Incrediwear ACL MCL Arthroscopic Surgery Recovery Study

NCT06240780 | Enrolling By Invitation

• 1 other identifier: 2023-04
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Arthroscopic Surgical Procedures; Anterior Cruciate Ligament Reconstruction; Medial Collateral Ligament Reconstruction

Outcome Measures

Primary Outcomes (4)

• Subjective Patient Pain Experience

  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

• Pain Medication Usage

  Patient will document pain medication type and quantity taken in a daily pain diary.

  180 days

• Effusion/swelling Measurements

  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

• Range of Motion

  The patient's range of motion captured at all time points during the postoperative period.

  180 days

Study Arms (6)

ACL Arthroscopic Active Participants

ACTIVE COMPARATOR

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

ACL Arthroscopic Placebo Participants

PLACEBO COMPARATOR

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

ACL Arthroscopic Stand of Care Participants

NO INTERVENTION

After the surgery, the patient will be placed in thigh high compression hose, bilaterally, worn 23 hours per day for 31 days.

ACL + MCL Arthroscopic Active Participants

ACTIVE COMPARATOR

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

ACL + MCL Arthroscopic Placebo Participants

PLACEBO COMPARATOR

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

ACL + MCL Arthroscopic Stand of Care Participants

NO INTERVENTION

After the surgery, the patient will be placed in thigh high compression hose, bilaterally, worn 23 hours per day for 31 days.

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.

ACL + MCL Arthroscopic Active Participants; ACL Arthroscopic Active Participants

Sham Incrediwear Products OTHER

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

ACL + MCL Arthroscopic Placebo Participants; ACL Arthroscopic Placebo Participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oklahoma Joint Reconstruction Institute: lead

Study Sites (1)

Oklahoma Joint Reconstruction Institute

Oklahoma City, Oklahoma, 73114, United States

Location

Related Links

• Current and past research information regarding the Incrediwear products.

Study Officials

• Garrett Steinmetz, MD

  Oklahoma Joint Reconstruction Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double blinded stratified randomization of subjects from two arms into one of three groups per arm.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: . Participants will randomly be assigned treatment type in addition to the standard of care procedure they will be instructed to follow (active vs. placebo vs standard of care alone) based on surgery type. An equal number of patients from each primary condition type (ACL or ACL+MCL) will be assigned to each treatment type.

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 5, 2024
• Study Start: August 30, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available at the conclusion of the study, and may be used for publication approximately 6 months after study closes.
• Access Criteria: Access to study protocol, SAP,ICF, CSR, and analytic code will be available upon request to the PRS.

Locations

US (1)