Kinematic Alignment in Total Knee Arthroplasty - a Double-blind Randomised Controlled Trial Between Robotic and Caliper-based Techniques

Université de Sherbrooke

Status: Not yet enrolling

Conditions: Osteoarthritis; OA Knee; OA Knee Pain; Arthritis; Osteoarthritis of Knee; OA; Osteoarthritis Knee Pain; Arthritis (Knee); Gonarthrosis; Primary

Treatments: Procedure: Kinematic aligned total knee replacement

Study type: Interventional

Funder types: Other

Identifiers

NCT06709703

2025-958

Details and patient eligibility

About

Knee replacement surgery is a surgery designed to treat severe arthritis of the knee. However, as many as 20% of patients are not satisfied with the results of their surgery. To place the knee replacement in correct position, the kinematic alignment method, which tries to reproduce the patient normal anatomy, has shown promise in improving the satisfaction after knee replacement surgery. It is not known if using a robotic arm to assist in surgery is better than the traditional method when trying to recreate kinematic alignment.

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient aged 18 or above
• 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

• Revision TKA (including revision of unicompartimental knee arthroplasty into total knee arthroplasty with primary components). TKA being done in the setting of previous femur or tibia fracture or osteotomy are however included.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Kinematic knee replacement with traditional instruments

Active Comparator group

Description:

Patients will undergo kinematic aligned knee replacement done using traditional instruments and cut guides

Treatment:

Procedure: Kinematic aligned total knee replacement

Robotic-assisted kinematic knee replacement

Experimental group

Description:

Patients will undergo kinematic aligned knee replacement done using robotic assistance

Treatment:

Procedure: Kinematic aligned total knee replacement