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 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 12:56 AM
NCT ID:
NCT02885467
Eligibility Criteria:
Inclusion Criteria:
* Must have symptomatic knee osteoarthritis under consideration for total knee arthroplasty
* Must be willing to undergo randomization
Exclusion Criteria:
* Age \<18 or \>80 years
* Known pre-operative diagnosis of neuralgia, complex regional pain syndrome, or neuropathy, about the operative lower extremity
* Known pre-operative psychiatric disorder requiring medication
* Previous surgery about the operative knee
* BMI \> 40 kg/m2 (potential increased risk of soft tissue dissection through adipose)
* Ongoing pre-operative narcotic use in excess of 20 mg morphine equivalents per day for at least one month or pre-operative intravenous drug use (increased potential for complex regional pain syndrome and neuralgia, increased likelihood to require greater post-operative analgesia)
* Ongoing pre-operative use of neuropathic pain medications (gabapentin, pregabalin, amitriptyline, etc.)
* Medical comorbidities (American Society of Anesthesiologists grade \> 3 or deemed unfit by consulting internist) precluding elective TKA
* Significant language barrier (reading comprehension less than 8th grade reading level) or mental condition precluding accurate self-assessment of knee pain or function.
* Severe medication allergies to permissible post-operative analgesics (acetaminophen, tramadol, oxycodone, oxycontin, dilaudid)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02885467
Study Brief:
Protocol Section:
NCT02885467