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Incrediwear ACL MCL Arthroscopic Surgery Recovery Study

NCT06240780 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-09-30

No results posted yet for this study

Summary

The goal of this clinical trial is to assess the benefits of using the Incrediwear knee products after anterior cruciate ligament arthroscopic surgery or anterior cruciate ligament and medial collateral ligament (ACL+MCL) arthroscopic surgery, on the postoperative pain, range of motion and effusion. Participant population includes female or male patients in relative good health, 18 to 65 years old. The investigators will compare participants with Incrediwear and placebo Incrediwear products during the first 6-month postoperative period. The main question it aims to answer are:

* Will the Incrediwear products help participants to decrease postoperative pain and swelling?
* Will the Incrediwear products help the participants by increasing the range of motion in a shorter amount of time than the placebo group? Participants will be asked to maintain a journal documenting surgical site pain, pain medication type and quantity taken.

Researcher will compare 90 participants enrolled in one of six groups, double blinded and randomly assigned, to see if the Incrediwear products assist in controlling postoperative swelling, and increase range of motion in a shorter amount of time.

* ACL participants randomly assigned the Incrediwear product, placebo product, or none
* ACL+MCL participants randomly assigned the Incrediwear product, placebo product, or none

Conditions

  • Arthroscopic Surgical Procedures
  • Anterior Cruciate Ligament Reconstruction

Interventions

OTHER

Activated Incrediwear Products

Activated Incrediwear products incorporates semiconductor elements within the fabric that releases negative ions when stimulated by body heat. The negative ions activate cellular vibrations that increase blood flow and circulation.

OTHER

Sham Incrediwear Products

Simple fabric Incrediwear products that do not include the semiconductor elements within the fabric.

Sponsors & Collaborators

  • Oklahoma Joint Reconstruction Institute

    lead OTHER

Principal Investigators

  • Garrett Steinmetz, MD · Oklahoma Joint Reconstruction Institute

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-30
Primary Completion
2026-08-30
Completion
2026-12-31

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 NCT06240780 on ClinicalTrials.gov