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New knee tensioner aims to improve replacement outcomes

NCT ID NCT04849884

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Updated 2 times

Summary

This study is testing a device called the CORI™ KNEE TENSIONER, which helps surgeons balance the knee during total knee replacement surgery. Fifty adults who need a knee replacement will have the surgery using this device, and their recovery and quality of life will be tracked for one year. The goal is to see if the device makes the surgery more precise and improves patient outcomes.

What this could mean

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

Active substance
CORI™ KNEE TENSIONER device
What this could lead to
If successful, this device could help surgeons perform more precise knee replacements, potentially leading to better pain relief and mobility for patients.
What could go wrong
This is a small, early-stage study with only 50 participants, so results may not apply to everyone. The device is already on the market, but this study is checking if it works as intended.

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

77 people

The number who actually took part.

Started

Mar 2022

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: 1. Subject agrees to consent to the study by signing the Independent Review Board (IRB) approved ICF. 2. Subject is eighteen (18) years old or older. 3. Subject is willing and able to attend all study follow-up visits for up to one (1) year postoperatively (as defined in the study protocol and ICF). 4. Subject can read, understand, and communicate responses to Patient Reported Outcome Measures (PROMs). 5. Subject is suitable for the CORI™ Surgical System. 6. Subject requires a cemented TKA as a primary indication due to any of the following conditions: * Degenerative joint disease, including osteoarthritis * Rheumatoid arthritis. * Avascular necrosis. * Requires correction of functional deformity * Requires treatment of fractures that were unmanageable using other techniques. Exclusion Criteria: 1. Contraindications or hypersensitivity to the use of the CORI™ Surgical System per the IFU. 2. Participation in the treatment period of another clinical trial within thirty (30) days of the Pre-Operative Visit, or during the study. 3. Women who are pregnant, nursing, or of child-bearing potential who are not utilizing birth control measures. 4. Subjects who are non-English speaking. 5. Any subject that meets the definition of a Vulnerable Subject per ISO 14155. 6. Subjects who have participated previously in this clinical trial 7. Subjects with a history of poor compliance with medical treatment. 8. Subject needs a CORI™ Surgical System TKA on the index joint as a revision for a previously failed surgery, or need for complex implants, or any other implant than a standard TKA (e.g., stems, augments, or custom-made devices). 9. Subject has been diagnosed with post-traumatic arthritis 10. Subject needs a bilateral TKA. 11. Subject has active infection or sepsis (treated or untreated) 12. Subject is morbidly obese with a body mass index (BMI) greater than 40. 13. Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study. This includes: * Advanced osteoarthritis * Joint disease * Paget's or Charcot's disease * Vascular insufficiency * Muscular atrophy * Uncontrolled diabetes * Moderate to severe renal insufficiency * Neuromuscular disease * Mental illness or mental retardation * Drug or alcohol abuse

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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

  • Hospital for Special Surgery

    New York, New York, 10021, United States

  • Mount Carmel Research Institute

    New Albany, Ohio, 43054, United States

  • Tamarack Health

    Ashland, Wisconsin, 54806, United States

  • University of Pittsburgh, Magee

    Pittsburgh, Pennsylvania, 15213, United States

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