Kinematic Alignment in Total Knee Arthroplasty - a Double-blind Randomised Controlled Trial Between Robotic and Caliper-based Techniques
NCT ID: NCT06709703
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2025-02-28
2028-09-30
Brief Summary
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The goal of this study is to learn if robotic assisted surgery is better than traditional method for knee replacement done using kinematic alignment. The main questions the study tries to answer are:
1. Do the radiographs of kinematic knee replacement surgeries done with robotic assistance show better alignment than radiographs of kinematic knee replacements done with the traditional method?
2. Does robotic assisted kinematic knee replacement give better function to patients than traditional knee replacement done with kinematic alignment?
3. Does robotic assisted kinematic knee replacement decrease pain, improve knee movement and improve knee stability better than traditional knee replacement done with kinematic alignment?
4. Are there more complications with robotic assisted kinematic knee replacement in comparison to traditional kinematic knee replacement?
5. How long long does it take a surgeon to become good a performing a kinematic knee replacement using robotic assistance? Researchers will compare knee replacements done using a robotic to make the bone cuts, and compare it to the usual method using guides and manual instruments. All the knee replacements will be done using the kinematic alignment and with the same type of knee replacement prothesis.
Participants will:
* Have a knee replacement done with the kinematic alignment technique by an experienced surgeon, with or without robotic assistance during the surgery.
* Visit the clinic before surgery, six weeks after surgery, three months, six months, twelve months and twenty-four months after the surgery.
* Fill questionnaire, have their knee examined and have radiographs of their knee done at each visit.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Kinematic knee replacement with traditional instruments
Patients will undergo kinematic aligned knee replacement done using traditional instruments and cut guides
Kinematic aligned total knee replacement
Replacement of worn knee cartilage using a prosthesis. The alignment is determined according to the patient's anatomy and ligament balance.
Robotic-assisted kinematic knee replacement
Patients will undergo kinematic aligned knee replacement done using robotic assistance
Kinematic aligned total knee replacement
Replacement of worn knee cartilage using a prosthesis. The alignment is determined according to the patient's anatomy and ligament balance.
Interventions
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Kinematic aligned total knee replacement
Replacement of worn knee cartilage using a prosthesis. The alignment is determined according to the patient's anatomy and ligament balance.
Eligibility Criteria
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Inclusion Criteria
* Patient being consented for a primary total knee arthroplasty (TKA)
* The primary TKA is planned to be done with kinematic alignment
* All pre-operative alignments are included
Exclusion Criteria
* No available adequate pre-operative imaging
* Patient who does want to be randomized of the two groups
* At the discretion of the surgeon, if the patient's pathology or particular anatomy precludes the use of kinematic alignment technique, robotic surgery, or traditional instrument TKA.
18 Years
ALL
No
Sponsors
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Hopital Charles Lemoyne
OTHER
Université de Sherbrooke
OTHER
Responsible Party
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Samuel Larrivée
Orthopaedic Surgeon
Central Contacts
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References
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Zhang J, Ndou WS, Ng N, Gaston P, Simpson PM, Macpherson GJ, Patton JT, Clement ND. Robotic-arm assisted total knee arthroplasty is associated with improved accuracy and patient reported outcomes: a systematic review and meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2022 Aug;30(8):2677-2695. doi: 10.1007/s00167-021-06464-4. Epub 2021 Feb 6.
Agarwal N, To K, McDonnell S, Khan W. Clinical and Radiological Outcomes in Robotic-Assisted Total Knee Arthroplasty: A Systematic Review and Meta-Analysis. J Arthroplasty. 2020 Nov;35(11):3393-3409.e2. doi: 10.1016/j.arth.2020.03.005. Epub 2020 Mar 11.
Van Essen J, Stevens J, Dowsey MM, Choong PF, Babazadeh S. Kinematic alignment results in clinically similar outcomes to mechanical alignment: Systematic review and meta-analysis. Knee. 2023 Jan;40:24-41. doi: 10.1016/j.knee.2022.11.001. Epub 2022 Nov 17.
Dossett HG, Estrada NA, Swartz GJ, LeFevre GW, Kwasman BG. A randomised controlled trial of kinematically and mechanically aligned total knee replacements: two-year clinical results. Bone Joint J. 2014 Jul;96-B(7):907-13. doi: 10.1302/0301-620X.96B7.32812.
Turan K, Camurcu Y, Kezer M, Uysal Y, Kizilay YO, Ucpunar H, Temiz A. A comparison of robotic-assisted and manual techniques in restricted kinematically aligned total knee arthroplasty: coronal alignment improvement with no significant clinical differences. Knee Surg Sports Traumatol Arthrosc. 2023 Nov;31(11):4673-4679. doi: 10.1007/s00167-023-07426-8. Epub 2023 May 10.
Other Identifiers
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2025-958
Identifier Type: -
Identifier Source: org_study_id