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

Not Applicable

Terminated

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

Interventions: Device: CORI
Device: Conventional

Registration Number: NCT04797897

Lead Sponsor: Smith & Nephew, Inc.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 4

Inclusion Criteria

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:
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
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.

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Post-operative Leg Alignment	6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Component Alignment: Femoral Antero-Posterior (A/P) Angle	6 weeks	Component alignment assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery. From the A/P radiograph, the femoral flexion angle in degrees was obtained using standard radiographic tools. Femoral flexion angle is defined as the angle formed between a line across the base of the femoral condyles and a line that is centered along the femoral canal.
Component Alignment: Total Antero-Posterior (A/P) Valgus Angle	6 weeks	Component alignment assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery. The total valgus angle is the sum of the femoral flexion angle and the tibial angle.
Five-level EuroQol Five-dimensional (EQ-5D-5L): Visal Analogue Scale (VAS) Score	Baseline, 6 weeks, 6 months, and 12 months	The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale (VAS). The VAS records the participant's self-rated health on a vertical visual analogue scale. The scale ranges from 0 to 100 where 0 indicates 'The worst health you can imagine' and 100 indicates 'The best health you can imagine'.
Component Alignment: Tibial Antero-Posterior (A/P) Angle	6 weeks	Component alignment assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery. From the A/P radiograph, the tibial angle denotes the angle formed on the medial side of the knee from intersecting lines parallel to the tibial base plate and a line drawn parallel to the tibial canal.
Component Alignment: Lateral View Femoral Flexion Angle	6 weeks	Component alignment assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery. The lateral view femoral flexion angle in degrees was obtained from the intersection of a line from the center of the femoral implant to the top of the femur with a line through the femoral canal. The angle is measured on the proximal side of the intersection.
Component Alignment: Lateral View Tibial Angle	6 weeks	Component alignment assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery. The lateral view tibial angle in degrees was obtained from the intersection of a line drawn parallel to the bottom of the tibial base insert and a line through the center of the tibial base and the tibial canal.
Radiographic Assessment	12 months	Radiographic assessment measured by number of participants with any radiographic finds on antero-posterior (A/P) and lateral (L) views (yes/no). Radiographic findings indicated the presence of radiolucent lines, osteolysis \& implant migration.
2011 Knee Society Score (KSS): Objective Knee Score	Baseline, 6 weeks, 6 months, and 12 months	The 2011 Knee Society Score consists of 4 separate sub-scales. The "Objective" Knee Score is seven items with a range of 0 to 100, with a higher score indicating a better outcome.
2011 Knee Society Score (KSS): Satisfaction Knee Score	Baseline, 6 weeks, 6 months, and 12 months	The 2011 Knee Society Score consists of 4 separate sub-scales. The Patient Satisfaction Score is five items with a range of 0 to 40, with a higher score indicating a better outcome.
2011 Knee Society Score (KSS): Expectation Score	Baseline, 6 weeks, 6 months, and 12 months	The 2011 Knee Society Score consists of 4 separate sub-scales. The Patient Expectation Score is three items with a range of 0 to 15, with a higher score indicating a better outcome. The Expectation score indicates the patient's opinion on the extent they expect the operation to improve their knee pain, and ability to perform activities of daily living and recreational activities.
2011 Knee Society Score (KSS): Functional Score	Baseline, 6 weeks, 6 months, and 12 months	The 2011 Knee Society Score consists of 4 separate sub-scales. The Functional Score is nineteen items with a range of 0 to 100, with a higher score indicating a better outcome. Functional Score is derived from assessments of walking and standing, standard activities, advanced activities, and discretionary activities.
Oxford Knee Score (OKS)	Baseline, 6 weeks, 6 months, and 12 months	The Oxford Knee Score (OKS) is a Patient Reported Outcome questionnaire that was developed to assess perceived function and pain answered on a Likert scale. Responses to each question ranges from 0-4 with a range of a possible overall score from 0-48. A score of 0 is the worst possible outcome while a score of 48 is the best possible outcome.
Forgotten Joint Score (FJS)	6 weeks, 6 months, and 12 months	The Forgotten Joint Score (FJS) comprises measures for the assessment of joint-specific patient reported outcomes. Participants are asked to rate their awareness of their knee arthroplasty in 12 questions with a five point Likert response format: "Never", "almost never", "seldom", "sometimes" and "mostly". The item scores are summed and linearly transformed in a 0 to 100 scale with a high value reflecting the ability of the subject to forget about the replaced knee joint during the activities of daily living (i.e., a higher score is a better outcome).
Five-level EuroQol Five-dimensional (EQ-5D-5L): Index Score	Baseline, 6 weeks, 6 months, and 12 months	The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale (VAS). The descriptive system (i.e., index score) is used to describe the participant's health state and consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems and extreme problems. The participant is asked to indicate their health state by marking the most appropriate statement in each of the five areas. The EQ-5D-5L Index Score was based on a scale of 0 to 1, with higher index values indicating better health and lower index values indicating worse health.

Trial Locations

Locations (3): Northern Hospital
🇦🇺
Epping, Australia
The Prince of Wales Hospital
🇭🇰
Sha Tin, Hong Kong
North Shore Hospital
🇳🇿
Auckland, New Zealand