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

Sponsor
Université de Sherbrooke
Study ID
NCT06709703
Status
Not Yet Recruiting

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Conditions

  • Arthritis
  • Arthritis (Knee)
  • Gonarthrosis; Primary
  • OA
  • OA Knee
  • OA Knee Pain
  • Osteoarthritis
  • Osteoarthritis Knee Pain
  • Osteoarthritis of Knee

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Kinematic aligned total knee replacement — PROCEDURE
    Replacement of worn knee cartilage using a prosthesis. The alignment is determined according to the patient's anatomy and ligament balance.

Study Details

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.

Key Dates

First listed
Nov 29, 2024
Start date
Feb 28, 2025
Status verified
Nov 2024
Primary completion
Jul 31, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Kinematic knee replacement with traditional instruments
    Patients will undergo kinematic aligned knee replacement done using traditional instruments and cut guides
  • Experimental: Robotic-assisted kinematic knee replacement
    Patients will undergo kinematic aligned knee replacement done using robotic assistance

Primary Outcome Measure

Radiographic alignment of the knee [ Time Frame: Pre-operative alignement and 6 months post-operative alignement. ]

Central Contacts

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