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)

NCT06036212 | Withdrawn FDA Device

• 1 other identifier: 2022.03 Robotics JII UK RCT
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Arthroplasty, Replacement, Knee; Unicompartmental Knee Arthroplasty

Keywords

Robotics assisted surgery; Computer assisted surgery; Unicompartmental knee arthroplasty; Unicompartmental knee replacement; Partial knee replacement; Partial knee arthroplasty; Journey II UK

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  10 years post operative

Secondary Outcomes (9)

• Oxford Knee Score (OKS)

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

• Oxford Arthroplasty Early Recovery Score (OARS)

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

• Oxford Arthroplasty Early Change Score (OACS)

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

• EuroQol Five-Dimensional Five-Level (EQ-5D-5L) - Descriptive System

  Pre-operative, 6 weeks, 6 months, 12 months, 2 years, 5 years, 10 years post operative

• EuroQol Five-Dimensional Five-Level (EQ-5D-5L) - Visual Analogue Scale (VAS)

  Pre-operative, 6 weeks, 6 months, 12 months, 2 years, 5 years, 10 years post operative

Study Arms (2)

Journey II UK Partial Knee Implant with Robotic Assisted Surgery

EXPERIMENTAL

Robotically-assisted implant of the partial (unicompartmental) knee implant (Journey II UK)

Device: Robotic System

Journey II UK Partial Knee Implant with Conventional, Manual Surgery

SHAM COMPARATOR

Implant of the partial (unicompartmental) knee implant (Journey II UK) with conventional, typical manual surgery

Device: Conventional

Interventions

Robotic System DEVICE

Robotic assisted Unicompartmental Knee replacement (UKA)

Journey II UK Partial Knee Implant with Robotic Assisted Surgery

Conventional DEVICE

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

Journey II UK Partial Knee Implant with Conventional, Manual Surgery

Eligibility Criteria

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

You may qualify if:

• 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).
• Subjects eighteen (18) years and older and considered to be skeletally mature at the time of surgery.
• Willing and able to make all required study visits (for both phases of the study, up to 10 years postoperatively).
• Able to follow instructions and deemed capable of completing all the study questionnaires.
• 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.
• 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).

You may not qualify if:

• Contraindications or hypersensitivity to the use of the JII UK implant components (e.g., oxinium femoral, Tibial Baseplate, XPLE insert).
• The subject is contraindicated for the use of robotic-assisted knee arthroplasty.
• Participation in the treatment period of another clinical trial within thirty (30) days of the preoperative visit, or during the study.
• Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures.
• Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55.
• Subjects who have participated previously in this trial through UKR on other knee.
• The subject is listed for a simultaneous bilateral knee arthroplasty
• Subjects experiencing severe pain in both knees and consequently anticipating bilateral surgery within 12 months.
• The subject requires a complex implant or any other implant, other than a standard UKR (e.g. stems, augments or custom-made devices)
• Subject has an active infection or sepsis or has had previous intra-articular infections
• Subjects with a history of poor compliance with medical treatment
• The subject, in the opinion of the investigator, has a neuromuscular disorder (e.g. Charcot joint) that prohibits control of the index joint
• Cases where bone stock is poor and would therefore make the procedure unjustifiable
• Subjects with a BMI of 40 or higher
• Those with incomplete/sufficient soft tissue around the joint.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (5)

The Royal Orthopaedic Hospital NHS Foundation Trust

Birmingham, West Midlands, B31 2AP, United Kingdom

Location

Colchester General Hospital

Colchester, CO4 5JL, United Kingdom

Location

Central Middlesex Hospital

London, NW10 7NS, United Kingdom

Location

Imperial College Healthcare NHS Trust, St Mary's Hospital

London, W2 1NY, United Kingdom

Location

Norfolk and Norwich University Hospital NHS Foundation Trust

Norwich, NR4 7UY, United Kingdom

Location

Study Officials

• Patricia McCracken

  Smith & Nephew, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blinded to study participant. The study participants will not be aware of the treatment received. For those not being put under general anesthetic during the procedure, a screen will be put up between the subjects face and the ongoing procedure and associated platforms/instrumentation so that they are unable to see any of the procedure and are unable to guess whether they are having robotics assisted surgery or conventional surgery. Extra incisions (maximum of 4 based on approach that the operating surgeon uses) are required to conduct robotic assisted surgery, those subjects receiving conventional surgery will receive sham incisions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 13, 2023
• Study Start: November 21, 2023
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): March 15, 2036
• Last Updated: November 17, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5)