Clinical trial Recruiting at 2 sites Interventional Ages 18 to 80

Comparing robotic and manual surgery for knee replacement

Official title: Robotic Assisted Surgery In Total Knee Replacement Versus Manual Total Knee Arthroplasty: A Randomized Controlled Trial

Run by Sahlgrenska University Hospital · NCT05842538 · Data updated 2026-11-12

This study is testing whether robotic surgery is better than traditional surgery for knee replacement in people with knee osteoarthritis.

Quick facts

Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment200 (estimated)
SponsorSahlgrenska University Hospital
Academic / other
Locations2 sites (Gothenburg and 1 other locations)
StatusRecruiting
StartedApril 1, 2023
Main results expectedNovember 1, 2025
Study endsNovember 1, 2027
Registry record updatedOctober 10, 2023
Trial IDNCT05842538 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 to 80 who are listed for elective primary total knee replacement due to end-stage osteoarthritis.

Probably not a fit

Patients with significant knee deformities, those requiring patella resurfacing, or individuals unable to comply with study protocols may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of robotic arm-assisted surgery compared to traditional manual surgery in patients undergoing total knee replacement due to knee osteoarthritis. Participants will be randomly assigned to either the robotic-assisted group or the manual surgery group, with their joint awareness assessed using the Forgotten Joint Score over a follow-up period of 24 months. Secondary objectives include measuring pain levels, quality of life, knee function, and revision rates. The study will involve a total of 200 participants across multiple centers.

Why it matters

Potential benefit: If successful, this study could lead to improved outcomes and enhanced joint awareness for patients undergoing knee replacement surgery.

How similar studies have gone: Other studies have shown promising results with robotic-assisted surgeries, indicating potential benefits over traditional methods.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Sahlgrenska University hospital
    Gothenburg, Sweden
    Recruiting
  • Örebro University Hospital, Department of Medical Sciences
    Örebro, Sweden
    Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.