Incrediwear Products for ACL Surgery Recovery

Overseen By Gina Myer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oklahoma Joint Reconstruction Institute

Disqualifiers: Rheumatoid arthritis, Diabetes, Blood clots, others

Compensation: Varies

Number of Visits: 45

90 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Garrett Steinmetz, MD

Principal Investigator

Oklahoma Joint Reconstruction Institute

Eligibility Criteria

This trial is for healthy men and women aged 18 to 65 who are undergoing ACL or ACL+MCL arthroscopic surgery. Participants will use Incrediwear knee products post-surgery and document their pain, swelling, and range of motion.

Inclusion Criteria

Consented to protocol

I am scheduled for ACL or ACL and MCL surgery within the next 30 days.

Compliant to protocol

Exclusion Criteria

Worker's Comp patients

I have had blood clots in the past.

Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Recovery

Participants undergo ACL or ACL+MCL arthroscopic surgery and begin initial recovery with Incrediwear products

4 weeks

Postop Day 0, Day 3, Day 7, Day 14, Day 21, Day 30

Extended Recovery

Participants continue recovery with modified use of Incrediwear products

5 months

Day 45, Day 60, Day 100, Day 180

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Incrediwear Products

Trial Overview The study tests if Incrediwear knee products can reduce pain and swelling while improving joint movement after surgery compared to a placebo. Ninety patients will be divided into six groups, with assignments made randomly and kept secret from both the patients and researchers.

Participant Groups

Group I: ACL Arthroscopic Active Participants Active Control 1 Intervention

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.

Group II: ACL Arthroscopic Stand of Care Participants Active Control 1 Intervention

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

Group III: ACL + MCL Arthroscopic Active Participants Active Control 1 Intervention

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.

Group IV: ACL + MCL Arthroscopic Stand of Care Participants Active Control 1 Intervention

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

Group V: ACL Arthroscopic Placebo Participants Placebo Group 1 Intervention

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.

Group VI: ACL + MCL Arthroscopic Placebo Participants Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Oklahoma Joint Reconstruction Institute

Lead Sponsor

Trials

1

Recruited

90+