Evaluating different alignment techniques in knee replacement surgery

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

This study is testing two different knee replacement surgery techniques to see which one helps patients recover better and feel happier after the operation.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 148 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Exactech (industry)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Barcelona)
• Trial ID: NCT05516381 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare two surgical techniques for total knee arthroplasty (TKA): mechanical alignment (MA) and restricted inverse kinematic alignment (iKA), both assisted by navigation technology. A total of 148 patients will be randomly assigned to one of the two techniques using the Optetrak Logic® CR TKA device. The study will assess clinical outcomes and patient-reported outcome measures (PROMs) to determine the effectiveness of each approach. Participants will be blinded to their assigned technique until the study's completion.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who require total knee arthroplasty and can provide informed consent.

Not a fit: Patients with systemic infections, inadequate bone stock, or significant mental or neuromuscular disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and patient satisfaction in knee replacement surgeries.

How similar studies have performed: Previous studies have shown promising results with navigation-assisted techniques in knee arthroplasty, suggesting potential for success in this approach.

Eligibility criteria

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

Where this trial is running

Barcelona

• Fundacio Mutua de Terrassa per a la Docenia i Recera Biomedica i Social, F.P.C. — Barcelona, Spain (RECRUITING)

Study contacts

• Principal investigator: David Mateu-Vincent, Medical Degree — Orthpaedic Surgeon Hospital Universitaria Mutua Terrassa
• Study coordinator: Alex Knisely, BSBA

Conditions: Knee Arthroplasty, Total