Clinical trial NCT04797897: Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Unicondylar Knee Arthroplasty (UKA) Procedures
Official title: A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Unicondylar Knee Arthroplasty (UKA) Procedures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Non-inflammatory Degenerative Joint Disease
Osteoarthritis
Avascular Necrosis
Requires Correction of Functional Deformity
Fracture, Knee
Keywords: osteoarthritis
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-15
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: This is a prospective, multi-center, randomized study to demonstrate the safety and effectiveness of CORI. In addition, the study will support regulatory approval by the National Medical Products Administration (NMPA) in China.

The study will have two arms, the investigational group will be total knee arthroplasty (TKA) using CORI, the comparison group will be conventional approach with conventional manual instrumentation.

Eligibility criteria: Inclusion Criteria:

1. Subject is a suitable candidate for a UKA procedure using CORI and a compatible S+N Knee implant system.
2. Subject requires a cemented UKA as a primary indication that meets any of the following conditions:

   1. Non-inflammatory degenerative joint disease, including osteoarthritis
   2. Avascular necrosis
   3. Requires correction of functional deformity
   4. Requires treatment of fractures that were unmanageable using other techniques
3. Subject is of legal age to consent and considered skeletally mature (≥ 18 years of age at the time of surgery).
4. 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.
5. Subject plans to be available through one (1) year postoperative follow-up.
6. Applicable routine radiographic assessment if possible.

Exclusion Criteria:

1. 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).
2. Subject has been diagnosed with post-traumatic arthritis
3. Subject receives simultaneous bilateral UKA OR a unilateral UKA with contralateral TKA.
4. 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.
5. Subject does not understand the language used in the Informed Consent Form.
6. Subject does not meet the indication or is contraindicated for UKA according to specific S+N knee system's Instructions For Use (IFU).
7. Subject has active infection or sepsis (treated or untreated).
8. Subject is morbidly obese with a body mass index (BMI) greater than 40.
9. Subject is pregnant or breast feeding at the time of surgery.
10. 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.
11. Subject currently enrolled in another orthopedic clinical trial study.
12. 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).
13. 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.
14. Subject, in the opinion of the Investigator, has a neuromuscular disorder that prohibited control of the index joint.
15. Subject is a prisoner or meets the definition of a Vulnerable Subject per ISO 14155:2020 Section 3.55.

Primary outcomes:
measure: Post-operative Leg Alignment
timeFrame: 6 weeks
Secondary outcomes:
measure: Component Alignment: Femoral Antero-Posterior (A/P) Angle
timeFrame: 6 weeks
measure: Component Alignment: Tibial Antero-Posterior (A/P) Angle
timeFrame: 6 weeks
measure: Component Alignment: Total Antero-Posterior (A/P) Valgus Angle
timeFrame: 6 weeks
measure: Component Alignment: Lateral View Femoral Flexion Angle
timeFrame: 6 weeks
measure: Component Alignment: Lateral View Tibial Angle
timeFrame: 6 weeks
measure: Radiographic Assessment
timeFrame: 12 months
measure: 2011 Knee Society Score (KSS): Objective Knee Score
timeFrame: Baseline, 6 weeks, 6 months, and 12 months
measure: 2011 Knee Society Score (KSS): Satisfaction Knee Score
timeFrame: Baseline, 6 weeks, 6 months, and 12 months
measure: 2011 Knee Society Score (KSS): Expectation Score
timeFrame: Baseline, 6 weeks, 6 months, and 12 months
measure: 2011 Knee Society Score (KSS): Functional Score
timeFrame: Baseline, 6 weeks, 6 months, and 12 months
measure: Oxford Knee Score (OKS)
timeFrame: Baseline, 6 weeks, 6 months, and 12 months
measure: Forgotten Joint Score (FJS)
timeFrame: 6 weeks, 6 months, and 12 months
measure: Five-level EuroQol Five-dimensional (EQ-5D-5L): Index Score
timeFrame: Baseline, 6 weeks, 6 months, and 12 months
measure: Five-level EuroQol Five-dimensional (EQ-5D-5L): Visal Analogue Scale (VAS) Score
timeFrame: Baseline, 6 weeks, 6 months, and 12 months
Other outcomes:
Locations:
city: Epping
country: Australia
facility: Northern Hospital
city: Sha Tin
country: Hong Kong
facility: The Prince of Wales Hospital
city: Auckland
country: New Zealand
facility: North Shore Hospital
Study officials:
affiliation: Smith & Nephew, Inc.
name: Patricia McCracken
role: STUDY_DIRECTOR
References: