Evaluating different alignment techniques in knee replacement surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: alex.knisely@exac.com
• Phone: 352-474-9582

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.