Do Sports Compression Garments Alter Measures of Peripheral Blood Flow? A Systematic Review with Meta-Analysis.
Shane F O'Riordan, David J Bishop, Shona L Halson...
https://pubmed.ncbi.nlm.nih.gov/36622554Actively Recruiting
Phase Not Applicable
Age: 16Years - 65Years
All Genders
ID06979804
A Comparison of Outcomes After Anterior Cruciate Ligament (ACL) or Anterior Cruciate Ligament and Meniscus (ACL+Meniscus) Surgery Using Semiconductor Fabric Products: A Randomized, Double-Blinded, Placebo-Controlled Prospective Clinical Study
Led by Illinois Center for Orthopaedic Research and Education · Updated on 2025-05-22
135
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
I
Illinois Center for Orthopaedic Research and Education
Lead Sponsor
I
INCREDIWEAR HOLDINGS, INC.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of semiconductor fabric sleeves on recovery after Anterior Cruciate Ligament (ACL) or ACL plus Meniscus arthroscopic surgery. The study aims to determine whether semiconductor sleeves improve functional outcomes and if they help patients recover faster compared to placebo sleeves that look similar but contain no semiconductor material. The trial is a randomized, double-blinded, placebo-controlled prospective clinical study led by the Illinois Center for Orthopaedic Research and Education. Participants will be assigned to one of three groups: a control group receiving standard care, a group wearing semiconductor fabric sleeves, or a group wearing placebo sleeves without semiconductor material. The sleeves are worn post-operatively, with a leg sleeve worn for 4 weeks followed by a knee sleeve for 12 weeks, totaling 4 months of use. The intervention is delivered through these wearable devices, and the study compares their effects on recovery after surgery. During the study, participants will complete patient-reported outcome surveys and undergo clinical assessments including range of motion and effusion measurements up to one year after surgery. Researchers will monitor the functional progress and measure outcomes using validated tools to assess improvements. The total follow-up includes evaluations at one year to understand the longer-term effects of the sleeves on knee function after surgery.
CONDITIONS
Brief Title
A Comparison of Outcomes After Anterior Cruciate Ligament (ACL) or Anterior Cruciate Ligament and Meniscus (ACL+Meniscus) Surgery Using Semiconductor Fabric Products
Who Can Participate
Age: 16Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- History of neurological conditions such as multiple sclerosis or Parkinson's disease
- Severe medical conditions including recent myocardial infarction, unstable angina, heart failure, severe anemia
- Prior surgical treatment of the knee in the last 5 years or injection treatment(s) in the last 6 months
- Chronic pain conditions unrelated to knee condition
- Auto-immune or auto-inflammatory diseases
- Poorly controlled diabetes (HgA1c > 7.5)
- Body Mass Index (BMI) > 39.9
- Varicosities on the operative leg
- Severe peripheral artery disease (ABI < 0.6)
- Considered a pain management patient
- Previous blood clots or stroke
- Use of tobacco within the last 90 days
- Active infection or open wound in the areas of product application
- Unwilling or unable to sign the research consent/assent form
- Any other condition that may prevent study completion or confound results as per investigator opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Surgery day and immediate post-operative period
Participants undergo ACL or ACL+Meniscus surgery followed by immediate post-operative care.
1 surgical visit and immediate post-operative assessments
Implementation
Duration - 4 months post-operatively
Participants wear semiconducting or non-semiconducting fabric sleeves for support during recovery.
Regular visits during the 4 months for sleeve use monitoring
Post-operative Follow-up
Duration - Up to 1 year after surgery
Participants are followed to assess recovery outcomes including range of motion and patient-reported outcomes.
Periodic follow-up visits over 1 year
Trial Site Locations
Total: 1 location
1
Illinois Bone and Joint Institute
Westmont, Illinois, United States, 60559
Actively Recruiting
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Research Team
R
Ronak M Patel, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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T Elaine Justice, Paul B Jacob
https://pubmed.ncbi.nlm.nih.gov/38094981