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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether Incrediwear knee products aid recovery after ACL or ACL+MCL knee surgeries. The primary goal is to determine if these products reduce pain and swelling and improve movement more quickly than not using them. Participants will experience different approaches, including Incrediwear products, a placebo, or standard care. Ideal candidates are those who have undergone ACL or ACL+MCL surgery within the last 30 days and are in generally good health. As an unphased trial, this study allows participants to contribute to innovative research that could enhance recovery options for future patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Incrediwear products are safe for postoperative recovery?

Research shows that Incrediwear products are generally well-tolerated by users. Past studies have demonstrated that these products aid recovery from surgeries such as ACL (a knee ligament) and ACL+MCL (another knee ligament) repairs. No major reports of serious side effects have emerged from using Incrediwear, suggesting that these products are safe for most people. However, as with any treatment, individual experiences may vary, and participants should report any discomfort or reactions while using them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Incrediwear products for ACL surgery recovery because they feature a unique semiconductor element woven into the fabric. This technology is designed to enhance blood flow and reduce inflammation, potentially speeding up recovery times compared to standard compression hoses. Unlike traditional methods that focus solely on compression, Incrediwear aims to actively stimulate the body's natural healing processes, offering a promising alternative for patients looking to recover more efficiently.

What evidence suggests that Incrediwear products are effective for ACL surgery recovery?

Research has shown that Incrediwear products might help reduce pain and swelling after surgeries on the ACL (anterior cruciate ligament) and ACL+MCL (medial collateral ligament). In this trial, some participants will use the semiconductor element interwoven Incrediwear Leg Sleeve and Incrediwear Knee Sleeve. These products are designed to enhance joint movement and speed up recovery by improving blood flow and reducing swelling. Early results suggest these products can lead to quicker improvements in knee mobility. While more research is needed, early signs are promising for those seeking faster recovery after surgery. ^{1 2 3 6 7}

Who Is on the Research Team?

Garrett Steinmetz, MD

Principal Investigator

Oklahoma Joint Reconstruction Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06240780

Incrediwear ACL MCL Arthroscopic Surgery Recovery Study The goal of this clinical trial is to assess the benefits of using the Incrediwear knee products after anterior cruciate ligament arthroscopic surgery or ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06668376

A Study to Evaluate the Incrediwear Products Immediately ... To assess the benefits of using the Incrediwear knee products after ACL or ACL+MCL arthroscopic surgery, on the postoperative pain, range of motion and effusion ...

3. withpower.com withpower.com/trial/phase-anterior-cruciate-ligament-reconstruction-1-2024-7dfc6

Incrediwear Products for ACL Surgery Recovery Trial Overview The study tests if Incrediwear knee products can reduce pain and swelling while improving joint movement after surgery compared to a placebo.

4. orthout.com orthout.com/blogs/news/incrediwear-knee-sleeve-study?srsltid=AfmBOor4NoDN8_eXuoGHH_0NWY-7dh1jzuxq6d6j3aZ0BU6HgrrQgsgJ

Incrediwear Knee Sleeve Boosts Recovery The Incrediwear Knee Sleeve is a garment designed to help boost recovery and relieve pain after joint injuries and surgical procedures.

5. ctv.veeva.com ctv.veeva.com/study/a-randomized-prospective-study-to-evaluate-the-incrediwear-products-immediately-after-acl-repair

A Study to Evaluate the Incrediwear Products Immediately ... To assess the benefits of using the Incrediwear knee products after ACL or ACL+MCL arthroscopic surgery, on the postoperative pain, range of ...

6. incrediwear.com incrediwear.com/pages/research?srsltid=AfmBOoqBOJjRuuJI7UYuuWPfzuL_Fl13HGl1jHBxOHt7JVc3kWnkMwdC

Research Investigation of the effects of wearing Incrediwear products for improved recovery and reduction in player downtime.

7. incrediwear.com incrediwear.com/blogs/news/football-injuries?srsltid=AfmBOoq_aOLlJ1IQ_qv3a7YZ-TAP08Adi-tciP-Rw8wR39BG2m2CJPFf

6 Common Football Injuries & How To Recover They focus on strengthening, flexibility, and proprioception exercises, aiding recovery from ligament injuries such as ACL tears and ankle ...