Degenerative Joint Disease of the Knee, Knee Osteoarthritis
Conditions
Keywords
Robotic-Assisted Total Knee Arthroplasty, VELYS System, Kinematic Alignment, functional Alignment, Medial Stabilized Insert, Cruciate Retaining Insert, Patient-Reported Outcomes, Total Knee Replacement
Brief summary
This study aims to evaluate patient outcomes following robotic-assisted total knee arthroplasty using the VELYS system. Patients undergoing surgery will receive either kinematic alignment or functional alignment as determined by the operating surgeon as part of routine clinical care. Within each surgical technique group, patients will be randomly assigned to receive different implant insert types (medial stabilised or cruciate retaining) using a REDCap-based randomisation process. Patient-reported outcome measures will be collected before surgery and at follow-up time points after surgery to assess clinical outcomes.
Detailed description
This is a prospective interventional study evaluating outcomes in patients undergoing robotic-assisted total knee arthroplasty using the VELYS system. The study includes patients treated using either kinematic alignment or functional alignment techniques, which are determined by the operating surgeon based on clinical practice and are not randomized as part of the study protocol. Within each alignment group, participants are randomized to receive one of two implant insert types: medial stabilised (MS) or cruciate retaining (CR). Randomisation is performed using a REDCap-based allocation system. The primary objective of the study is to assess patient-reported outcomes following surgery. Secondary outcomes may include clinical and functional measures collected at predefined time points, including pre-operative and post-operative follow-up visits. This study reflects real-world clinical practice while incorporating a randomized component for implant selection. The design allows for evaluation of both implant-related outcomes and comparisons across different alignment techniques, while maintaining clarity regarding which aspects of the intervention are randomized.
Interventions
DEVICEMedial Stabilized Insert
A medial stabilised polyethylene insert used in robotic-assisted total knee arthroplasty to provide enhanced stability during knee motion.
DEVICECruciate Retaining Insert
A cruciate retaining polyethylene insert used in robotic-assisted total knee arthroplasty that preserves the posterior cruciate ligament.
Sponsors
Singapore General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants receive either kinematic or functional alignment based on the operating surgeon as part of routine clinical care. Within each alignment group, participants are randomized to receive one of two implant insert types (medial stabilised or cruciate retaining) using a REDCap-based allocation process.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\*Inclusion Criteria:\* * Patients undergoing robotic-assisted total knee arthroplasty using the VELYS system * Diagnosis of knee osteoarthritis requiring surgical intervention * Able to provide informed consent * Willing to complete patient-reported outcome measures \*\*
Exclusion criteria
\*\* * Patients undergoing revision knee arthroplasty * Presence of active infection * Inability to comply with follow-up assessments * Severe co-morbidities that may affect surgical outcomes or participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Forgotten Joint Score (FJS) | Pre-operative, 6 weeks, 6 months, and 2 years post-operatively | Forgotten Joint Score (FJS) The Forgotten Joint Score (FJS) is a patient-reported outcome measure assessing joint awareness in daily life following total knee arthroplasty. The score ranges from 0 to 100, with higher scores indicating better outcomes (less joint awareness). |
Countries
Singapore
Outcome results
None listed