Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT02863120
Eligibility Criteria:
Inclusion Criteria:
* Male or non-pregnant female between the ages of 18-65
* Patients willing and able to sign the informed consent
* Patients able to comply with follow-up requirements including self-evaluations
* Patients requiring a primary total knee replacement
* Patients with a diagnosis of osteoarthritis, traumatic arthritis, or avascular necrosis
Exclusion Criteria:
* Revision total knee arthroplasty
* Bilateral total knee arthroplasty
* Patients with inflammatory arthritis
* Patients with a body mass index (BMI) \> 40
* Allergy to ropivacaine, bupivacaine, or other local anesthetic agents
* Current use of opioid drugs
* Patients with a history of total or unicompartmental reconstruction of the affected joint
* Patients that have had a high tibial osteotomy or femoral osteotomy
* Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess pain levels
* Patients with a systemic or metabolic disorder leading to progressive bone deterioration
* Patients that are immunologically compromised, or receiving chronic steroids (\>30 days), excluding inhalers
* Patients' bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis
* Patients with knee fusion to the affected joint
* Patients with an active or suspected latent infection in or about the knee joint
* Patients that are prisoners
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02863120
Study Brief:
Protocol Section:
NCT02863120