Clinical trial NCT06240780: Incrediwear ACL MCL Arthroscopic Surgery Recovery Study
Official title: A Randomized Prospective Study to Evaluate the Incrediwear Products Immediately After ACL or ACL+MCL Arthroscopic Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Arthroscopic Surgical Procedures
Anterior Cruciate Ligament Reconstruction
Keywords: Arthroscopic Surgical Procedures
Anterior Cruciate Ligament Reconstruction
Medial Collateral Ligament Reconstruction
Lead sponsor: Oklahoma Joint Reconstruction Institute
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: . 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.
Primary purpose: SUPPORTIVE_CARE

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Subjective Patient Pain Experience
timeFrame: 180 days
measure: Pain Medication Usage
timeFrame: 180 days
measure: Effusion/swelling Measurements
timeFrame: 180 days
measure: Range of Motion
timeFrame: 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma Joint Reconstruction Institute
state: Oklahoma
Study officials:
affiliation: Oklahoma Joint Reconstruction Institute
name: Garrett Steinmetz, MD
role: PRINCIPAL_INVESTIGATOR
References: