New tensioner aims to improve knee replacement outcomes

NCT ID NCT06770153

Symptom relief Sponsor: Istituto Ortopedico Rizzoli Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a new tensioner device to standard surgical techniques for knee replacement. The goal is to see if the tensioner helps surgeons better balance the ligaments, leading to a more stable knee and less pain. Two hundred patients will be randomly assigned to receive either the tensioner-assisted or standard surgery, and their outcomes will be measured using stress X-rays and pain scores.

What this could mean

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

Active substance: tensioner device (TEMIS DePuy)
What this could lead to: If successful, this could lead to a more precise surgical technique for knee replacements, potentially improving joint stability and reducing pain after surgery.
What could go wrong: This is a relatively small, early-stage comparison study. The tensioner may not provide significant benefits over standard techniques, and results may not apply to all knee replacement patients.

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 200 people

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

Started

Oct 2024

Expected to finish

Oct 2026

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

50 to 85 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: * Male and female subjects candidates for primary cemented total knee prosthesis model Attune PS mobile plate DePuy. * Patients who possess all the psychophysical capabilities to be able to undergo the operation and all the check-ups with radiological tests included (e.g. all patients who are not willing to go to the institute for all the scheduled follow-up visits will be excluded) . * Patients who have signed the "informed consent" approved by the Ethics Committee. * Patients who are aged between 50-85. Exclusion Criteria: * Social conditions that prevent participation in the study in all its phases (homeless patients, with restrictions on personal freedom, etc.) * Patients suffering from deep venous insufficiency of the lower extremities or with a personal or family history of deep venous thrombosis or pulmonary embolism * Patients with a history of erysipelas in the lower extremities * Patients suffering from neurological or psycho-cognitive disorders * Patients suffering from post-traumatic arthrosis * Patients who have already undergone prosthetic surgery and/or arthrodesis at the level of a lower limb joint * Patients with axial knee deformities \>15° * Pregnant female patients * Patients with rheumatic diseases

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Conditions

The condition(s) this trial relates to.

Knee Injuries

As listed by the trial registrant

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

Knee injuries

How to take part

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

The places running it

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

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

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A doctor treating you

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New tensioner aims to improve knee replacement outcomes

What the study statuses mean