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Can GPS tech help surgeons align knee implants in obese patients?

NCT ID NCT03865524

Symptom relief Sponsor: Pedro-José Torrijos-Garrido Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 25, 2026 · Last updated Sep 25, 2026

Summary

Researchers are testing whether a GPS navigation system helps surgeons align total knee replacements more accurately than standard guides in obese patients. The trial enrolls 159 adults with knee osteoarthritis and a BMI of 30 or higher who are scheduled for a primary knee replacement. After surgery, the team measures X-rays to see how close each knee's mechanical axis comes to the target, aiming for a deviation of no more than 3 degrees.

What this could mean

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

Active substance
GPS navigation system for knee replacement surgery
What this could lead to
If navigation proves more accurate, surgeons could use it to place knee implants more precisely in obese patients, which may help the replacement last longer and feel better.
What could go wrong
This is a single-center study of 159 people, so results may not apply everywhere. Better X-ray alignment does not always translate into less pain or better function, and navigation adds operating time and cost.

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

159 people

The number who actually took part.

Started

Feb 2019

Finished

Nov 2024

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 years and older

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: * Men and women over 18 years old. * Written informed consent according to ICH / GCP and Spanish legislation, obtained before any study procedure. * Patient with a BMI equal to or greater than 30 Kg / m2 * Patients with clinical and radiological criteria of knee osteoarthritis. * Patients with indication for primary TKA according to medical criteria. Exclusion Criteria: * Pregnancy or lactation. * Inability to give informed consent in the absence of a legal representative. * Subjects that are participating in a study with medicines or other medical devices. * Those who show inability to follow the instructions or collaborate during the development of the study. * If in the opinion of the researcher there are findings in the physical examination, abnormalities in the results of the clinical analyzes or other medical, social or psychosocial factors that could have a negative influence * Having had a previous surgical procedure on or around the knee in the last 12 months (such as proximal tibial osteotomy, femoral osteotomy, open reduction and internal fixation for a fracture, patellectomy or patellar realignment). * Need a simultaneous bilateral TKA. * Have a varus angle or valgus ≥ 15 °. * Total revision knee arthroplasty.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder osteoarthritis, knee

As listed by the trial registrant

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

Arthropathy of knee Obesity Osteoarthritis, knee

Contacts and locations

Locations

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Santa Cristina

    Madrid, Madrid, 28009, Spain

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