WithdrawnNot Applicable

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)

Stopped: Terminated post suspension, no subjects enrolled

United Kingdom0Started 2023-11-21

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 12 months post operative

Implant Survival at 10 years

Timeframe: 10 years post operative

Trial details

NCT IDNCT06036212

SponsorSmith & Nephew, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03-15

View on ClinicalTrials.gov More Arthroplasty, Replacement, Knee trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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).

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)

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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)

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria