A Comparison of Outcomes After Anterior Cruciate Ligament (ACL) or Anterior Cruciate Ligament and Meniscus (ACL+Meniscus) Surgery Using Semiconductor Fabric Products
Launched by ILLINOIS CENTER FOR ORTHOPAEDIC RESEARCH AND EDUCATION · May 12, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether special fabric sleeves containing semiconductor materials can improve recovery after surgery for a torn ACL (anterior cruciate ligament) or combined ACL and meniscus injuries. The main focus is to see if these sleeves help patients recover faster and better than a regular sleeve that doesn’t have the semiconductor material. Participants will wear either the semiconductor sleeve or a look-alike placebo sleeve for four weeks, followed by a knee sleeve for an additional twelve weeks. They will also complete surveys to share how they feel about their recovery.
To join the trial, participants must be between 16 and 65 years old and planning to have surgery for an ACL or ACL+meniscus injury. They should have a body mass index (BMI) under 40 and be able to follow the study rules. However, individuals with certain medical conditions, recent knee surgeries, or other specific health issues will not be eligible to participate. Those who take part will contribute to important research that could help improve recovery options for future patients with similar injuries.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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.
About Illinois Center For Orthopaedic Research And Education
The Illinois Center for Orthopaedic Research and Education (ICORE) is a leading clinical trial sponsor dedicated to advancing orthopedic care through innovative research and evidence-based practices. Committed to improving patient outcomes, ICORE collaborates with healthcare professionals, academic institutions, and industry partners to conduct rigorous clinical trials that evaluate new treatments, surgical techniques, and rehabilitation protocols. With a focus on translating research into practice, ICORE aims to enhance the understanding of musculoskeletal disorders and foster the development of cutting-edge therapies that meet the evolving needs of patients and clinicians alike.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Westmont, Illinois, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported