Incrediwear ACL MCL Arthroscopic Surgery Recovery Study

Anterior Cruciate Ligament Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06240780
• Other study ID #: 2023-04
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Oklahoma Joint Reconstruction Institute
• Contact: Elaine Justice, RN
• Phone: 405-419-5423
• Email: elaine[@]drpauljacob.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 31, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction

Intervention

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

Locations

Country	Name	City	State
United States	Oklahoma Joint Reconstruction Institute	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Oklahoma Joint Reconstruction Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Pain Medication Usage	Patient will document pain medication type and quantity taken in a daily pain diary.	180 days
Primary	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
Primary	Range of Motion	The patient's range of motion captured at all time points during the postoperative period.	180 days

External Links

•   Current and past research information regarding the Incrediwear products.