Study to Evaluate Patient Outcomes and Safety and Effectiveness of Robotic Assisted Unicompartmental Knee Replacements Versus Conventional Unicompartmental Knee for Subjects With Primary Arthritis of the Knee Joint Involving One (UKA) Compartment (Medial or Lateral)

Smith & Nephew, Inc.

Overview

The overall aim of this trial is to compare functional and patient-reported outcomes and to assess the safety and effectiveness and long-term performance of the Smith+Nephew Robotic Systems for Unicompartmental Knee Replacements to non-robotic, conventionally implanted Unicompartmental Knee Replacements.

There are two phases for this study: * Phase 1: The primary objective of this study is to compare Forgotten Joint Score (FJS) 12-month patient reported outcome scores, in patients undergoing robotic assisted Unicompartmental Knee Replacements as compared to those undergoing conventionally implanted Unicompartmental Knee Replacements * Phase 2: The primary objective of Phase 2 of this study is evaluate the revisions rates of the JII UK unicompartmental knee at 10 years Research participants / locations: 280 research participants will be recruited from up to 15 sites in the UK, US and Europe. There will be 140 participants undergoing robotic assisted Unicompartmental Knee Replacements and 140 participants undergoing non-robotic, conventionally implanted Unicompartmental Knee Replacements.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Arthroplasty, Replacement, Knee Unicompartmental Knee Arthroplasty

Interventions

Robotic SystemDEVICE

Robotic assisted Unicompartmental Knee replacement (UKA)

ConventionalDEVICE

Unicompartmental Knee Arthroplasty (UKA) with conventional approach and conventional manual instrumentation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. The subject or, legal guardian (in the case of difficulty reading and/or writing,) must provide written informed consent, including consent for any incidental findings to be reported to their General Practitioner (reference section 7.5). 2. Subjects eighteen (18) years and older and considered to be skeletally mature at the time of surgery. 3. Willing and able to make all required study visits (for both phases of the study, up to 10 years postoperatively). 4. Able to follow instructions and deemed capable of completing all the study questionnaires. 5. The subject has primary arthritis of the knee joint involving one (UKA) compartment (medial or lateral), and is suitable for JOURNEY II UK in the opinion of the surgeon. 6. The subject can, and is willing to have radiographic images taken to include non-standard of care imaging (for long leg radiographs at follow up). Exclusion Criteria: 1. Contraindications or hypersensitivity to the use of the JII UK implant components (e.g., oxinium femoral, Tibial Baseplate, XPLE insert). 2. The subject is contraindicated for the use of robotic-assisted knee arthroplasty. 3. Participation in the treatment period of another clinical trial within thirty (30) days of the preoperative visit, or during the study. 4. Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures. 5. Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55. 6. Subjects who have participated previously in this trial through UKR on other knee. 7. The subject is listed for a simultaneous bilateral knee arthroplasty 8. Subjects experiencing severe pain in both knees and consequently anticipating bilateral surgery within 12 months. 9. The subject requires a complex implant or any other implant, other than a standard UKR (e.g. stems, augments or custom-made devices) 10. Subject has an active infection or sepsis or has had previous intra-articular infections 11. Subjects with a history of poor compliance with medical treatment 12. The subject, in the opinion of the investigator, has a neuromuscular disorder (e.g. Charcot joint) that prohibits control of the index joint 13. Cases where bone stock is poor and would therefore make the procedure unjustifiable 14. Subjects with a BMI of 40 or higher 15. Those with incomplete/sufficient soft tissue around the joint. 16. Subjects with Conditions that tend to place increased loads on implants such as age, weight, and activity level, which are incompatible with a satisfactory long-term result. 17. Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

Locations (5)

The Royal Orthopaedic Hospital NHS Foundation Trust

Birmingham, West Midlands, United Kingdom

Colchester General Hospital

Colchester, United Kingdom

Central Middlesex Hospital

London, United Kingdom

Imperial College Healthcare NHS Trust, St Mary's Hospital

London, United Kingdom

Outcomes

Primary Outcomes

Forgotten Joint Score 12 (FJS-12) at 12 Months Post Operative

The Forgotten Joint Score 12 (FJS-12) is a self-administered score where subjects 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.

Time frame: 12 months post operative

Implant Survival at 10 years

Number of participants with implant survival at 10 years with survival defined as lack of unicompartmental knee arthroplasty (UKA) revision.

Time frame: 10 years post operative

Secondary Outcomes

Oxford Knee Score (OKS)

The Oxford Knee Score (OKS) is a self-administered score contains 12 equally weighted questions on activities of daily living. Responses to each question range 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.

Time frame: Pre-operative, 6 weeks, 6 months, 1 year, 2 years, 5 years, 10 years post operative

Oxford Arthroplasty Early Recovery Score (OARS)

The Oxford Arthroplasty Early Recovery Score (OARS) is a self-administered score regarding how the participant is feeling consisting of four domains: Pain, Sleep, Nausea and feeling unwell, and Mobility. The OARS questionnaire is scored 0-100 with zero being a poor recovery and 100 being positive and indicative of a good recovery.

Time frame: Day 1, day 2, day 3, day 7, day 14, 6 weeks post operative

Oxford Arthroplasty Early Change Score (OACS)

The Oxford Arthroplasty Early Change Score (OACS) is a self-administered score regarding how the participant feels after their surgery, compared to before, concentrating on areas such as ability, pain, overall feelings. The OACS questionnaire is scored from negative 50 to positive 50 with minus 50 being much worse than before surgery to 50 being much better than before surgery. Zero indicates no change from self-reported pre-operative health status.

Data from ClinicalTrials.gov

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