Robotic Assisted Surgery In Total Knee Replacement
Recruiting · NCT05842538 · Interventional (participants receive a specific treatment) · Lead sponsor: Sahlgrenska University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Triathlon
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
2 locations listed.
- Sahlgrenska University hospital - Gothenburg, Sweden
- Örebro University Hospital, Department of Medical Sciences - Örebro, Sweden