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ENROLLING BY INVITATION
NCT06240780
NA

Incrediwear ACL MCL Arthroscopic Surgery Recovery Study

Sponsor: Oklahoma Joint Reconstruction Institute

View on ClinicalTrials.gov

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

Official title: A Randomized Prospective Study to Evaluate the Incrediwear Products Immediately After ACL or ACL+MCL Arthroscopic Surgery

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2024-08-30

Completion Date

2026-12-31

Last Updated

2025-09-30

Healthy Volunteers

Yes

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.

Locations (1)

Oklahoma Joint Reconstruction Institute

Oklahoma City, Oklahoma, United States