Robotic Assisted Surgery In Total Knee Replacement
1 other identifier
interventional
200
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable knee-osteoarthritis
Started Apr 2023
Longer than P75 for not_applicable knee-osteoarthritis
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2022
CompletedStudy Start
First participant enrolled
April 1, 2023
CompletedFirst Posted
Study publicly available on registry
May 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
ExpectedOctober 10, 2023
October 1, 2023
2.6 years
October 3, 2022
October 9, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Forgotten Joint Score
Patient-reported outcome
1 year
Secondary Outcomes (4)
Knee pain
2 years
EQ-5D
3, 12, 24 months
Oxford Knee Score
3, 12, 24 months
Knee Society Score
3, 12, 24 months
Study Arms (2)
MAKO TKA
EXPERIMENTALConventional
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sahlgrenska University Hospitallead
- Stryker Nordiccollaborator
Study Sites (2)
Sahlgrenska University hospital
Gothenburg, Sweden
Örebro University Hospital, Department of Medical Sciences
Örebro, 705 85, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 3, 2022
First Posted
May 6, 2023
Study Start
April 1, 2023
Primary Completion
November 1, 2025
Study Completion (Estimated)
November 1, 2027
Last Updated
October 10, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share