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Recruiting NCT07533188

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

No phase Interventional Knee Osteoarthritis Degenerative Joint Disease of the Knee

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Medial Stabilized Insert, Cruciate Retaining Insert.
Who it may be relevant to
Registry conditions: Knee Osteoarthritis, Degenerative Joint Disease of the Knee. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective Randomized Controlled Trial Comparing Patient Outcomes Following Kinematic and Functional Alignment in Robotic-Assisted Total Knee Arthroplasty Using the VELYS System

Overview

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

  • 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.

Primary outcome measures

  • Forgotten Joint Score (FJS) [Time frame: Pre-operative, 6 weeks, 6 months, and 2 years post-operatively]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Singapore · 1 center
  • Singapore General Hospital — Singapore

Identifiers

NCT: NCT07533188 · SGH-VELYS-IMPLANT-RCT-2024 · 2024-4071

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗