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

NCT07533188 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-04-21

No results posted yet for this study

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

Interventions

DEVICE

Medial Stabilized Insert

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

DEVICE

Cruciate Retaining Insert

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

Sponsors & Collaborators

  • Singapore General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-14
Primary Completion
2027-10-14
Completion
2027-10-14

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07533188 on ClinicalTrials.gov