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Arthroplasty, Replacement, KneeNCT06036212

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)

A study testing Robotic System and Conventional in people with Arthroplasty, Replacement, Knee and Unicompartmental Knee Arthroplasty, run by Smith & Nephew, Inc. at 5 sites in United Kingdom.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Robotic System and Conventional
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
5 sitesUnited Kingdom
Study dates
21 Nov 2023to 15 Mar 2036
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.
  • 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.
  • Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United Kingdom5 sites

  • The Royal Orthopaedic Hospital NHS Foundation Trust

    Birmingham, West Midlands, B31 2AP

  • Colchester General Hospital

    Colchester, CO4 5JL

  • Central Middlesex Hospital

    London, NW10 7NS

  • Imperial College Healthcare NHS Trust, St Mary's Hospital

    London, W2 1NY

  • Norfolk and Norwich University Hospital NHS Foundation Trust

    Norwich, NR4 7UY

Other trials in United Kingdom

About this study

Official title: A Prospective, Single-blind, Multi-Centre, Randomised Controlled Study to Evaluate the Clinical and Patient Reported Outcomes Following Unicompartmental Knee Arthroplasty With a Robotic Assisted Technique

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.

Read the detailed description

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.

Being tested
Robotic System, Conventional
Keywords
Robotics assisted surgery, Computer assisted surgery, Unicompartmental knee arthroplasty, Unicompartmental knee replacement, Partial knee replacement, Partial knee arthroplasty, Journey II UK

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robotic SystemDevice

    Robotic assisted Unicompartmental Knee replacement (UKA)

  • ConventionalDevice

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

Study groups in NCT06036212
Study groupRoleWhat they receive
Journey II UK Partial Knee Implant with Robotic Assisted SurgeryExperimentalRobotically-assisted implant of the partial (unicompartmental) knee implant (Journey II UK)
Receives: Device: Robotic System
Journey II UK Partial Knee Implant with Conventional, Manual SurgerySham comparatorImplant of the partial (unicompartmental) knee implant (Journey II UK) with conventional, typical manual surgery
Receives: Device: Conventional

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months post operative

  2. 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.

    Measured: 10 years post operative

Secondary outcomes (9)

  1. 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.

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

  2. 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.

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

  3. 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.

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

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

    The descriptive system is used to describe the subject's health state \& consists of 5 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 subject is asked to indicate his/her health state by marking the most appropriate statement in each of the five areas. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. For instance, 'slight problems' (e.g. 'I have slight problems in walking about') is always coded as '2'. The digits for the 5 dimensions are combined in a 5-digit code. The EQ- 5D-5L index value is derived by using the vendor supplied calculator to convert each 5-digit EQ-5D-5L profile. A higher number is a better outcome.

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

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

    The EQ VAS records the subject's self-rated health on a vertical visual analogue scale. The endpoints on the scale are labelled "The best health you can imagine" and "The worst health you can imagine". Participants indicate a numerical value from 1-100 where 0 is the worst imaginable health state and 100 is the best imaginable health state. The VAS can be used as a quantitative measure of health outcome as judged by the individual respondents.

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

  6. Visual Analogue Scale (VAS) - Pain Score

    The Visual Analogue Score (VAS) - Pain Score is self-administered score assessing participant pain using Visual Analog Scale (VAS) assessments. Subjects will be asked to complete their pain levels on a scale of 0-100, 0 being no pain experienced and 100 meaning the worst pain possible.

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

  7. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), Activities of Daily Living (ADL) function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items).

    A Likert scale is used, and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.

    Measured: Pre-operative, 12 months, 2 years, 5 years, 10 years post operative

  8. Implant Survival at 2 Years and 5 Years

    Number of participants with implant survival at 2 years and 5 years with survival defined as lack of unicompartmental knee arthroplasty (UKA) revision.

    Measured: 2 years and 5 years post operative

  9. Forgotten Joint Score 12 (FJS-12)

    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.

    Measured: Baseline, 6 weeks, 6 months, 2 years, 5 years, 10 years post operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2023
  2. Study start21 Nov 2023
  3. Primary completion15 Mar 2027 (estimated)
  4. Study completion15 Mar 2036 (estimated)

Why it stopped: Terminated post suspension, no subjects enrolled

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06036212
Sponsor's protocol ID
2022.03 Robotics JII UK RCT
Status last verified
Oct 2025
First submitted
6 Sep 2023
Last updated
17 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Robotic System and Conventional in people with Arthroplasty, Replacement, Knee and Unicompartmental Knee Arthroplasty, run by Smith & Nephew, Inc. at 5 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Forgotten Joint Score 12 (FJS-12) at 12 Months Post Operative (time frame: 12 months post operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06036212.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.

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