Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment

Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment on Patient Reported Outcome Measures (PROMs): A Prospective, Randomized Clinical Study

The purpose of this study is to evaluate both clinical measures and PROMs in patients undergoing total knee arthroplasty (TKA) using restricted inverse kinematic alignment (iKA) compared to mechanical alignment (MA), both using surgical navigation assistance.

Study Overview

• Status: Recruiting
• Conditions: Knee Arthroplasty, Total
• Intervention / Treatment: Device: Optetrak Logic CR Knee System

Detailed Description

A prospective randomized clinical study will be conducted.

The study will consist of two cohorts and will collect clinical data from a maximum of 148 knee arthroplasty surgeries during which the patient will receive the Optetrak Logic® CR TKA device. Cohorts will consist of 1) subjects undergoing MA TKA and 2) subjects undergoing restricted iKA TKA. All cohorts will utilize navigation-assisted surgery (ExactechGPS®) and will be enrolled and consented concurrently. Subjects will be randomized and have a 50% chance of being assigned to the MA TKA cohort and a 50% chance of being assigned to the restricted iKA TKA cohort. Study and research staff will be blinded to randomization and the cohort allocation until after consenting and eligibility is determined. Subjects will be blinded to the randomization (MA TKA or restricted iKA TKA) until the completion of the study.

Data collection under this protocol shall be conducted in a way that conforms to any applicable local and national rules, regulations, and guidelines relating to the conduct of clinical research and the protection of human subjects. As appropriate, this may include but is not limited to the following: Good Clinical Practice (GCP) requirements, FDA regulations and guidelines, ISO 14155: 2020, ICH guidelines, HIPAA and other regulations pertaining to the protection of patient data and data privacy, guidelines established by local Institutional Review Boards or similar Ethics Committees, the Belmont Report, and the Declaration of Helsinki.

• Study Type: Interventional
• Enrollment (Estimated): 148
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alex Knisely, BSBA; Phone Number: 352-474-9582; Email: alex.knisely@exac.com
• Study Contact Backup: Name: Amanda Ford, PhD; Email: amanda.ford@exac.com

Study Locations

• Spain
  • Barcelona, Spain
    • Recruiting
    • Fundacio Mutua de Terrassa per a la Docenia i Recera Biomedica i Social, F.P.C.
    • Contact: Pilar A Sola; Phone Number: 11801 93 736 50 50; Email: parcusa@muturterrassa.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subjects must meet all of the following inclusion criteria to be included in the study:

  1. Subject must be at least 18 years of age at the time of the surgery (skeletally mature)
  2. Subject will receive a Optetrak Logic® CR device per the "Indications for Use" described above
  3. Subject must be willing to comply with the pre-operative and post-operative visit requirements
  4. Subject must be willing and able to provide written informed consent for participation in the study

Exclusion Criteria:

• Subjects will be excluded from the study if they meet any of the following exclusion criteria:

  1. Subject with a suspected or confirmed systemic infection and/or a secondary remote infection
  2. Subject without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis
  3. Subject without sufficient soft tissue integrity to provide adequate stability
  4. Subject with either mental or neuromuscular disorders that do not allow control of the knee joint
  5. Subjects whose weight, age, or activity level might cause extreme loads and early failure of the system
  6. Subject is participating in another drug or device study other than knee replacement within the last three (3) months
  7. Subject has behavioral and/or mental issues that may interfere with their ability to follow post-operative instructions
  8. Subject is a prisoner
  9. Subject is pregnant
  10. Subject is undergoing radiation therapy where the targeted field involves the knee joint
  11. Subjects with malignancy involving proximal tibia, distal femur, or knee joint
  12. Subjects undergoing active administration of chemotherapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Restricted Invers Kinematic Knee Alignment Technique	Device: Optetrak Logic CR Knee System; The OPTETRAK® Comprehensive Knee System consists of the OPTETRAK® Total Knee System and the OPTETRAK Logic® Total Knee System. The OPTETRAK Comprehensive Knee System comprises both non-porous and porous knee prostheses for use in total-knee joint replacement procedures. (In the USA, the OPTETRAK Comprehensive Knee System is indicated for cemented use only, except for the OPTETRAK Logic PS and CR Porous Femoral Components, which are indicated for cemented or cementless use.) The system includes various sizes and types of modular femoral components, tibial components, patellar components, and accessories for use in primary and revision applications.; Other Names: Exactech Guided Personalized Surgery
Other: Mechanical Knee Alignment Technique	Device: Optetrak Logic CR Knee System; The OPTETRAK® Comprehensive Knee System consists of the OPTETRAK® Total Knee System and the OPTETRAK Logic® Total Knee System. The OPTETRAK Comprehensive Knee System comprises both non-porous and porous knee prostheses for use in total-knee joint replacement procedures. (In the USA, the OPTETRAK Comprehensive Knee System is indicated for cemented use only, except for the OPTETRAK Logic PS and CR Porous Femoral Components, which are indicated for cemented or cementless use.) The system includes various sizes and types of modular femoral components, tibial components, patellar components, and accessories for use in primary and revision applications.; Other Names: Exactech Guided Personalized Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Society Score (KSS)	Validated outcome score	3-month
Knee Society Score (KSS)	Validated outcome score	6-month
Knee Society Score (KSS)	Validated outcome score	12-month
Forgotten Joint Score (FJS)	Validated outcome score	3-month
Forgotten Joint Score (FJS)	Validated outcome score	6-month
Forgotten Joint Score (FJS)	Validated outcome score	12-month
Knee Injury and Osteoarthritis Outcome Score (KOOS)	Validated outcome score	3-month
Knee Injury and Osteoarthritis Outcome Score (KOOS)	Validated outcome score	6-month
Knee Injury and Osteoarthritis Outcome Score (KOOS)	Validated outcome score	12-month
Visual Analog Scale (VAS) - Pain	Visual scale from 1-10 (low score is better)	3-month
Visual Analog Scale (VAS) - Pain	Visual scale from 1-10 (low score is better)	6-month
Visual Analog Scale (VAS) - Pain	Visual scale from 1-10 (low score is better)	12-month
Visual Analog Scale (VAS) - Patient Satisfaction	Visual scale from 1-10 (high score is better)	3-month
Visual Analog Scale (VAS) - Patient Satisfaction	Visual scale from 1-10 (high score is better)	6-month
Visual Analog Scale (VAS) - Patient Satisfaction	Visual scale from 1-10 (high score is better)	12-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Alignment	Characterization of knee in terms of ligament balancing will be assessed through constant-pressure full arc of motion measurement.	Intraoperative

Collaborators and Investigators

• Sponsor: Exactech
• Investigators: Principal Investigator: David Mateu-Vincent, Medical Degree, Orthpaedic Surgeon Hospital Universitaria Mutua Terrassa

Publications and helpful links

General Publications

• 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.
• Almaawi AM, Hutt JRB, Masse V, Lavigne M, Vendittoli PA. The Impact of Mechanical and Restricted Kinematic Alignment on Knee Anatomy in Total Knee Arthroplasty. J Arthroplasty. 2017 Jul;32(7):2133-2140. doi: 10.1016/j.arth.2017.02.028. Epub 2017 Feb 20.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: August 19, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (Actual): August 25, 2022

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: TM-2021-1586

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are no plans to share individual participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes