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

NCT06979804 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2025-05-22

No results posted yet for this study

Summary

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

Conditions

  • ACL Reconstruction
  • Meniscus Tears
  • Anterior Cruciate Ligament Rupture

Interventions

DEVICE

Semiconducting fabric sleeves

This intervention includes semiconductor embedded sleeves that patients will wear for 4 months post-operatively.

DEVICE

Non-semiconducting fabric sleeves

This intervention includes sleeves absent of semiconductors that will be worn for 4 months post-operatively.

Sponsors & Collaborators

  • INCREDIWEAR HOLDINGS, INC.

    collaborator INDUSTRY

  • Illinois Center for Orthopaedic Research and Education

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-11
Primary Completion
2026-05-01
Completion
2026-10-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06979804 on ClinicalTrials.gov