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Custom 3D-Printed tools aim to sharpen knee surgery precision

NCT ID NCT07212777

Disease control Sponsor: University of Malaga Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 23, 2026 · Updated 3 times

Summary

This study compares two ways to perform a knee realignment surgery (high tibial osteotomy) in 50 adults with knee arthritis and bow-legged deformity. One group gets the standard surgery using X-ray guidance; the other uses a custom 3D-printed guide to make the bone cut. Researchers will check if the 3D guide leads to a more accurate cut and better leg alignment, and track recovery for up to a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
patient-specific 3D-printed surgical guide
What this could lead to
If successful, this could make knee osteotomy more precise, potentially leading to better alignment and faster recovery for patients with knee arthritis.
What could go wrong
This is a small, early-phase trial with only 50 participants, so results may not apply to everyone. The new guide might not improve outcomes enough to justify the extra cost and planning.

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

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Oct 2028

An estimate. End dates often move.

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 70 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: * Informed consent: able to sign informed consent * Clinical: predominantly medial pain/limitation refractory ≥3-6 months * Mobility: flexion ≥90º and flexion contracture ≤10º Stability: varus/valgus and pivot-shift ≤ grade 1. * Radiology: * Medial gonarthrosis Ahlbäck I-III with preserved lateral compartment. * Patellofemoral Iwano 0-2 without disabling patellofemoral pain. * Varus alignment: HKA 4-10°. * Predominantly tibial deformity (decreased MPTA; LDFA close to normal) according to planning. * Anatomy/technical feasibility: proximal tibial morphology suitable for medial opening osteotomy and PSI guide placement. Exclusion criteria: * Comorbidity/clinical situations: * Inflammatory arthritis (e.g., RA, spondyloarthropathies), unresolved previous joint infection or osteomyelitis. * Severe peripheral vasculopathy (ABI \<0.7), advanced peripheral neuropathy or Charcot foot. * Poorly controlled diabetes (HbA1c \>8.5%), advanced renal/hepatic failure (eGFR \<30 ml/min/1.73 m²; Child-Pugh B/C). * Smoking \>20 cigarettes/day without commitment to cessation; active IV drug use or uncontrolled alcoholism. * BMI \>35 kg/m². * Disorder affecting gait (e.g., neurological disease). * Inability to walk at a speed of at least 0.8m/s * Anatomy/radiology * Multiplanar deformities not correctable with isolated medial opening tibial valgus osteotomy (e.g., dominant femoral deformity). * Severe medial subchondral bone defect or extensive necrosis. * Sequelae of proximal tibia fracture or previous ipsilateral HTO that prevent correction or guide use. * Treatments/medication and logistics * Anticoagulation/antiplatelet therapy that cannot be suspended or bridged. * Systemic corticosteroids \>10 mg/day or high-risk immunosuppressants without possibility of adjustment. * Intra-articular infiltration (HA/CS/PRP) within the previous 60 days (respect defined wash-out). * Pregnancy. * Participation in another interfering trial. * Inability to undergo CT (e.g., uncontrollable claustrophobia). * Inability to complete ≥12 months of follow-up.

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Conditions

The condition(s) this trial relates to.

arthritic joint disease osteoarthritis, knee

As listed by the trial registrant

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

Arthritis knee Varus knee

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Universitario Virgen de la Victoria de Málaga

    RECRUITING

    Málaga, Málaga, 29010, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.