Knee replacement robot showdown study pulled before start
NCT ID NCT06036212
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to see if using a robotic system for partial knee replacement leads to better outcomes than traditional surgery. It planned to follow patients for 10 years to measure how much they 'forgot' about their new knee and how long the implant lasted. However, the study was withdrawn before any participants were enrolled, so no results are available.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Started
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Nov 2023
- Expected to finish
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Mar 2036
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Central Middlesex Hospital
London, NW10 7NS, United Kingdom
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Colchester General Hospital
Colchester, CO4 5JL, United Kingdom
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Imperial College Healthcare NHS Trust, St Mary's Hospital
London, W2 1NY, United Kingdom
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Norfolk and Norwich University Hospital NHS Foundation Trust
Norwich, NR4 7UY, United Kingdom
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The Royal Orthopaedic Hospital NHS Foundation Trust
Birmingham, West Midlands, B31 2AP, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New knee implant under Real-World scrutiny: will it deliver better outcomes?
- Knee replacement pain relief: which catheter placement stays put?
- Smart patch could help knee replacement patients walk better faster