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New treatment option for ACL Reconstruction
Official title A Comparison of Outcomes After Anterior Cruciate Ligament (ACL) or Anterior Cruciate Ligament and Meniscus (ACL+Meniscus) Surgery Using Semiconductor Fabric Products
ClinicalTrials.gov ID: NCT06979804
What this study is testing
- What it's testing
- 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) arthroscopic surgery. The effect of the sleeves will be analyzed through patient reported and clinically measured outcomes.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 65
You may be able to join if
- 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.
You likely can't join if
- 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)
See the full eligibility 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Westmont, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Westmont, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.