Incrediwear ACL MCL Arthroscopic Surgery Recovery Study

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
Oklahoma Joint Reconstruction Institute
Study ID
NCT06240780
Status
Enrolling By Invitation

Conditions

  • Anterior Cruciate Ligament Reconstruction
  • Arthroscopic Surgical Procedures

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Activated Incrediwear Products — OTHER
    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 — OTHER
    Simple fabric Incrediwear products that do not include the semiconductor elements within the fabric.

Study Details

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

Key Dates

Start date
Aug 30, 2024
Status verified
Sep 2025
Primary completion
Aug 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Subjective Patient Pain Experience [ Time Frame: 180 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Oklahoma Joint Reconstruction InstituteOklahoma CityOklahoma73114-

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