A Randomised Controlled Study on the Maxm Skate: A Lower Limb Rehabilitation Device for use following Total Knee Arthroplasty.

INTERVENTION: The Maxm skate is a portable, lower limb post‐operative and post‐injury rehabilitation exercise device for individual use in a hospital or home‐based setting. The Maxm Skate package is comprised of the Skate device and rope (for resistance training), sensors, iOS Application (App) and website. The Skate device is accompanied by two sensors and a mobile App which are designed to provide real time, objective data on exercise and rehabilitation progress, in particular ROM achieved, following an exercise therapy session at home. This sensor technology also enables the clinician to gather accurate compliance and ROM data (Flexion and Extension) remotely. Participants will attend a pre‐operative device education session where they will be introduced to the Maxm Skate by the physiotherapist. Participants will be given a description of the functionality, set up and safe usage of the Maxm Skate and will be given the opportunity to trial the skate. Participants will be educated on the Maxm Skate exercise program and issued an exercise booklet to familiarize themselves with the post‐operative exercise program. The Maxm Skate exercise program can be found on the following website: http://www.maxmskate.com.au/ The Maxm Skate rehabilitation device is intended to be used up to 3 months post‐surgery, however can be used for a longer duration if felt of benefit. In the inpatient acute setting the Maxm Skate group will receive the Maxm Skate in addition to standard care. Compliance with the Maxm Skate rehabilitation program will be measured using the Compliance with Rehabilitation Program Form, which collects data on number and duration of Maxm skate sessions, as well as whether additional physiotherapy has been sought. CONDITION: Degenerative Joint Disease Range of Motion Total Knee Arthroplasty PRIMARY OUTCOME: The primary outcome of this randomised controlled study is to assess the range of motion (ROM) achieved by patients whom received the Maxm Skate rehabilitation device compared with standard care, 3 months postoperatively. ; ; In a seated position, knee joint ROM in flexion and extension will be measured using a standard goniometer. SECONDARY OUTCOME: An economic evaluation assessing the relative cost effectiveness of the Maxm Skate rehabilitation device compared to standard care will be conducted. ; ; 1. The superior pole of the patella ; 2. 15cm above the superior pole of the patella ; Patients will be screened for adverse event occurrences and complications from the time of consent to 1 year postoperatively. ; ; A possible adverse event may include falls if the participant disregards explicit instruction to not stand on the Maxm Skate device. Reasoning behind misuse or other causes that led to the fall will be assessed. Quality of life will be assessed using the EQ‐5D (Level 5) measure. Satisfaction with rehabilitation will be measured on a 5‐point Likert scale ranging from ‘very unsatisfied’, ‘unsatisfied’, ‘neither satisfied nor unsatisfied’, satisfied, very satisfied. The participants state will be assessed using the Patient Acceptable Symptom State (PASS). The patient’s opinion of their knee and any other associated problems will be assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS). 2. The patient must understand the conditions of the study and be willing and able to provide written informed consent. 3. The patient is a skeletally mature male or a non‐pregnant female, 30 years of age or older. 4. The patient agrees to comply with the specified preoperative and postoperative study requirements. Patients will be consented for participation prior to TKA. ; This will be assessed by the incremental cost per unit increase in knee ROM between the 2 groups. The incremental cost per quality adjusted life year (QALY) gained over the period of the primary study and based on the EQ‐5D‐5L will also be assessed. Balance will be tested by performing a single leg stand with eyes open. The ability to maintain balance in this position is recorded in seconds. Clinical performance will be assessed using the 30s Chair‐stand test and the 4 x 10 m Fast Paced Walk Test. Isometric Knee Extensor and Flexor Strength will be measured using the MicroFET 2 Handheld Dynamometer. This will be performed in a seated position, on a box seat design with the backrest at 60 degrees and a leg ramp fixed at 45 degrees. Knee pain and function will be assessed using the Oxford Knee Score. Pain at end of range flexion and extension will be measured using a Visual Analogue Scale (VAS). Pain relief, functional abilities, satisfaction and fulfilment of expectations will be assessed using the Knee Society Score Patient’s knee and thigh circumference will measured using a regular tape measure. This will be measured at 2 points: INCLUSION CRITERIA: 1. The patient received a primary total knee arthroplasty due to non‐inflammatory degenerative joint disease (e.g. osteoarthritis and traumatic arthritis) or inflammatory joint disease (e.g. Rheumatoid Arthritis).