Manual Arthroplasty Versus VELYS Robotic-Assisted Solution Functional Alignment Arthroplasty for Knee Osteoarthritis

NCT07551856 | Not Yet Recruiting FDA Device

• 1 other identifier: 25/ORTH/02
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if the VELYS Robotic-Assisted Solution (VRAS) device helps to improve outcomes from total knee replacement, when compared to regular non-robotic-assisted total knee replacement in the treatment of osteoarthritis. It will also aim to review the longer-term safety and efficiency effects of using this device. The main questions it aims to answer are:

• Be randomised to receive a total knee replacement using either regular non-robotic-assisted methods, or with the use of the VRAS device.
• Be assessed pre-operatively at the clinic, and then at 6 weeks, 6 months, and 12 months following date of operation. At these appointments patients will answer questionnaires, receive an x-ray (pre-operatively, and at 6 months post-operatively), and a subgroup will be reviewed in the motion analysis laboratory (pre-operatively, and at 6 months post-operatively).
• Have their longer-term outcomes including any revision operations monitored out to 10 years through national registry data linkage (no actual follow-up for patients after 12 months).

Conditions

Knee Osteoarthritis; Osteoarthritis (Knee); Osteo Arthritis; Osteoarthritis (OA); Osteoarthritis; Osteoarthritis in the Knee; Osteo Arthritis of the Knee

Keywords

Knee; Osteoarthritis; Robotic; Alignment

Outcome Measures

Primary Outcomes (1)

• Change in Forgotten Joint Score

  Using validated Forgotten Joint Score questionnaire. Maximum score 100, minimum 0. Higher score equates to better outcome.

  Pre-surgery to be compared with 6 months post-surgery.

Secondary Outcomes (25)

• Change in Forgotten Joint Score

  Measured pre-operatively, and at 6 weeks, and 12 months.

• Absolute Forgotten Joint Score

  Measured at 6 weeks, 6 months, and 12 months.

• Oxford Knee Score

  Measured pre-operatively, at 6 weeks, 6 months, and 12 months.

• EQ-5D-5L

  Measured pre-operatively, at 6 weeks, 6 months, and 12 months.

• Satisfaction Score (Likert)

  Measured at 6 weeks, 6 months, and 12 months.

Study Arms (2)

VELYS Robotic-Assisted Total Knee Replacement

EXPERIMENTAL

Trial treatment, with an ATTUNE total knee replacement put in by a surgeon using robot-assistance for the bone cuts from the VELYS robot, allowing for functional alignment to be used.

Device: Robot-Assisted Functionally Aligned Total Knee Replacement

Manual Non-Robotic Total Knee Replacement

ACTIVE COMPARATOR

Current standard treatment, with an ATTUNE total knee replacement put in by a surgeon with no robot assistance, using manually-achievable alignment strategies.

Procedure: Manual Total Knee Arthroplasty

Interventions

Robot-Assisted Functionally Aligned Total Knee Replacement DEVICE

This device is a semi-active image-free arthroplasty robot that is under the full control of the surgeon at all times, but helps to make certain parts of the operation more accurate (bone cuts). The device will allow for use of so-called functional alignment. The implant put into the knee (ATTUNE total knee replacement) is the same for either of the techniques used (traditional method or VELYS robot). It has an excellent track record and is widely used in the UK and throughout the world.

VELYS Robotic-Assisted Total Knee Replacement

Manual Total Knee Arthroplasty PROCEDURE

This will be a manual total knee replacement carried out in standard fashion using ATTUNE implants with a good UK and worldwide track record. Alignment philosophies used will be manually achievable.

Manual Non-Robotic Total Knee Replacement

Eligibility Criteria

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

You may qualify if:

• Aged \>18 years
• Primary knee OA
• Requiring TKA
• Suitable for either raTKA or mTKA
• Capable to provide written informed consent
• Capable and willing to complete outcome measures throughout study period

You may not qualify if:

• Inflammatory arthritis
• Significant symptomatic hip, ankle, or contralateral knee OA
• Prior TKA or major injury or major surgery on the index knee
• Neuromuscular gait disorders
• BMI \>45 kg/m2
• Coronal plane deformity \>15° varus/valgus on pre-op HKA radiograph
• Fixed flexion deformity greater than 15°
• Bone loss likely to require non-standard implants (e.g. stems, augments)
• Severe deformity or ligament insufficiency likely to require constraint
• Inability to comply with the required follow-up assessments or complete PROMs
• Contraindications to any aspect of the surgical technique

Sponsors & Collaborators

• Golden Jubilee National Hospital: lead
• Johnson & Johnson: collaborator
• DePuy Orthopaedics: collaborator

Study Sites (1)

Golden Jubilee University National Hospital

Glasgow, Scotland, G81 4HX, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jon V Clarke, PhD, FRCS (Tr & Orth)

  Golden Jubilee University National Hospital

  STUDY CHAIR

• Nick D Clement, MD, PhD, FRCS (Tr & Orth)

  Edinburgh Orthopaedics, Royal Infirmary of Edinburgh

  STUDY CHAIR

• Andrew J Hall, PhD, MBChB, MRCS (Ed.)

  University of St Andrews

  STUDY CHAIR

• Joanne McGarry

  Golden Jubilee University National Hospital

  STUDY DIRECTOR

• Christopher Gee, MSc, FRCS (Tr & Orth), MFSTEd

  Golden Jubilee University National Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jon V Clarke, PhD, FRCS (Tr & Orth)

CONTACT

+44 (0)141 951 5564; jon.clarke@gjnh.scot.nhs.uk

Andrew J Hall, PhD, MBChB, MRCS (Ed.)

CONTACT

ajh52@st-andrews.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study is a randomised controlled trial with patient and outcome assessor blinding. It is not possible to blind surgeons given the nature of the interventions. Non-surgical clinical staff (e.g. ward nurses and allied health professionals) will be blinded. Femoral and tibial tracker pins will be placed within the surgical incision, avoiding the need for accessory incisions in raTKA cases or sham incisions to aid blinding in mTKA cases. Documentation will be redacted appropriately to prevent inadvertent unblinding of clinicians. PROMs will be completed independently by participants. Radiographic assessments and biomechanical analyses will be performed by assessors who are blinded to treatment allocation. All study data will be anonymised and the study arm concealed before the conduct of data analysis. No unblinding procedures are planned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 27, 2026
• Study Start (Estimated): May 8, 2026
• Primary Completion (Estimated): October 30, 2029
• Study Completion (Estimated): May 8, 2030
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning from the date of final end trial results publication
• Access Criteria: De-identified individual participant data underlying the reported results, together with the data dictionary and statistical code required to reproduce the primary analysis, will be considered for sharing with bona fide researchers on reasonable request. Requests must include a methodologically sound proposal and may require evidence of appropriate ethical and institutional approvals and completion of a data sharing agreement. Data will only be shared where this is consistent with participant consent, sponsor requirements, data protection legislation, and institutional information governance procedures. Requests should be directed to the study CI.

Locations

GB (1)