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

NCT06709703 | Not Yet Recruiting FDA Device

• 1 other identifier: 2025-958
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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:

• 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.

Conditions

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

Keywords

osteoarthritis; arthritis; knee osteoarthritis; knee OA; knee arthritis; total knee replacement; robotic; kinematic alignment; patient-specific surgery

Outcome Measures

Primary Outcomes (4)

• Radiographic alignment of the knee

  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.

  Pre-operative alignement and 6 months post-operative alignement.

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  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.

  Pre-operative, 6 weeks, 6 months, 12 months, 24 months post-operative

• Forgotten joint score

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

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

• Joint perception question

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

  Pre-operative, 6 weeks, 6 months, 12 months and 24 months post-operative

Secondary Outcomes (4)

• Pain visual analog scale

  Pre-op, 6 weeks, 6, 12, 24 months

• Subjective Assessment Numeric Evaluation Scale (SANE)

  Pre-op, 6 weeks, 6, 12, 24 months

• Knee range of motion

  Pre, 6 weeks, 6 and 12 months post-op

• Knee stability

  Pre-op, 6 weeks, 6 and 12 months post-op

Other Outcomes (4)

• Intra-operative procedures

  At the time of surgery

• Surgical cost

  At the time of surgery

• Surgical time

  At the time of surgery

Study Arms (2)

Kinematic knee replacement with traditional instruments

ACTIVE COMPARATOR

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

Procedure: Kinematic aligned total knee replacement

Robotic-assisted kinematic knee replacement

EXPERIMENTAL

Patients will undergo kinematic aligned knee replacement done using robotic assistance

Procedure: Kinematic aligned total knee replacement

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.

Kinematic knee replacement with traditional instruments; Robotic-assisted kinematic knee replacement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Hopital Charles Lemoyne: collaborator

Related Publications (5)

• 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.

  PMID: 33547914 BACKGROUND

• 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.

  PMID: 32234326 BACKGROUND

• 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.

  PMID: 36403396 BACKGROUND

• 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.

  PMID: 24986944 BACKGROUND

• 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.

  PMID: 37165209 BACKGROUND

MeSH Terms

Conditions

Arthritis; Osteoarthritis; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Samuel Larrivée, MD, MSc, FRCSC

CONTACT

450-466-4333; samuel.larrivee@usherbrooke.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Statistician will be blinded to the intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon

Model Details: Double-blind randomized controlled-trial

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 29, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share