Mechanical Alignment Versus Kinematic Alignment Total Knee Arthroplasty

NCT06486714 | Not Yet Recruiting DMC

• 1 other identifier: 217306
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

Historically, total knee arthroplasty (TKA) has been performed with the goal of restoring a neutral mechanical axis, eliminating the average 3 degrees of valgus and varus of the distal femur and proximal tibia joint lines respectively. This is thought to provide a more stable and neutral joint-bearing surface. Because of this shift to a 0-degree knee angle, soft tissue releases are frequently required to balance the knee after making the distal tibia and proximal tibia cuts. More recently and increasingly, TKAs have been performed with a goal of restoring kinematic, or anatomic, alignment of the knee. This is thought to provide a more normal native knee angle, with the hopes of precluding the necessity of soft tissue releases to balance the knee. While some studies are promising regarding kinematically aligned TKAs (KA-TKA), at present, it is unclear how these compare to mechanically aligned TKAs (MA-TKA) in terms of patient reported outcome measures (PROM) when compared head-to-head. This study will randomize patients to receive either cemented MA-TKA or KA-TKA with the goal of assessing pain scores and PROMs at various time points following surgery.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Knee Injury and Osteoarthritis Outcome Score (KOOS) Jr Score

  The KOOS Jr Score is a patient-reported outcome measure, scaled from 0-28, with higher scores meaning worse outcomes.

  Baseline, 2 weeks post op, 6 weeks post op, 1 week post op

Secondary Outcomes (1)

• Patient Reported Outcome Measure Information System (PROMIS) Physical Function

  Baseline, 2 weeks post op, 6 weeks post op, 1 week post op

Other Outcomes (4)

• Patient Reported Outcome Measure Information System (PROMIS) Pain Interference

  Baseline, 2 weeks post op, 6 weeks post op, 1 week post op

• Forgotten Joint Score

  Baseline, 2 weeks post op, 6 weeks post op, 1 week post op

• Pain Visual Analogue Scale

  Baseline, 2 weeks post op, 6 weeks post op, 1 week post op

Study Arms (2)

Kinematic Total Knee Arthroplasty

EXPERIMENTAL

KA-TKAs recreate the native joint line, hip-knee-ankle angle, and rotation of the pre-arthritic joint.

Procedure: Total knee arthroplasty

Mechanical Total Knee Arthroplasty

ACTIVE COMPARATOR

MA-TKAs are performed by which the distal femur and proximal tibia cuts are made perpendicular to the mechanical axis, a line connecting the center of the femoral head to the center of the ankle. These cuts are classically described as a 6-degree valgus cut of the distal femur and a 0-degree cut of the proximal tibia in relation to the mechanical axis. MA-TKAs create a 0-degree hip-knee-ankle angle.

Procedure: Total knee arthroplasty

Interventions

Total knee arthroplasty PROCEDURE

All patients indicated for primary total knee arthroplasty will receive a cruciate-retaining cemented or cementless implant system, utilizing either MA or KA methodology.

Kinematic Total Knee Arthroplasty; Mechanical Total Knee Arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years or older presenting to our institutions indicated for a primary total knee arthroplasty

You may not qualify if:

• Revision TKA
• Patients with prior injuries to study knee
• Patients with history of childhood knee disease
• Patients who cannot complete questionnaires in English
• Patients with comorbidities preventing surgery
• Patients who are not able to provide informed consent

Sponsors & Collaborators

• Loyola University: lead

Related Publications (12)

• Blakeney W, Clement J, Desmeules F, Hagemeister N, Riviere C, Vendittoli PA. Kinematic alignment in total knee arthroplasty better reproduces normal gait than mechanical alignment. Knee Surg Sports Traumatol Arthrosc. 2019 May;27(5):1410-1417. doi: 10.1007/s00167-018-5174-1. Epub 2018 Oct 1.

  PMID: 30276435 BACKGROUND

• 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

• Jaffe WL, Dundon JM, Camus T. Alignment and Balance Methods in Total Knee Arthroplasty. J Am Acad Orthop Surg. 2018 Oct 15;26(20):709-716. doi: 10.5435/JAAOS-D-16-00428.

  PMID: 30134305 BACKGROUND

• Lee YS, Howell SM, Won YY, Lee OS, Lee SH, Vahedi H, Teo SH. Kinematic alignment is a possible alternative to mechanical alignment in total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2017 Nov;25(11):3467-3479. doi: 10.1007/s00167-017-4558-y. Epub 2017 Apr 24.

  PMID: 28439636 BACKGROUND

• Li Y, Wang S, Wang Y, Yang M. Does Kinematic Alignment Improve Short-Term Functional Outcomes after Total Knee Arthroplasty Compared with Mechanical Alignment? A Systematic Review and Meta-analysis. J Knee Surg. 2018 Jan;31(1):78-86. doi: 10.1055/s-0037-1602136. Epub 2017 May 1.

  PMID: 28460408 BACKGROUND

• Luceri F, Sosio C, Sirtori P, Battistella D, Zuffada M, Ulivi M, Meroni V, Marmotti A, Mangiavini L, Peretti GM. Kinematic versus mechanical alignment in total knee arthroplasty: a preliminary study. J Biol Regul Homeost Agents. 2020 Jul-Aug;34(4 Suppl. 3):139-143. Congress of the Italian Orthopaedic Research Society.

  PMID: 33261269 BACKGROUND

• Luo Z, Zhou K, Peng L, Shang Q, Pei F, Zhou Z. Similar results with kinematic and mechanical alignment applied in total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2020 Jun;28(6):1720-1735. doi: 10.1007/s00167-019-05584-2. Epub 2019 Jun 27.

  PMID: 31250055 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

• Oussedik S, Abdel MP, Victor J, Pagnano MW, Haddad FS. Alignment in total knee arthroplasty. Bone Joint J. 2020 Mar;102-B(3):276-279. doi: 10.1302/0301-620X.102B3.BJJ-2019-1729.

  PMID: 32114811 BACKGROUND

• Riviere C, Iranpour F, Auvinet E, Howell S, Vendittoli PA, Cobb J, Parratte S. Alignment options for total knee arthroplasty: A systematic review. Orthop Traumatol Surg Res. 2017 Nov;103(7):1047-1056. doi: 10.1016/j.otsr.2017.07.010. Epub 2017 Aug 31.

  PMID: 28864235 BACKGROUND

• Tian G, Wang L, Liu L, Zhang Y, Zuo L, Li J. Kinematic alignment versus mechanical alignment in total knee arthroplasty: An up-to-date meta-analysis. J Orthop Surg (Hong Kong). 2022 Sep-Dec;30(3):10225536221125952. doi: 10.1177/10225536221125952.

  PMID: 36250421 BACKGROUND

• Weber P, Gollwitzer H. Kinematic alignment in total knee arthroplasty. Oper Orthop Traumatol. 2021 Dec;33(6):525-537. doi: 10.1007/s00064-021-00729-4. Epub 2021 Aug 19.

  PMID: 34414467 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Nicholas Brown, MD

  Loyola University Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanna House, MD

CONTACT

2602414659; hanna.e.house@luhs.org

Nicholas Brown, MD

CONTACT

3194004327; nicholas.brown002@lumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blind. The participant will be blinded to the assignment until one year after surgery. The study team and surgeon will not be blinded to the assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Our study will randomize patients to receive either cemented MA-TKA or KA-TKA with the goal of assessing pain scores and PROMs at various time points following surgery.

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 3, 2024
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share