None listed
Conditions
Brief summary
The purpose of this registry is to compare the clinical outcomes of primary total hip, total knee and partial knee arthroplasty patients operated with Mako and non-Mako techniques. Outcome data entered by patients will be collected electronically via an app (called myrecovery) or websurvey link. The secondary purpose is to monitor the early use of this platform (in terms of questionnaire completion rates achievable with the app) that is expected to aid in the data collection process and ultimately achieve high dataset completion rates. Patients will be recruited (retrospectively and prospectively) across Australian sites and data will be collected pre-operatively, peri-operatively and at 6-weeks, 3-months, 6-months, 1-year and 2-years post-operatively with a minimum of 500 patients at 1-year and 250 patients at 2-years (across all procedures). Retrospective patients provided consent to the collection of their data in the same way as prospective patients via the myrecovery app, after being invited to use the app by their surgeon. This took place at the time of their pre-operative visit and patients had time to consider and ask questions. Thus, for the use of their Data in this registry a waiver of consent may be applied.
Interventions
Either total knee, partial knee or total hip arthroplasty operated with the Stryker Mako Robotic-Arm Assisted Technology. No specific intervention (i.e. implant choice) is prescribed. Surgeons are to follow their usual stand of care pathway and collect outcome data on patients. Such data consists of patient questionnaires and objective activity level data only and is to be collected via an electronic platform, called myrecovery. Myrecovery is an app that collects health outcomes. In the clinic w
Either total knee, partial knee or total hip arthroplasty operated with the Stryker Mako Robotic-Arm Assisted Technology. No specific intervention (i.e. implant choice) is prescribed. Surgeons are to follow their usual stand of care pathway and collect outcome data on patients. Such data consists of patient questionnaires and objective activity level data only and is to be collected via an electronic platform, called myrecovery. Myrecovery is an app that collects health outcomes. In the clinic when patients are invited to the registry the surgeon will provide information on how to download the myrecovery app. Questionnaires are then made available at specific timepoints for patients to complete. In addition to these questionnaires, participants may opt-in to schedule exercise. As such, interaction with the app will vary between patients and no set frequency/length of app interaction is prescribed. Participant adherence to the app will not be monitored throughout the study but will instead be analysed at the time of data analysis by accessing data exported from the myrecovery app. This app platform does not alter treatment plan. The joint arthroplasty procedures included in this registry will be administered by a physician wherein the expected duration of surgery is approximately 1.5 hours.
Sponsors
Stryker Australia Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient has undergone or is to undergo a THA, TKA or PKA executed or to be executed via Mako or non-Mako techniques 2. Patient is a skeletally mature male or skeletally mature non-pregnant female aged 21 years or older at the time of consent 3. Patient has completed or is willing to complete the HREC-approved consent sign off via the myrecovery app
Exclusion criteria
1. Patient has a cognitive impairment, an intellectual disability or a mental illness that is thought by the Investigator to impact on their ability to comply with the requirements of the study 2. Patient is unwilling to complete the consent sign off via the myrecovery app 3. Patient has had revision/reconstruction of THA, TKA or PKA. Only primary surgeries will be included in this registry.
Outcome results
None listed