Incrediwear ACL MCL Arthroscopic Surgery Recovery Study
NCT ID: NCT06240780
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
90 participants
INTERVENTIONAL
2024-08-30
2026-12-31
Brief Summary
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* 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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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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.
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.
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.
Sham Incrediwear Products
Simple fabric Incrediwear products that do not include the semiconductor elements within the fabric.
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.
No interventions assigned to this group
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.
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.
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.
Sham Incrediwear Products
Simple fabric Incrediwear products that do not include the semiconductor elements within the fabric.
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.
No interventions assigned to this group
Interventions
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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.
Sham Incrediwear Products
Simple fabric Incrediwear products that do not include the semiconductor elements within the fabric.
Eligibility Criteria
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Inclusion Criteria
* Compliant to protocol
* BMI less than 35
* Undergoing ACL or ACL+MCL within 30 days
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Oklahoma Joint Reconstruction Institute
OTHER
Responsible Party
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Principal Investigators
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Garrett Steinmetz, MD
Role: PRINCIPAL_INVESTIGATOR
Oklahoma Joint Reconstruction Institute
Locations
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Oklahoma Joint Reconstruction Institute
Oklahoma City, Oklahoma, United States
Countries
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Related Links
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Current and past research information regarding the Incrediwear products.
Other Identifiers
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2023-04
Identifier Type: -
Identifier Source: org_study_id
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