Incrediwear ACL MCL Arthroscopic Surgery Recovery Study

September 24, 2025 updated by: Oklahoma Joint Reconstruction Institute

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

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Researcher will identify patients of the Primary Investigator (PI) who are candidate for the study. Subjects must otherwise be in good health as determined by medical history, physical examination, vital signs, and applicable laboratory tests and receive medical clearance for the procedure by the PI.

Subjects must be able to read and sign an informed consent form indicating understand the purpose of, and the procedures required for the study, and are willing to participate and comply with the study protocol.

This will be a prospective study to evaluate the benefit of the Incrediwear product after ACL repair or ACL+MCL repair via arthroscopic surgery. Subjects who fit the inclusion and exclusion criteria will be reviewed on a subject-by-subject basis at the time of informed consent documentation.

Preoperative and Post-Operative Measurements:

Subjective: Participants rates surgical site pain, on a 0-10 Visual Analogue Scale (VAS) pain scale.

Participants will record pain medication type and quantity taken in a daily pain diary.

Objective: Surgical extremity range of motion, and surgical extremity knee effusion.

Measurements will be taken at; Preop appointment, Postop Day 0, Day 3, Day 7, Day 14, Day 21, Day 30 (1 month), Day 45, Day 60 (2 month), Day 100 (3 month), and Day 180 (6 month).

After the surgery, the participant will be placed in the study provided Incrediwear Leg Sleeve from the ankle to the thigh and the Incrediwear sock. The Participant will wear the products at all times, for a minimum of 23 hours per day, for days 1 through 30.

At day 31, the participant will wear the leg sleeve at night, knee sleeve during the day, and is no longer required to wear the Incrediwear sock, until day 180.

At the 6 month postoperative appointment, the participant will turn in the patient journal.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73114
        • Oklahoma Joint Reconstruction Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Consented to protocol
  • Compliant to protocol
  • BMI less than 35
  • Undergoing ACL or ACL+MCL within 30 days

Exclusion Criteria:

  • Rheumatoid Arthritis
  • Poorly controlled diabetes (HgA1c > 7.5)
  • Previous blood clots
  • BMI greater than 35
  • Varicosities on operative leg
  • Pain management patient
  • Prior knee surgery to the operative / study knee
  • Worker's Comp patients
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ACL Arthroscopic Active Participants
After the surgery, the patient will be placed in the study provided semiconductor element interwoven Incrediwear Leg Sleeve from the ankle to the thigh and the Incrediwear sock, on the operative leg, and a thigh high compression hose on the non operative leg, worn 23 hours per day. At day 31 patient will wear the leg sleeve at night and be placed in the Incrediwear Knee Sleeve.
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.
Placebo Comparator: ACL Arthroscopic Placebo Participants
After the surgery, the patient will be placed in the study provided plain fabric Incrediwear Leg Sleeve from the ankle to the thigh and the Incrediwear sock, on the operative leg, and a thigh high compression hose on the non operative leg, worn 23 hours per day. At day 31 patient will wear the leg sleeve at night and be placed in the Incrediwear Knee Sleeve.
Other: Sham Incrediwear Products
Simple fabric Incrediwear products that do not include the semiconductor elements within the fabric.
No Intervention: ACL Arthroscopic Stand of Care Participants
After the surgery, the patient will be placed in thigh high compression hose, bilaterally, worn 23 hours per day for 31 days.
Active Comparator: ACL + MCL Arthroscopic Active Participants
After the surgery, the patient will be placed in the study provided semiconductor element interwoven Incrediwear Leg Sleeve from the ankle to the thigh and the Incrediwear sock, on the operative leg, and a thigh high compression hose on the non operative leg, worn 23 hours per day. At day 31 patient will wear the leg sleeve at night and be placed in the Incrediwear Knee Sleeve.
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.
Placebo Comparator: ACL + MCL Arthroscopic Placebo Participants
After the surgery, the patient will be placed in the study provided plain fabric Incrediwear Leg Sleeve from the ankle to the thigh and the Incrediwear sock, on the operative leg, and a thigh high compression hose on the non operative leg, worn 23 hours per day. At day 31 patient will wear the leg sleeve at night and be placed in the Incrediwear Knee Sleeve.
Other: Sham Incrediwear Products
Simple fabric Incrediwear products that do not include the semiconductor elements within the fabric.
No Intervention: ACL + MCL Arthroscopic Stand of Care Participants
After the surgery, the patient will be placed in thigh high compression hose, bilaterally, worn 23 hours per day for 31 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Medication Usage
Time Frame: 180 days
Patient will document pain medication type and quantity taken in a daily pain diary.
180 days
Range of Motion
Time Frame: 180 days
The patient's range of motion captured at all time points during the postoperative period.
180 days
Subjective Patient Pain Experience
Time Frame: 180 days
The Visual Analogue Scale (VAS), a 0 to 10 scale, with 0 being no pain and 10 being the worst pain will be used to measures pain intensity.
180 days
Effusion/swelling Measurements
Time Frame: 180 days
The Patella sweep test is used to measure effusion. The measured rating is a quantity on a scale of 0 to 3, with 0 rating no fluid-wave while perorming a downward stroke, 1 a large bulge, 2 medial fluid returns to position without performing a downward sweep, and 3 excell of fluid that makes it impossible to stroke the medial fluid away. Measurements will be taken at set times during the postoperative period.
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oklahoma Joint Reconstruction Institute

Investigators

  • Principal Investigator: Garrett Steinmetz, MD, Oklahoma Joint Reconstruction Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2024

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 26, 2024

First Submitted That Met QC Criteria

January 26, 2024

First Posted (Actual)

February 5, 2024

Study Record Updates

Last Update Posted (Estimated)

September 30, 2025

Last Update Submitted That Met QC Criteria

September 24, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication.

IPD Sharing Time Frame

Data will become available at the conclusion of the study, and may be used for publication approximately 6 months after study closes.

IPD Sharing Access Criteria

Access to study protocol, SAP,ICF, CSR, and analytic code will be available upon request to the PRS.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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