Active — Not RecruitingNot Applicable

To Evaluate the Performance of the CORI™ KNEE TENSIONER as an Accessory to the CORI™ Surgical System.

United States50 participantsStarted 2022-02-10

Plain-language summary

To evaluate the performance of the CORI™ KNEE TENSIONER as an accessory to the CORI™ Surgical System.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subject agrees to consent to the study by signing the Independent Review Board (IRB) approved ICF.
✓. Subject is eighteen (18) years old or older.
✓. 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).
✓. Subject can read, understand, and communicate responses to Patient Reported Outcome Measures (PROMs).
✓. Subject is suitable for the CORI™ Surgical System.
✓. Subject requires a cemented TKA as a primary indication due to any of the following conditions:

✕. Contraindications or hypersensitivity to the use of the CORI™ Surgical System per the IFU.
✕. Participation in the treatment period of another clinical trial within thirty (30) days of the Pre-Operative Visit, or during the study.
✕. Women who are pregnant, nursing, or of child-bearing potential who are not utilizing birth control measures.
✕. Subjects who are non-English speaking.
✕. Any subject that meets the definition of a Vulnerable Subject per ISO 14155.
✕. Subjects who have participated previously in this clinical trial
✕. Subjects with a history of poor compliance with medical treatment.
✕. 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).

Quality of Life: EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) at 12 months

Timeframe: 12 months

NCT IDNCT04849884

SponsorSmith & Nephew, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-30

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subject agrees to consent to the study by signing the Independent Review Board (IRB) approved ICF.
✓. Subject is eighteen (18) years old or older.
✓. 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).
✓. Subject can read, understand, and communicate responses to Patient Reported Outcome Measures (PROMs).
✓. Subject is suitable for the CORI™ Surgical System.
✓. Subject requires a cemented TKA as a primary indication due to any of the following conditions:

✕. Contraindications or hypersensitivity to the use of the CORI™ Surgical System per the IFU.
✕. Participation in the treatment period of another clinical trial within thirty (30) days of the Pre-Operative Visit, or during the study.
✕. Women who are pregnant, nursing, or of child-bearing potential who are not utilizing birth control measures.
✕. Subjects who are non-English speaking.
✕. Any subject that meets the definition of a Vulnerable Subject per ISO 14155.
✕. Subjects who have participated previously in this clinical trial
✕. Subjects with a history of poor compliance with medical treatment.
✕. 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).