None listed
Conditions
Brief summary
Study design: Prospective, single-centre, patient-blinded, non-randomised, clinical study. The study will enrol 80 patients over a 12-month recruitment period between three surgeons. Objectives: To determine the relationship between ambulation (daily step count) preoperatively/post-operatively and patient reported outcomes after total knee arthroplasty (TKA). To investigate if component alignment affects ambulation and clinical outcomes after TKA. To investigate if post-op ambulation after total knee replacement affects other parameters such as return to work and patient satisfaction. The study will also demonstrate safety, and equivalent clinical outcomes on pain and function to other published data. Group: Apex Total Knee Replacement (single study group) Number of subjects to be enrolled: 80 patients will be enrolled into this study. Medical Devices: The Apex Knee is intended for use as a primary total knee replacement device consisting of a femoral, tibial, tibial bearing and optional patellar component. The Vivofit is an activity tracker, a wrist-worn band that counts steps and monitors active time. Regulatory status: The Apex Knee is CE marked, TGA approved and has a rebate code on the Prostheses List. Clinical evaluations: Standard, functional parameters will be assessed pre-operatively, and post-operatively at 6 weeks, and 12 months. Patient outcome assessments: The Oxford Knee Score, The Knee Injury and Osteoarthritis Score (KOOS), Forgotten Joint Score and VAS satisfaction scale will be assessed pre-operatively, and post-operatively at 6 weeks, and 12 months. Radiographic evaluations: X-Rays will be assessed pre-operatively, post-operatively and at 12 months to evaluate femoral and tibial components coronal and saggital orientation. A CT-Scan will be performed preoperatively and at 6 weeks post-operatively to verify implant positioning axially.
Interventions
All patients participating in this study will be undergoing total knee replacement and receiving the Apex Total Knee Replacement
A wrist-worn activity tracker device that counts steps and monitors activity over time will be used to measure activity pre and post knee replacement surgery. X-rays and CT will be used to assess implant positioning.
Each participant will be asked to wear the Vivofit device on their wrist from about 5 weeks before your surgery to 6 weeks afterwards. Ten (10) months aft
All patients participating in this study will be undergoing total knee replacement and receiving the Apex Total Knee Replacement A wrist-worn activity tracker device that counts steps and monitors activity over time will be used to measure activity pre and post knee replacement surgery. X-rays and CT will be used to assess implant positioning. Each participant will be asked to wear the Vivofit device on their wrist from about 5 weeks before your surgery to 6 weeks afterwards. Ten (10) months after surgery, each participant will be contacted again and another Vivofit device will be sent to them to wear for 1 month prior to their 1-year postoperative assessment by their surgeon. The participant will place the wristband on as soon as they receive it. It should be worn 24 hours a day. It is waterproof so they can swim and shower normally. The internal battery will last for 12 months and after this time the participant will remove the wrist band, record the dates it was worn on the small envelope and return it to to the investigator using the self-addressed post-paid envelope provided. Before the operation, the affected knee will be assessed by x-ray and computed tomography (CT) scans in accordance with the study protocol. Each participant will also be asked to complete some simple questionnaires (Knee Injury and Osteoarthritis Score, Forgotten Joint Score, Oxford Knee Score and VAS scale) to find out how the condition of their knee affects their life before the operation and after the operation: at 6 weeks and 12 months. Each questionnaire will take only a few minutes to complete.
Sponsors
Kico Knee Innovation Pty Ltd
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with symptomatic osteoarthritis who are candidates for a primary total knee replacement with cemented tibial tray as determined jointly by the surgeon and the patient. 2. Over 18 years of age at time of surgery 3. Patients requiring an isolated single joint TKR 4. Patients living in Perth metropolitan area for logistics of follow-up 5. Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up. 6. Patient will receive a Apex Total Knee Replacement.
Exclusion criteria
1. Patients with rheumatoid arthritis 2. Medical or social conditions that may affect the patient’s ability to participate in the study or give informed consent 3. Severe hip or contralateral knee osteoarthritis that affects the patients ability to ambulate 4. Deformity of the femur or tibia
Outcome results
None listed