Incrediwear Leg Sleeve for Anterior Cruciate Ligament Injury
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.12345Why 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.23567
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Immediate Postoperative Recovery
Participants undergo ACL or ACL+MCL arthroscopic surgery and begin immediate postoperative recovery with assigned products
Postoperative Monitoring
Participants are monitored for pain, range of motion, and knee effusion with regular assessments
Follow-up
Participants are monitored for long-term safety and effectiveness after the main postoperative period
What Are the Treatments Tested in This Trial?
Interventions
- Incrediwear Products
Find a Clinic Near You
Who Is Running the Clinical Trial?
Texas Bone and Joint
Lead Sponsor
INCREDIWEAR HOLDINGS, INC.
Industry Sponsor
Medical City Denton
Collaborator