New knee tensioner aims to improve replacement outcomes
NCT ID NCT04849884
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
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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
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77 people
The number who actually took part.
- Started
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Mar 2022
- Finished
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Jun 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Hospital for Special Surgery
New York, New York, 10021, United States
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Mount Carmel Research Institute
New Albany, Ohio, 43054, United States
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Tamarack Health
Ashland, Wisconsin, 54806, United States
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University of Pittsburgh, Magee
Pittsburgh, Pennsylvania, 15213, United States
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