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

90 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Incrediwear Leg Sleeve for Anterior Cruciate Ligament Injury?

Research suggests that wearing knee sleeves can be helpful in rehabilitation after ACL surgery, as they may improve stability and function. While specific data on Incrediwear Leg Sleeves is not provided, similar products have shown benefits in supporting knee recovery. ^{1 2 3 4 5}

Is the Incrediwear Leg Sleeve generally safe for humans?

There is no specific safety data available for the Incrediwear Leg Sleeve, but a case of allergic contact dermatitis (skin reaction) was reported with a different knee brace, which resolved with treatment. This suggests that while generally safe, some individuals may experience skin reactions to similar products. ^{3 6 7 8 9}

How does the Incrediwear Leg Sleeve treatment differ from other treatments for ACL injuries?

The Incrediwear Leg Sleeve is unique because it is a wearable sleeve that may aid in rehabilitation by providing support and potentially improving function after an ACL injury, unlike traditional treatments that primarily focus on exercise programs. While knee sleeves are commonly used, the Incrediwear Leg Sleeve may offer additional benefits through its specific design and materials, which are not detailed in the available research. ^{1 2 3 5 10}

What is the purpose of this trial?

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. The study team will compare patients with Incrediwear products, or placebo Incrediwear products, or no products during the first 6-month postoperative period. The group that does not wear the Incrediwear or placebo products is considered the standard of care control group and will proceed with the normal standard of care compression hose.

Research Team

Christopher Flowers, MD, MS

Principal Investigator

Texas Bone and Joint

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

"Custom-fit" versus "off-the-shelf" ACL functional braces. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Immediate and 6-week effects of wearing a knee sleeve following anterior cruciate ligament reconstruction: a cross-over laboratory and randomised clinical trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Quadriceps function after exercise in patients with anterior cruciate ligament-reconstructed knees wearing knee braces. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The effects of "decelerated" rehabilitation following anterior cruciate ligament reconstruction on a hyperelastic female adolescent: a case study. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Immediate and six-week effects of wearing a knee sleeve following anterior cruciate ligament reconstruction on knee kinematics and kinetics: a cross-over laboratory and randomised clinical trial. [2022]

6. Sweden pubmed.ncbi.nlm.nih.gov

Anterior cruciate ligament reconstruction-related patient injuries: a nationwide registry study in Finland. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Localized erythema multiforme-like contact dermatitis from a knee brace. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Risk Factors for Anterior Cruciate Ligament Injury in Competitive Adolescent Alpine Skiers. [2022]

9. Italy pubmed.ncbi.nlm.nih.gov

Anterior cruciate ligament injury risk factors in football. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

[The influence of knee bandages on sport specific capabilities in healthy volunteers and patients with rupture of the anterior cruciate ligament]. [2016]