Illinois Bone and Joint Institute
Westmont, Illinois, 60559, United States
Location status: Recruiting
Location contact
CONTACT
NCT Number: NCT06979804
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. The main questions it aims to answer are:
* Do the semiconductor sleeves improve the functional outcomes compared to the placebo? * Will patients experience improved functional outcomes in a shorter period of time compared to the placebo?
Researchers will compare semiconductor fabric sleeves to a placebo (a look-alike sleeve that contains no semiconductor material) to see if the semiconductor fabric better treats ACL and ACL+meniscus surgical patients.
Participants will:
* Wear semiconductor or placebo leg sleeve for 4 weeks and knee sleeve for the following 12 weeks * Complete patient reported outcome surveys
Interested in participating?
Request Info16 year–65 year
All sexes
Interventional
Not applicable
Westmont, Illinois, 60559, United States
Location status: Recruiting
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This intervention includes semiconductor embedded sleeves that patients will wear for 4 months post-operatively.
This intervention includes sleeves absent of semiconductors that will be worn for 4 months post-operatively.
Time frame: 1 year
Measured extension and flexion values using a goniometer at baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year time points
Time frame: 1 year
Effusion is measured by taking the circumference using a soft measuring tape at the following points:
Time frame: 1 year
Visual Analog Scale (VAS) - assess pain, It is a 0-100 scale. A higher score indicates greater pain intensity.
Time frame: 1 year
International Knee Documentation Committee (IKDC) - assesses symptoms and function in daily living activities
Time frame: 1 year
Knee Single Assessment Numeric Evaluation (SANE) - assess knee function on a scale of 0 to 100, with 100 representing normal function
Time frame: 1 year
Tegner Activity Scale - assesses work/sport activities level on a scale of 0 to 10, with 0 representing sick leave and 10 representing elite competitive sports.
Time frame: 1 year
Lysholm Scale - assesses pain, instability, locking, swelling, limp, stair-climbing, squatting, and use of support after ligament surgery on a scale of 0 to 100.
Time frame: 1 year
Knee injury and Osteoarthritis Outcome Score Jr (KOOS Jr) - assess five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. It is a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems
Contact information is provided by the study sponsor or research team.
Illinois Center for Orthopaedic Research and Education
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07049484
ACL Injuries, ACL Reconstruction
Bologna, Italy
View Trial DetailsNCT07589309
ACL Injury, ACL Reconstruction
Lahore, Punjab Province, Pakistan
View Trial DetailsNCT06885372
ACL Reconstruction, Anterior Cruciate Ligament Injuries
Banff, Alberta, Canada
View Trial DetailsNCT07259083
ACL Reconstruction, Anterior Cruciate Ligament Injuries
Linz, Austria
View Trial Details