Post-market, monocentric, randomised, open-label, parallel group, prospective study conducted in patients who have to perform a total knee replacement (TKR) with Physica KR or Physica CR system.
The aim of the study is to evaluate the clinical, radiographic and PROMs outcomes of Total Knee Arthroplasty (TKA) with 2 Lima TKR design: Physica KR and Physica CR (randomization 1:1) from preoperative to 1-year follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
modular knee prosthesis with a Kinematic Retaining (KR) mechanism and posterior cruciate ligament (PCL) preservation
modular knee prosthesis with posterior cruciate ligament (PCL) preservation
The Royal Bournemouth Hospital
Bournemouth, Dorset, United Kingdom
Oxford Knee Score (OKS)
Changes of the Oxford Knee Score (OKS) from preoperative (baseline) to 1 year after the implant of the Physica KR compared to Physica CR designs. Specifically designed and developed to assess function and pain after TKR surgery. Responses to each question ranges from 0-4 with a range of a possible overall score from 0-48. A score of 0 is the worst possible outcome while a score of 48 is the best possible outcome.
Time frame: Baseline to 1 year FU
30-second Chair Stand Test (30 CST)
Functional changes in 30-second Chair Stand Test (30 CST) from pre-operative (baseline) to 1 year after the implant of the Physica KR compared to Physica CR designs.
Time frame: Baseline to 1 year FU
40 metre fast paced walk test
Functional changes in 40 metre fast paced walk test from preoperative (baseline) to 1 year after the implant of the Physica KR compared to Physica CR designs.
Time frame: Baseline to 1 year FU
Knee injury and Osteoarthritis Outcome Score (KOOS)
Changes in the Knee injury and Osteoarthritis Outcome Score (KOOS) from pre-operative (baseline) to 1 year after the implant of the Physica KR compared to Physica CR designs. KOOS is a 42-item self-administered self-explanatory questionnaire that covers five patient-relevant dimensions: Pain, Other Disease-Specific Symptoms, Active Daily Living Function, Sport and Recreation Function, and knee-related Quality of Life. A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems
Time frame: Baseline to 1 year FU
Medical Outcomes Survey Short Form-36 (SF-36) RAND SF-36
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Changes in 36-Item Short Form Health Survey (SF-36) outcome from pre-operative (baseline) to 1 year after the implant. This questionnaire includes 8 scales of differing domains of health: physical functioning, bodily pain, role-physical, general health, vitality, role emotional, social functioning, and mental health. Each scale is scored on a 0 to 100 scale with a 100 representing the best score possible.
Time frame: Baseline to 1 year FU
Forgotten Joint Score (FJS)
Changes in the Forgotten Joint Score (FJS) from pre-operative (baseline) to 1 year after the implant of the Physica KR compared to Physica CR designs. It comprises measures for the assessment of joint-specific patient-reported outcome and focus on patients' awareness of a specific joint in everyday life. It consists of 12 questions and is scored using a 5-point Likert response format (never-almost never-seldom- sometimes-mostly) with the raw scores transformed onto a 0-100 point scale. High scores indicate good outcome.
Time frame: Baseline to 1 year FU
Range of Motion (ROM)
Changes in the Range of Motion (ROM) from pre-operative (baseline) to 1 year after the implant of the Physica KR compared to Physica CR designs.
Time frame: Baseline to 1 year FU
Knee Society Score (KSS)
Changes in the Knee Society Score (KSS) from pre-operative (baseline) to 1 year after the implant of the Physica KR compared to Physica CR designs. KSS is divided into two components to assess the knee clinically through the physical examination, and to assess the individual's functionality . The maximum score of 100 points that is the best outcome.
Time frame: Baseline to 1 year FU
Radiographic evaluation
Radiographic implant evaluation and stability assessment of the Physica KR compared to Physica CR designs at baseline and 1 year after the implant.
Time frame: Baseline to 1 year FU
Serious Adverse Event (SAE) incidence
Changes Incidence, type and severity of all device-related Serious Adverse Events (SAEs) at intra-operatively, at discharge, 6 months and 1 year after the implant.
Time frame: Baseline to 1 year FU
Adverse Event (AE) device related incidence
Incidence, type and severity of all device-related Adverse Events (AEs) at intraoperatively, at discharge, 6 months and 1 year after the implant
Time frame: Baseline to 1 year FU