Incrediwear Leg Sleeve for Anterior Cruciate Ligament Injury

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Texas Bone and Joint

Disqualifiers: Pregnancy, Rheumatoid arthritis, Diabetes, others

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the benefits of using Incrediwear knee sleeves after ACL or ACL+MCL surgery. The goal is to determine if these sleeves reduce pain, improve movement, and decrease swelling in the months following surgery. Participants will be divided into groups to use either the Incrediwear sleeves, placebo sleeves, or follow standard care with compression hose. Individuals who have undergone ACL or ACL+MCL surgery within the last 30 days and meet specific health criteria, such as having a BMI under 35, may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to understanding innovative recovery options after knee surgery.

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 study team or your doctor.

What prior data suggests that the Incrediwear leg sleeve is safe for postoperative use?

Research shows that Incrediwear products provide support and protection for mild to moderate ACL (anterior cruciate ligament) and knee injuries. Although specific safety data from earlier studies on these products is limited, the widespread use of knee sleeves suggests they are generally safe for most users.

Incrediwear knee sleeves aim to aid recovery after surgery by reducing pain and improving mobility. Studies on similar products indicate that knee sleeves can enhance knee movement during activities like jumping, suggesting they can be beneficial with minimal risk.

This trial does not have a specific phase, so the safety information may not be as detailed as in later trials. However, knee sleeves are commonly used for similar issues and typically have a good safety record, providing some reassurance about their safety for this study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Incrediwear Leg Sleeve for ACL injuries because it introduces a unique approach compared to traditional treatments like physical therapy and surgery. Unlike other treatments that primarily focus on structural repair and rehabilitation, the Incrediwear Leg Sleeve utilizes fabric technology designed to increase blood flow and reduce inflammation. This non-invasive option offers potential for faster recovery and less reliance on medication, appealing to both clinicians and patients looking for innovative, less burdensome recovery methods.

What evidence suggests that the Incrediwear leg sleeve is effective for ACL injuries?

Research has shown that Incrediwear leg sleeves may aid recovery after ACL (anterior cruciate ligament) surgery. In this trial, participants will join different treatment arms, including one with the Incrediwear product and another with a placebo. Studies have found that these sleeves can reduce pain and swelling compared to not using them. Another study found that wearing knee sleeves improved knee movement during exercises. People recovering from knee surgeries, such as ACL or knee replacement, have reported better outcomes. These findings suggest that Incrediwear products could effectively support recovery and enhance comfort after surgery. ^{2 3 5 6 7}

Who Is on the Research Team?

Christopher Flowers, MD, MS

Principal Investigator

Texas Bone and Joint

Are You a Good Fit for This Trial?

This trial is for individuals who have recently undergone ACL or ACL+MCL surgery. Participants should be in the initial six months of their postoperative period. Specific eligibility criteria are not provided, but typically include factors like age, overall health, and the specifics of their injury and surgery.

Inclusion Criteria

Consented to protocol

Compliant protocol

BMI less than 35

Exclusion Criteria

Pregnancy

Worker's Comp patients

Pain management patient

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Surgery and Immediate Postoperative Recovery

Participants undergo ACL or ACL+MCL arthroscopic surgery and begin immediate postoperative recovery with assigned products

1 week

Daily monitoring (in-person)

Postoperative Monitoring

Participants are monitored for pain, range of motion, and knee effusion with regular assessments

6 months

Visits on Postop Day 0, Day 3, Day 7, Day 14, Day 21, Day 30, Day 45, Day 60, Day 100, and Day 180

Follow-up

Participants are monitored for long-term safety and effectiveness after the main postoperative period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Incrediwear Products

Trial Overview

The study is testing Incrediwear knee products to see if they help with pain, swelling, and range of motion after ACL or MCL surgeries compared to placebo products or no compression at all over a six-month period.

How Is the Trial Designed?

Group I: Incrediwear Product Active Control 1 Intervention

Once the informed consent has occurred, the patient will be invited to enroll in the study. The patient will be shown the Incrediwear products and given instructions. 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. The study will be double blinded as to the active vs placebo groups.

Group II: Placebo Product Placebo Group 1 Intervention

Once the informed consent has occurred, the patient will be invited to enroll in the study. The patient will be shown the Incrediwear products and given instructions. 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. The study will be double blinded as to the active vs placebo groups.

Who Is Running the Clinical Trial?

Texas Bone and Joint

Lead Sponsor

Trials

2

Recruited

230+

INCREDIWEAR HOLDINGS, INC.

Industry Sponsor

Trials

6

Recruited

630+

Medical City Denton

Collaborator

Trials

2

Recruited

230+

Published Research Related to This Trial

A study of 248 patient injury claims related to ACL reconstruction in Finland revealed that the most common complications leading to compensation were deep surgical site infections (DSSI) and malposition of the graft tunnel, particularly on the femoral side.

Improving surgical techniques and focusing on infection prevention could significantly reduce the occurrence of serious complications following ACL reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterior cruciate ligament reconstruction-related patient injuries: a nationwide registry study in Finland. Nyrhinen, KM., Bister, V., Helkamaa, T., et al.[2020]

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 ...

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.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9186011/

Immediate and six-week effects of wearing a knee sleeve ...

Application of knee sleeves following ACLR is associated with improved knee flexion angles during hop landing training.

5.

incrediwear.com

incrediwear.com/blogs/news/knee-surgery-heres-how-to-recover?srsltid=AfmBOoruXzJrpQ6dr3hxQFz5RDvc6arOIwtPKdKzizwABfUjDtNJYtzh

Knee Surgery? Here's How to Recover

Yes, our products are safe and effective after knee replacement surgery. We have just completed a TKR study with amazing results which will be ...

6.

incrediwear.com

incrediwear.com/collections/acl-and-knee-injuries?srsltid=AfmBOoomWWebkQdmARwjyamBK0_SEeIdT9gu1BwX4C4KuF5iBTHQTFaV

Sleeves for ACL & Knee injuries

Incrediwear Knee Sleeves · Provides excellent stability, protection and compression · Designed for mild to moderate ACL & Knee injuries. Buy now.

7.

incrediwear.com

incrediwear.com/blogs/news/football-injuries?srsltid=AfmBOoqXlewrEVdB55dvhx4HsJgh8V6c-g5PMRpTjdnz5aGy55Ht4YYi

6 Common Football Injuries & How To Recover

Let's look at six common football injuries and how to prevent and recover from them to get you back on the field and playing again.