A Comparison of Outcomes After Anterior Cruciate Ligament (ACL) or Anterior Cruciate Ligament and Meniscus (ACL+Meniscus) Surgery Using Semiconductor Fabric Products

Part of paid clinical trials in Westmont, Illinois.

Sponsor
Illinois Center for Orthopaedic Research and Education
Study ID
NCT06979804
Status
Recruiting
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Conditions

  • ACL Reconstruction
  • Anterior Cruciate Ligament Rupture
  • Meniscus Tears

Eligibility Criteria

Sex
ALL
Age
16 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Semiconducting fabric sleeves — DEVICE
    This intervention includes semiconductor embedded sleeves that patients will wear for 4 months post-operatively.
  • Non-semiconducting fabric sleeves — DEVICE
    This intervention includes sleeves absent of semiconductors that will be worn for 4 months post-operatively.

Study Details

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

Key Dates

Start date
Sep 11, 2024
Status verified
May 2025
Primary completion
May 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
135 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control Group
    This arm of the study involves the control group who will receive the standard of care.
  • Active Comparator: Semiconducting Fabric Sleeve Group
    This group will be receiving semiconducting fabric sleeve to be worn post-operatively.
  • Placebo Comparator: Placebo Group
    This group receives a look-alike sleeve that contains no semiconductor material.

Primary Outcome Measure

Range of motion [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Illinois Bone and Joint InstituteWestmontIllinois60559

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By research site
Illinois Bone and Joint Institute· Westmont, IL

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