Patient Outcomes Following Kinematic and Functional Alignment in Robotic-Assisted Total Knee Arthroplasty With Randomized Insert Types

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSingapore General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Medial Stabilized Insert

    Device

    A medial stabilised polyethylene insert used in robotic-assisted total knee arthroplasty to provide enhanced stability during knee motion.

  • Cruciate Retaining Insert

    Device

    A cruciate retaining polyethylene insert used in robotic-assisted total knee arthroplasty that preserves the posterior cruciate ligament.

Treatment groups

240 Participants
are divided into 4 treatment groups
Group A: Kinematic Alignment + Medial Stabilized InsertExperimental treatment 1 intervention
Group B: Kinematic Alignment + Cruciate Retaining InsertExperimental treatment 1 intervention
Group C: Functional Alignment + Medial Stabilized InsertExperimental treatment 1 intervention
Group D: Functional Alignment + Cruciate Retaining InsertExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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