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

NCT07533188 | Recruiting

• 2 other identifiers: SGH-VELYS-IMPLANT-RCT-20242024-4071
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Degenerative Joint Disease of the Knee

Keywords

Robotic-Assisted Total Knee Arthroplasty; VELYS System; Kinematic Alignment; functional Alignment; Medial Stabilized Insert; Cruciate Retaining Insert; Patient-Reported Outcomes; Total Knee Replacement

Outcome Measures

Primary Outcomes (1)

• Forgotten Joint Score (FJS)

  The Forgotten Joint Score (FJS) is used to assess patient-reported outcomes following total knee arthroplasty.

  Pre-Operative, 6 Weeks, 6 Months, 2 Years, and 10 Years Post-Operatively

Study Arms (4)

Kinematic Alignment + Medial Stabilized Insert

EXPERIMENTAL

Patients undergoing kinematic alignment with medial stabilised insert in robotic-assisted total knee arthroplasty.

Device: Medial Stabilized Insert

Kinematic Alignment + Cruciate Retaining Insert

EXPERIMENTAL

Patients undergoing kinematic alignment with cruciate retaining insert in robotic-assisted total knee arthroplasty

Device: Cruciate Retaining Insert

Functional Alignment + Medial Stabilized Insert

EXPERIMENTAL

Patients undergoing functional alignment with medial stabilised insert in robotic-assisted total knee arthroplasty.

Device: Medial Stabilized Insert

Functional Alignment + Cruciate Retaining Insert

EXPERIMENTAL

Patients undergoing functional alignment with cruciate retaining insert in robotic-assisted total knee arthroplasty

Device: Cruciate Retaining Insert

Interventions

Medial Stabilized Insert DEVICE

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

Also known as: MS insert

Functional Alignment + Medial Stabilized Insert; Kinematic Alignment + Medial Stabilized Insert

Cruciate Retaining Insert DEVICE

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

Functional Alignment + Cruciate Retaining Insert; Kinematic Alignment + Cruciate Retaining Insert

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• Patients undergoing revision knee arthroplasty Presence of active infection Inability to comply with follow-up assessments Severe comorbidities that may affect surgical outcomes or participation in the study

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A/Prof Dr Lincoln Liow

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 16, 2026
• Study Start: October 14, 2025
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): December 30, 2030
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

SG (1)