Study to Evaluate Patient Outcomes and Safety and Effectiveness of Robotic Assisted Unicompartmen… (NCT06036212) | Clinical Trial Compass
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 range18 Years
SexALL
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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).
Exclusion criteria
✕. Contraindications or hypersensitivity to the use of the JII UK implant components (e.g., oxinium femoral, Tibial Baseplate, XPLE insert).
What they're measuring
1
Forgotten Joint Score 12 (FJS-12) at 12 Months Post Operative