Comparison of Functional Recovery Between Restricted Inverse Kinematic Alignment and Adjusted Mechanical Alignment With Robotic-assisted Unilateral Total Knee Arthroplasty.

NCT06835621 | Not Yet Recruiting

• 1 other identifier: MTU-EC-OT-0-240/67
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to learn if restricted inverse kinematic alignment total knee arthroplasty (restricted iKA TKA) improves functional recovery compared to adjusted mechanical alignment total knee arthroplasty (aMA TKA) in patients undergoing unilateral robotic-assisted total knee arthroplasty by comparing performance-based outcome, 2-minute walk test (2MWT) as a primary outcome. This trial will also assess other outcomes including satisfaction, patient-reported functional outcomes, range of motion, visual analog scale for pain and complication of both techniques. The main question aims to answer is: In unilateral robotic-assisted total knee arthroplasty, dose Restricted iKA technique provide better postoperative performance-based outcome compared to aMA technique? Researchers will compare restricted iKA and aMA technique to determine which technique offers better acceleration in functional recovery and patient satisfaction. Participants will: After randomization, participants will allocate to either restricted iKA or aMA technique for unilateral robotic-assisted total knee arthroplasty. Attend follow-up visits for assessments of 2-minute walk test (Primary outcome), Time up and go test (TUG), VAS for pain, ROM and complete patient-reported functional outcome questionnaires regarding knee function and satisfaction at regular intervals.

Conditions

OA Knee; TKA

Keywords

Osteoarthritis (OA) of the Knee; OA knee; MAKO; Kinematic alignment; Mechanical alignment; Restricted Kinematic alignment; Inversed Kinematic alignment; Inversed Restricted Kinematic alignment; Robotic assist Total Knee Arthroplasty; Adjusted mechanical alignment

Outcome Measures

Primary Outcomes (1)

• 2-minute walk test

  The 2-minute walk test (2mwt) is a performance-based test that evaluates functional recovery after total knee arthroplasty (TKA) by measures the distance a person can walk in two minutes (meters) and has been validated as performance-based test with responsiveness properties. Being simple and easy to perform, it can be used routinely in clinical practice to evaluate functional recovery after TKA.

  From enrollment (preoperative measurement) to the end of postoperative follow-up (2 years)

Secondary Outcomes (12)

• Time up and go test

  From enrollment (preoperative measurement) to the end of postoperative follow-up (2 years)

• modified WOMAC scale for knee pain (Thai version)

  From enrollment (preoperative measurement) to the end of postoperative follow-up (2 years)

• Thai version of the Forgotten Joint Score

  From enrollment (preoperative measurement) to the end of postoperative follow-up (2 years)

• Oxford knee score

  From enrollment (preoperative measurement) to the end of postoperative follow-up (2 years)

• Range of Motion

  From enrollment (preoperative measurement) to the end of postoperative follow-up (2 years)

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Restricted inverse kinematic alignment

Procedure: Restricted inverse kinematic alignment Total Knee Arthroplasty

Group 2

ACTIVE COMPARATOR

Adjusted mechanical alignment

Procedure: Adjusted Mechanical alignment Total Knee Arthroplasty

Interventions

Restricted inverse kinematic alignment Total Knee Arthroplasty PROCEDURE

Restricted inverse kinematic alignment (restricted iKA) total knee arthroplasty is an alignment technique of total knee replacement surgery, aim to maintain the native coronal alignment within a HKA angle safe zone of 177° to 183°. This technique aims to 'resurface' the femur maintaining the native femoral joint line obliquity, with the flexion and extension gaps balanced by adjusting the tibial resection first. It is considered a more personalized approach because it aims to replicate the knee's pre-arthritic alignment and movement, believing that each patient's knee has a unique alignment.

Also known as: Restricted kinematic alignment, rKA, Inverse kinematic alignment, iKA, Restricted iKA

Group 1

Adjusted Mechanical alignment Total Knee Arthroplasty PROCEDURE

The adjusted Mechanical Alignment (aMA) technique is an adaptation of the conventional MA technique but with undercorrection of constitutional coronal deformity, within a limit of ± 3°. The femoral resection is adjusted to preserve mild constitutional deformity and/or reduce more severe deformity while leaving the tibial component mechanically aligned. The tibial component was positioned with the aim to be perpendicular (90°) to the mechanical tibial axis.

Also known as: aMA

Group 2

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50 - 80 years old
• Diagnosed with primary OA knee and indicated for unilateral total knee arthroplasty with MAKO robotic-assisted knee replacement system
• ASA classification I-II

You may not qualify if:

• Valgus deformity
• KL grading \> 3 on contralateral knee
• Unable or difficulty for walking due to comorbidities
• BMI \> 40 kg/m2
• Previous knee surgery
• Infection around the knee

Sponsors & Collaborators

• Thammasat University: lead

Study Sites (2)

Faculty of Medicine, Thammasat University

Klongluang, Changwat Pathum Thani, 12120, Thailand

Location

Faculty of Medicine, Thammasat University

Klongluang, Changwat Pathum Thani, 12120, Thailand

Location

Related Publications (15)

• Elbuluk AM, Jerabek SA, Suhardi VJ, Sculco PK, Ast MP, Vigdorchik JM. Head-to-Head Comparison of Kinematic Alignment Versus Mechanical Alignment for Total Knee Arthroplasty. J Arthroplasty. 2022 Aug;37(8S):S849-S851. doi: 10.1016/j.arth.2022.01.052. Epub 2022 Jan 31.

  PMID: 35093548 BACKGROUND

• McEwen PJ, Dlaska CE, Jovanovic IA, Doma K, Brandon BJ. Computer-Assisted Kinematic and Mechanical Axis Total Knee Arthroplasty: A Prospective Randomized Controlled Trial of Bilateral Simultaneous Surgery. J Arthroplasty. 2020 Feb;35(2):443-450. doi: 10.1016/j.arth.2019.08.064. Epub 2019 Sep 5.

  PMID: 31591010 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

• Blakeney WG, Vendittoli PA. Restricted Kinematic Alignment: The Ideal Compromise? 2020 Jul 1. In: Riviere C, Vendittoli PA, editors. Personalized Hip and Knee Joint Replacement [Internet]. Cham (CH): Springer; 2020. Chapter 17. Available from http://www.ncbi.nlm.nih.gov/books/NBK565760/

  PMID: 33347126 BACKGROUND

• Howell SM, Shelton TJ, Hull ML. Implant Survival and Function Ten Years After Kinematically Aligned Total Knee Arthroplasty. J Arthroplasty. 2018 Dec;33(12):3678-3684. doi: 10.1016/j.arth.2018.07.020. Epub 2018 Jul 31.

  PMID: 30122435 BACKGROUND

• Vanlommel L, Vanlommel J, Claes S, Bellemans J. Slight undercorrection following total knee arthroplasty results in superior clinical outcomes in varus knees. Knee Surg Sports Traumatol Arthrosc. 2013 Oct;21(10):2325-30. doi: 10.1007/s00167-013-2481-4. Epub 2013 Apr 4.

  PMID: 23552665 BACKGROUND

• Winnock de Grave P, Luyckx T, Claeys K, Tampere T, Kellens J, Muller J, Gunst P. Higher satisfaction after total knee arthroplasty using restricted inverse kinematic alignment compared to adjusted mechanical alignment. Knee Surg Sports Traumatol Arthrosc. 2022 Feb;30(2):488-499. doi: 10.1007/s00167-020-06165-4. Epub 2020 Jul 31.

  PMID: 32737528 BACKGROUND

• Yang Y, Wang Y, Chen Y, Wang J, Lu B, Zhu W, Zhu J, Zhu C, Zhang X. Tracing the evolution of robotic-assisted total knee arthroplasty: a bibliometric analysis of the top 100 highly cited articles. J Robot Surg. 2023 Dec;17(6):2973-2985. doi: 10.1007/s11701-023-01742-4. Epub 2023 Oct 26.

  PMID: 37882976 BACKGROUND

• Vendittoli PA, Martinov S, Blakeney WG. Restricted Kinematic Alignment, the Fundamentals, and Clinical Applications. Front Surg. 2021 Jul 20;8:697020. doi: 10.3389/fsurg.2021.697020. eCollection 2021.

  PMID: 34355018 BACKGROUND

• Hirschmann MT, Becker R, Tandogan R, Vendittoli PA, Howell S. Alignment in TKA: what has been clear is not anymore! Knee Surg Sports Traumatol Arthrosc. 2019 Jul;27(7):2037-2039. doi: 10.1007/s00167-019-05558-4. Epub 2019 Jun 12. No abstract available.

  PMID: 31190246 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

• Roth JD, Howell SM, Hull ML. Native Knee Laxities at 0 degrees , 45 degrees , and 90 degrees of Flexion and Their Relationship to the Goal of the Gap-Balancing Alignment Method of Total Knee Arthroplasty. J Bone Joint Surg Am. 2015 Oct 21;97(20):1678-84. doi: 10.2106/JBJS.N.01256.

  PMID: 26491132 BACKGROUND

• Brar AS, Howell SM, Hull ML, Mahfouz MR. Does Kinematic Alignment and Flexion of a Femoral Component Designed for Mechanical Alignment Reduce the Proximal and Lateral Reach of the Trochlea? J Arthroplasty. 2016 Aug;31(8):1808-13. doi: 10.1016/j.arth.2016.01.040. Epub 2016 Feb 4.

  PMID: 26923495 BACKGROUND

• Hiranaka T, Suda Y, Saitoh A, Tanaka A, Arimoto A, Koide M, Fujishiro T, Okamoto K. Current concept of kinematic alignment total knee arthroplasty and its derivatives. Bone Jt Open. 2022 May;3(5):390-397. doi: 10.1302/2633-1462.35.BJO-2022-0021.R2.

  PMID: 35532356 BACKGROUND

• Nisar S, Palan J, Riviere C, Emerton M, Pandit H. Kinematic alignment in total knee arthroplasty. EFORT Open Rev. 2020 Aug 1;5(7):380-390. doi: 10.1302/2058-5241.5.200010. eCollection 2020 Jul.

  PMID: 32818065 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Chananyu Susrivaraput, M.D.

CONTACT

+66989169544; chananyu.atom@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 19, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2028
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

TH (2)