •Severe symptoms in the contralateral knee so as to require staged bilateral knee replacements within 6 months of the primary procedure
- •Fixed flexion deformity of 15 degrees or greater who will require excessive resection of the distal femur
- •Clinically assessed uncorrectable varus/valgus deformity of 15 degrees or greater
- •Any co-morbidity which, in the opinion of the investigator, is severe enough to present an unacceptable risk to the patient's safety
- •Inflammatory arthritis
- •Previous septic arthritis in the affected knee joint
- •Previous surgery to the collateral ligaments of the affected knee
- •A contralateral total knee replacement that has been implanted less than one year from the date of consultation
- •A contralateral total knee replacement that is severely painful
- •Patients on warfarin or novel oral anticoagulants (NOACs)
- •Will not be resident in the catchment area for at least 6 months post-surgery
- •Undertaking the surgery as a private patient
- •Patients who, in the opinion of the clinical staff, do not have capacity to consent
- •Patients who are pregnant
- •Unable to understand written and spoken Polish
Arms & Interventions
NexGen
Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet NexGen prosthesis
Intervention: Total knee replacement (Procedure)
NexGen
Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet NexGen prosthesis
Intervention: CT scan (Diagnostic Test)
NexGen
Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet NexGen prosthesis
Intervention: Biomechanics (Diagnostic Test)
NexGen
Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet NexGen prosthesis
Intervention: one of the Persona MC Retained PCL, Persona MC Sacrificed PCL and NexGen PS total knee implant (Device)
Persona MC Retained PCL
Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet Persona MC Retained PCL prosthesis
Intervention: Total knee replacement (Procedure)
Persona MC Retained PCL
Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet Persona MC Retained PCL prosthesis
Intervention: CT scan (Diagnostic Test)
Persona MC Retained PCL
Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet Persona MC Retained PCL prosthesis
Intervention: Biomechanics (Diagnostic Test)
Persona MC Retained PCL
Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet Persona MC Retained PCL prosthesis
Intervention: one of the Persona MC Retained PCL, Persona MC Sacrificed PCL and NexGen PS total knee implant (Device)
Persona MC Sacrificed PCL
Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet Persona MC Sacrificed PCL prosthesis
Intervention: Total knee replacement (Procedure)
Persona MC Sacrificed PCL
Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet Persona MC Sacrificed PCL prosthesis
Intervention: CT scan (Diagnostic Test)
Persona MC Sacrificed PCL
Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet Persona MC Sacrificed PCL prosthesis
Intervention: Biomechanics (Diagnostic Test)
Persona MC Sacrificed PCL
Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet Persona MC Sacrificed PCL prosthesis
Intervention: one of the Persona MC Retained PCL, Persona MC Sacrificed PCL and NexGen PS total knee implant (Device)
Outcomes
Primary Outcomes
Changes in patients reported outcome measures - Oxford Knee Score (OKS)
Time Frame: 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 Outcomes
- Changes in patients reported outcomes - EuroQol (EQ- 5D-5L)(1 week, 6-8 weeks and 6 months post- operatively)
- Radiological outcome on CT scans(at baseline preoperatively and 6-months postoperatively)
- 6- minute walking abilities(6-8 weeks and 6 months post-operatively)
- Biomechanical stair climbing outcomes(at baseline, 6-8 weeks and 6 months post-operatively)
- Changes in patients reported outcome measures - Oxford Knee Score (OKS)(1 week and 6-8 weeks post-operatively)
- Changes in patients reported outcomes - Oxford Knee Score Activity & Participation Questionnaire (OKS_APQ)(1 week, 6-8 weeks and 6 months post- operatively)
- Changes in patients reported outcomes - Forgotten Joint Score (FJS)(6-8 weeks and 6 months post-operatively)
- Changes in patients reported outcomes - UCLA (University of California) score(6-8 weeks and 6 months post-operatively)
- Changes in knee range of motion(preoperatively, 6-8 weeks and 6 months post-operatively)
- Changes in pain medication(1 week, 6-8 weeks and 6 months post-operatively)
- arthroplasty related complications(1 week, 6-8 weeks and 6 months post-operatively)
- arthroplasty revision surgeries(1 week, 6-8 weeks and 6 months post-operatively)
- walking abilities(6-8 weeks and 6 months post-operatively)
- Length of hospital stay(from baseline to discharge from hospital ranging averagely from 1 up to 7 days postoperatively)
- Biomechanical 3D miotion and emg walking outcomes(at baseline, 6-8 weeks and 6 months post-operatively)
- Biomechanical static balance outcomes(at baseline, 6-8 weeks and 6 months post-operatively)
- Biomechanical dynamic balance outcomes(at baseline, 6-8 weeks and 6 months post-operatively)
- Leg muscle strength outcomes(at baseline, 6-8 weeks and 6 months post-operatively)
Investigators
Artur Stolarczyk
Head of the Department of Orthopedic and Rehabilitation
Medical University of Warsaw