Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Unicondylar Knee Arthroplasty (UKA) Procedures

NCT04797897 | Terminated Results FDA Device

• 1 other identifier: CORI.2019.06
• Study Type: interventional
• Target: 4
• Locations: 3 countries
• Sites: 3

Brief Summary

This is a prospective study to demonstrate the safety and effectiveness of CORI and to register CORI in China mainland.

Conditions

Non-inflammatory Degenerative Joint Disease; Osteoarthritis; Avascular Necrosis; Requires Correction of Functional Deformity; Fracture, Knee

Keywords

osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Post-operative Leg Alignment

  The number of participants with knees achieving post-operative leg alignment was taken by radiographic assessment at 6 weeks. Post-operative leg alignment was achieved when the deviation from the participant specific target did not exceed ±3 degrees.

  6 weeks

Secondary Outcomes (14)

• Component Alignment: Femoral Antero-Posterior (A/P) Angle

  6 weeks

• Component Alignment: Tibial Antero-Posterior (A/P) Angle

  6 weeks

• Component Alignment: Total Antero-Posterior (A/P) Valgus Angle

  6 weeks

• Component Alignment: Lateral View Femoral Flexion Angle

  6 weeks

• Component Alignment: Lateral View Tibial Angle

  6 weeks

Study Arms (2)

CORI UKA

EXPERIMENTAL

Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with CORI.

Device: CORI

Conventional UKA

ACTIVE COMPARATOR

Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with conventional approach with conventional manual instrumentation.

Device: Conventional

Interventions

CORI DEVICE

unicondylar knee arthroplasty (UKA) treated with CORI

CORI UKA

Conventional DEVICE

unicondylar knee arthroplasty (UKA) treated with conventional approach with conventional manual instrumentation

Conventional UKA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is a suitable candidate for a UKA procedure using CORI and a compatible S+N Knee implant system.
• Subject requires a cemented UKA as a primary indication that meets any of the following conditions:
• Non-inflammatory degenerative joint disease, including osteoarthritis
• Avascular necrosis
• Requires correction of functional deformity
• Requires treatment of fractures that were unmanageable using other techniques
• Subject is of legal age to consent and considered skeletally mature (≥ 18 years of age at the time of surgery).
• Subject agrees to consent to and to follow the study visit schedule (as defined in the study protocol and informed consent form), by signing the Ethics Committee (EC) or Institutional Review Board (IRB) approved informed consent form.
• Subject plans to be available through one (1) year postoperative follow-up.
• Applicable routine radiographic assessment if possible.

You may not qualify if:

• Subject receives a UKA on the index joint as a revision for a previously failed surgery, or need for complex implants, or any other implant than a standard UKA (e.g. stems, augments, or custom made devices).
• Subject has been diagnosed with post-traumatic arthritis
• Subject receives simultaneous bilateral UKA OR a unilateral UKA with contralateral TKA.
• Subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator:-Contralateral primary TKA or UKA, however, the subject can only have one knee enrolled in this study.
• Subject does not understand the language used in the Informed Consent Form.
• Subject does not meet the indication or is contraindicated for UKA according to specific S+N knee system's Instructions For Use (IFU).
• Subject has active infection or sepsis (treated or untreated).
• Subject is morbidly obese with a body mass index (BMI) greater than 40.
• Subject is pregnant or breast feeding at the time of surgery.
• Subject, in the opinion of the Investigator, has advanced osteoarthritis or joint disease at the time of surgery and was better suited for an alternate procedure.
• Subject currently enrolled in another orthopedic clinical trial study.
• Subject has a condition(s) that may interfere with the UKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease, or an active, local infection).
• Subject in the opinion of the Investigator has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, intellectual disability, drug or alcohol abuse.
• Subject, in the opinion of the Investigator, has a neuromuscular disorder that prohibited control of the index joint.
• Subject is a prisoner or meets the definition of a Vulnerable Subject per ISO 14155:2020 Section 3.55.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (3)

Northern Hospital

Epping, 3076, Australia

Location

The Prince of Wales Hospital

Shatin, Hong Kong

Location

North Shore Hospital

Auckland, 0620, New Zealand

Location

MeSH Terms

Conditions

Osteoarthritis; Osteonecrosis; Knee Fractures

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fractures, Bone; Wounds and Injuries; Knee Injuries; Leg Injuries

Limitations and Caveats

The study was terminated early by the sponsor due to low enrollment leading to a small number of participants analyzed. Meaning or reliable results could not be determined from the limited data available from 4 participants because of the early termination.

Results Point of Contact

• Title: Senior Manager Clinical Compliance
• Organization: Smith+Nephew, Inc

datasharing.gcs@smith-nephew.com

07811407089

Study Officials

• Patricia McCracken

  Smith & Nephew, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 15, 2021
• Study Start: February 12, 2022
• Primary Completion: September 29, 2023
• Study Completion: February 16, 2024
• Last Updated: March 25, 2025
• Results First Posted: March 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1); AU (1); HK (1)