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Custom knee surgery aims for better alignment in osteoarthritis patients

NCT ID NCT04666571

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a personalized surgical guide (TOKA) helps surgeons correct knee alignment more accurately than standard tools. 56 adults with medial knee osteoarthritis took part. The goal was to see if the custom approach leads to better bone alignment after surgery, which may improve long-term outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

56 people

The number who actually took part.

Started

Sep 2021

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients undergoing High Tibial Osteotomy * Male or Female, aged 18 to 65 years * Primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD) * Predominately diagnosed with unicompartmental medial osteoarthritis of the knee with the normal clinically acceptable level of other compartmental involvement * Varus deformity \<20 ° * BMI ≤ 35. An exemption to this may be made if the participant (in the investigators opinion) is suitable for surgery. * Participant is willing and able to give informed consent for participation in the study. * Able (in the Investigators opinion) and willing to comply with all study requirements. * Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study. Exclusion Criteria: * Female participants who are pregnant, lactating or planning pregnancy during the course of the study. * Prisoners * Participants with a known deep tissue sensitivity to device materials * Participants with an active or suspected latent infection in or about the affected knee joint * Participants who have received any orthopaedic surgical intervention to the lower extremities (excluding investigative surgery) within the past 12 months, or is expected to require any orthopaedic surgical intervention to the lower extremities, other than the HTO to be enrolled in this study, within the next 12 months (including intra-articular procedures). * Participants who require bilateral HTO with surgery planned on their second knee within 6 months of their first operation (bilateral HTO patients are otherwise included). * Participants who require bilateral HTO who have had a previous unsuccessful contralateral partial replacement or HTO * Chronic heart failure (NYHA Stage ≥ 2) * Neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device * Systemic disease diagnosis (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration. * Participant is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days). * Participant is a smoker. * Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Cardiff and Vale University Health Board

    Cardiff, Wales, CF14 4XW, United Kingdom

  • Great Western Hospital

    Swindon, Wiltshire, SN3 6BB, United Kingdom

  • Oxford University Hospitals NHS Trust

    Oxford, Oxfordshire, OX3 7HE, United Kingdom

  • Royal Devon and Exeter NHS Foundation Trust

    Exeter, United Kingdom

  • Royal Orthopaedic Hospital

    Birmingham, West Midlands, B31 2AP, United Kingdom

  • Royal United Hospitals NHS Trust

    Bath, Avon, BA1 3NG, United Kingdom

  • Walsall Manor Hospital

    Walsall, West Midlands, WS2 9PS, United Kingdom

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