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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06709703
• Lead Sponsor: Université de Sherbrooke

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-11-25
• Last Update Submitted: 2024-11-25
• Study First Posted: 2024-11-28
• Last Update Posted: 2024-11-28
• Study Start: 2025-02
• Primary Completion: 2028-07
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Radiographic alignment of the knee	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.
Knee Injury and Osteoarthritis Outcome Score (KOOS)	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.
Forgotten joint score	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.
Joint perception question	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 Outcome Measures

Name	Time	Method
Pain visual analog scale	Pre-op, 6 weeks, 6, 12, 24 months	Pain rated on a 10 cm visual analog scale from "no pain" to "worst pain imaginable"
Subjective Assessment Numeric Evaluation Scale (SANE)	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)
Knee range of motion	Pre, 6 weeks, 6 and 12 months post-op	Maximum passive flexion and extension measured with goniometer
Knee stability	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.