Status:
RECRUITING
A Comparison of Outcomes After Anterior Cruciate Ligament (ACL) or Anterior Cruciate Ligament and Meniscus (ACL+Meniscus) Surgery Using Semiconductor Fabric Products
Lead Sponsor:
Illinois Center for Orthopaedic Research and Education
Collaborating Sponsors:
INCREDIWEAR HOLDINGS, INC.
Conditions:
ACL Reconstruction
Meniscus Tears
Eligibility:
All Genders
16-65 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to determine the effect of semiconductor sleeves on the treatment of Anterior Cruciate Ligament (ACL) or Anterior Cruciate Ligament and Meniscus (ACL+Meniscus) arthr...
Eligibility Criteria
Inclusion
- Patients undergoing ACL or ACL+Meniscus surgery
- Age 16 - 65
- Patients with Body Mass Index (BMI) \<40
- Patients who are willing and able to adhere to follow-up schedule and protocol guidelines.
- Patients who are willing and able to sign corresponding research subject consent/assent form.
Exclusion
- Patient has a history of neurological conditions, including multiple sclerosis or Parkinson's disease
- Patient has severe medical condition, including recent myocardial infarction, unstable angina, heart failure, severe anemia
- Patient has had prior surgical treatment of the knee in the last 5 years or injection treatment(s) in the last 6 months
- Patient has chronic pain conditions unrelated to knee condition
- Patient has auto-immune or auto-inflammatory diseases
- Patient has poorly controlled diabetes (HgA1c \> 7.5)
- Patient has BMI \> 39.9
- Patient has varicosities on the operative leg
- Patient has severe peripheral artery disease (ABI \< 0.6)
- Patient is considered a pain management patient
- Patient has had previous blood clots or stroke
- Patient has used tobacco within the last 90 days
- Patient is not within the ages of 16-65
- Patient has an active infection (local or systemic), or an open (non-surgical) wound in the areas of product application
- Patient is unwilling or unable to sign the corresponding research subject consent/assent form
- Patient meets any other criteria or has any other condition that, in the opinion of the investigator, would prevent them from completing the study or that, in the opinion of the investigator, would confound study results.
Key Trial Info
Start Date :
September 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT06979804
Start Date
September 11 2024
End Date
October 1 2026
Last Update
May 22 2025
Active Locations (1)
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1
Illinois Bone and Joint Institute
Westmont, Illinois, United States, 60559