Taking peopleNo phase
Robotic Assisted Surgery In Total Knee Replacement
Key facts
- Who runs it
- Sahlgrenska University Hospital
- Where
- Sweden2 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 200 people, planned
- Started
- 1 Apr 2023
- Expected to end
- 1 Nov 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Triathlon
- Record updated
- 10 October 2023
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The goal of this clinical trial is to compare robotic arm assisted surgery with manual surgery in patients operated with knee replacement.
Read full original descriptionShow less
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.
The 2 groups in the trial
- MAKO TKATreatment being tested
Treatment: Triathlon
- ConventionalExisting treatment, for comparison
Treatment: Triathlon
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Robotic Assisted Surgery In Total Knee Replacement Versus Manual Total Knee Arthroplasty: A Randomized Controlled Trial
- Fit questions
- Built from NCT05842538, who can take part
- Record updated
- 10 October 2023