NCT05516381

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
May 2023Jun 2027

First Submitted

Initial submission to the registry

August 19, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 25, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

3.6 years

First QC Date

August 19, 2022

Last Update Submit

June 17, 2024

Conditions

Knee Arthroplasty, Total

Outcome Measures

Primary Outcomes (15)

  • 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 Outcomes (1)

  • Knee Alignment

    Intraoperative

Study Arms (2)

Restricted Invers Kinematic Knee Alignment Technique

OTHER

Restricted Invers Kinematic Knee Alignment Technique

Device: Optetrak Logic CR Knee System

Mechanical Knee Alignment Technique

OTHER

Mechanical Knee Alignment Technique

Device: Optetrak Logic CR Knee System

Interventions

Optetrak Logic CR Knee SystemDEVICE

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.

Also known as: Exactech Guided Personalized Surgery
Mechanical Knee Alignment TechniqueRestricted Invers Kinematic Knee Alignment Technique

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundacio Mutua de Terrassa per a la Docenia i Recera Biomedica i Social, F.P.C.

Barcelona, Spain

RECRUITING

Related Publications (2)

  • 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: 32737528BACKGROUND

  • 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.

    PMID: 28302462BACKGROUND

Study Officials

  • David Mateu-Vincent, Medical Degree

    Orthpaedic Surgeon Hospital Universitaria Mutua Terrassa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex Knisely, BSBA

CONTACT

352-474-9582alex.knisely@exac.com

Amanda Ford, PhD

CONTACT

amanda.ford@exac.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
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.
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Randomization list (block randomized, computer generated, two equal-size groups) will be created within the EDC system
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2022

First Posted

August 25, 2022

Study Start

May 15, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

June 18, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

There are no plans to share individual participant data

Locations

ES(1)