Incrediwear ACL MCL Arthroscopic Surgery Recovery Study

Oklahoma Joint Reconstruction Institute

Status

Invitation-only

Conditions

Anterior Cruciate Ligament Reconstruction

Arthroscopic Surgical Procedures

Treatments

Other: Sham Incrediwear Products

Other: Activated Incrediwear Products

Study type

Interventional

Funder types

Other

Identifiers

NCT06240780

2023-04

Details and patient eligibility

About

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

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

90 participants in 6 patient groups, including a placebo group

ACL Arthroscopic Active Participants

Active Comparator group

Description:

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.

Treatment:

Other: Activated Incrediwear Products

ACL Arthroscopic Placebo Participants

Placebo Comparator group

Description:

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.

Treatment:

Other: Sham Incrediwear Products

ACL Arthroscopic Stand of Care Participants

No Intervention group

Description:

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 group

Description:

Treatment:

Other: Activated Incrediwear Products

ACL + MCL Arthroscopic Placebo Participants