NCT05842538 Robotic Assisted Surgery In Total Knee Replacement
| NCT ID | NCT05842538 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sahlgrenska University Hospital |
| Condition | Knee Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-04-01 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2023-04-01 with a primary completion date of 2025-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to compare robotic arm assisted surgery with manual surgery in patients operated with knee replacement. The main aim of the study is to compare changes in joint awareness (measured by the Forgotten Joint Score. Participants who are listed for knee arthroplasty are randomised to either robotic arm assisted surgery or manual surgery.
Eligibility Criteria
Inclusion Criteria: * Listed for elective primary TKR for end stage osteoarthritis * Suitable candidate for a cruciate retaining TKR (Triathlon prosthesis) * Male or Female, aged 18 years or above (18-80 at the time of listing for surgery). * Able to understand and provide written consent. Exclusion Criteria: * Varus deformity of \> 20 degrees observed by consultant on examination * Patient is unable to comply with the study protocol (incl. refusal for CT scan) * Female participant who is pregnant, lactating or planning pregnancy during the course of the study. * Requires patella resurfacing * Inability to understand the patient information for the study, provide written informed consent or answer study questionnaires for cognitive or language reasons * Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Frequently Asked Questions
Who can join the NCT05842538 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05842538 currently recruiting?
Yes, NCT05842538 is actively recruiting participants. Visit ClinicalTrials.gov or contact Sahlgrenska University Hospital to inquire about joining.
Where is the NCT05842538 trial being conducted?
This trial is being conducted at Gothenburg, Sweden, Örebro, Sweden.
Who is sponsoring the NCT05842538 clinical trial?
NCT05842538 is sponsored by Sahlgrenska University Hospital. The trial plans to enroll 200 participants.