Knee Arthroplasty, Total
Conditions
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.
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.
Interventions
DEVICEOptetrak 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.
Sponsors
Exactech
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
Intervention model description
Randomization list (block randomized, computer generated, two equal-size groups) will be created within the EDC system
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Score (KSS) | 3-month | Validated outcome score |
| Forgotten Joint Score (FJS) | 3-month | Validated outcome score |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | 3-month | Validated outcome score |
| Visual Analog Scale (VAS) - Pain | 3-month | Visual scale from 1-10 (low score is better) |
| Visual Analog Scale (VAS) - Patient Satisfaction | 3-month | Visual scale from 1-10 (high score is better) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Alignment | Intraoperative | Characterization of knee in terms of ligament balancing will be assessed through constant-pressure full arc of motion measurement. |
Countries
Spain
Contacts
Primary ContactAlex Knisely, BSBA
Backup ContactAmanda Ford, PhD
Outcome results
None listed