Status:
ACTIVE_NOT_RECRUITING
To Evaluate the Performance of the CORI™ KNEE TENSIONER as an Accessory to the CORI™ Surgical System.
Lead Sponsor:
Smith & Nephew, Inc.
Conditions:
Arthroplasty
Replacement
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To evaluate the performance of the CORI™ KNEE TENSIONER as an accessory to the CORI™ Surgical System.
Detailed Description
This is a post-market, prospective, multicenter, open-label study evaluating the performance of the CORI™ KNEE TENSIONER as an accessory to the CORI™ Surgical System at approximately 4 centers across ...
Eligibility Criteria
Inclusion
- 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:
- 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
- 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).
- Subject has been diagnosed with post-traumatic arthritis
- Subject needs a bilateral TKA.
- Subject has active infection or sepsis (treated or untreated)
- Subject is morbidly obese with a body mass index (BMI) greater than 40.
- 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
Key Trial Info
Start Date :
February 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04849884
Start Date
February 10 2022
End Date
April 30 2026
Last Update
August 17 2025
Active Locations (4)
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1
Hospital for Special Surgery
New York, New York, United States, 10021
2
OrthoNeuro
New Albany, Ohio, United States, 43054
3
University of Pittsburgh, Magee
Pittsburgh, Pennsylvania, United States, 15213
4
Memorial Medical Center
Ashland, Wisconsin, United States, 54806