An interventional study of Medial Stabilized Insert and Cruciate Retaining Insert in Knee Osteoarthritis and Degenerative Joint Disease of the Knee, sponsored by Singapore General Hospital. Recruiting at 1 site in Singapore. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Singapore General Hospital · Not applicable, Interventional, and Treatment
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.
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.
3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.
This study's planned enrollment of 240 is above the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Singapore General Hospital is the lead sponsor of 266 studies on the registry; 57 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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*Inclusion Criteria:*
**Exclusion Criteria:**
Patients undergoing kinematic alignment with medial stabilised insert in robotic-assisted total knee arthroplasty.
Device: Medial Stabilized Insert
Patients undergoing kinematic alignment with cruciate retaining insert in robotic-assisted total knee arthroplasty
Device: Cruciate Retaining Insert
Patients undergoing functional alignment with medial stabilised insert in robotic-assisted total knee arthroplasty.
Device: Medial Stabilized Insert
Patients undergoing functional alignment with cruciate retaining insert in robotic-assisted total knee arthroplasty
Device: Cruciate Retaining Insert
A medial stabilised polyethylene insert used in robotic-assisted total knee arthroplasty to provide enhanced stability during knee motion.
Also known as: MS insert
A cruciate retaining polyethylene insert used in robotic-assisted total knee arthroplasty that preserves the posterior cruciate ligament.
Forgotten Joint Score (FJS)
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).
Time frame: Pre-operative, 6 weeks, 6 months, and 2 years post-operatively
Plan to share: Undecided
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Singapore General Hospital