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NCT Number: NCT06709703

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

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.

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Key information

Conditions

Arthritis Arthritis (Knee) Gonarthrosis; Primary Joint Diseases Musculoskeletal Diseases OA OA Knee OA Knee Pain Osteoarthritis Osteoarthritis Knee Pain Osteoarthritis of Knee Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Radiographic alignment of the knee

    Time frame: Pre-operative alignement and 6 months post-operative alignement.

    Long leg anteroposterior views of both legs and lateral knee radiographs will be used to measure knee alignment and position of the knee replacement hardware. The angles measured and analyzed will be:

    • The hip-knee-ankle (HKA) angle
    • Medial proximal tibia mechanical angle (MPTAm)
    • Lateral distal femur mechanical angle (LDTAm)
    • Distal femur flexion angle (DFFA)
    • Posterior tibial slope (PTS) Radiographic measurements will be made by a trained observer and a fellowship-train arthroplasty surgeon.

  2. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: Pre-operative, 6 weeks, 6 months, 12 months, 24 months post-operative

    Patient questionnaire (42 questions) evaluating knee pain, symptoms, function, recreational activities and knee-related quality of life. The questionnaire is score over 100 points, with a higher score meaning better knee function.

  3. Forgotten joint score

    Time frame: Pre-operative, 6 weeks, 6 months, 12 months and 24 months post-op

    A 12-questions form asking patients if they forget about their joint during activities of daily living.

  4. Joint perception question

    Time frame: Pre-operative, 6 weeks, 6 months, 12 months and 24 months post-operative

    A single item question asking participants how they perceive their operated knee, from "like a native or natural joint" to "like a nonfunctional joint".

Secondary outcomes

  1. Pain visual analog scale

    Time frame: Pre-op, 6 weeks, 6, 12, 24 months

    Pain rated on a 10 cm visual analog scale from "no pain" to "worst pain imaginable"

  2. Subjective Assessment Numeric Evaluation Scale (SANE)

    Time frame: Pre-op, 6 weeks, 6, 12, 24 months

    Single question evaluation scale asking the patient to rate their knee function from 0 (no function) to 100 (completely normal function)

  3. Knee range of motion

    Time frame: Pre, 6 weeks, 6 and 12 months post-op

    Maximum passive flexion and extension measured with goniometer

  4. Knee stability

    Time frame: Pre-op, 6 weeks, 6 and 12 months post-op

    Anterior drawer, posterior drawer, valgus stress, varus stress. Instability rated for each test 1 to 3 by treating surgeon.

Other outcomes

  1. Intra-operative procedures

    Time frame: At the time of surgery

    During surgery, the knee for additional intra-operative procedures to obtain a stable knee replacement will be noted:

    • Need for ligamentous release - lateral release, medial release, lateral retinaculum release, posterior cruciate ligament release
    • Need for tibial or femoral recut

  2. Surgical cost

    Time frame: At the time of surgery

    Total cost of implants and equipment used will be calculated at the end of each surgical case.

  3. Surgical time

    Time frame: At the time of surgery

    The time from first incision to skin closure will be noted at each surgery.

  4. Intra-operative complications

    Time frame: At the time of surgery

    The incidence of intra-operative complications will be noted:

    • Unplanned ligament injury
    • Neurovascular damage
    • Intra-operative tibial of femoral fracture
    • Any other complications noted during surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Samuel Larrivée, MD, MSc, FRCSC

CONTACT

[email protected]

450-466-4333 ext. 2

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • Hopital Charles Lemoyne

Registry information

Official study title

L'Alignement cinématique Dans Les prothèses de Totales de Genou : un Essai randomisé contrôlé à Double Insu Comparant la Robotique Aux Instruments Traditionnels

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 29, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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