Patient-Focused Prognostic Tool to Evaluate Willingness for Surgery in Total Knee Arthroplasty: A Randomised Controlled Trial (The Proto Knee Trial)
- Conditions
- OsteoarthritisMusculoskeletal - Osteoarthritis
- Registration Number
- ACTRN12622000072718
- Lead Sponsor
- The University Of Melbourne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 213
Diagnosed with knee OA and are considering TKA
Considering primary and unilateral TKA
Have already trialled non-operative management for their knee symptoms
Are willing and able to use web or mobile phone based prognostic tool interfaces
Able to provide informed consent to participate and be followed up for the entire
duration of the study
Source of knee symptoms is considered to be from any cause other than knee OA e.g.
rheumatoid arthritis, hip osteoarthritis, referred lower back pain etc.
Are considering bilateral TKA, revision TKA, unicondylar knee arthroplasty (UKA),
or patellofemoral arthroplasty (PFA)
Unwilling to consider TKA despite being advised by the Orthopaedic Surgeon this
would be a reasonable management option for their knee symptoms
Prior history of septic arthritis in the affect knee
Significant bilateral knee symptoms
Intra-articular injection in the affected knee within the last 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome of this study is to evaluate the impact of the PROTO-KNEE tool use on willingness for TKA surgery for patients with knee OA. This will be measured with a binary question are your knee symptoms so bothersome that you would be willing to undergo surgery if medically fit to do so? (Yes/No)[6 weeks, 12 weeks, and 6 months after using the PROTO-KNEE tool]
- Secondary Outcome Measures
Name Time Method