A Study to Evaluate the Incrediwear Products Immediately After ACL Repair

NCT06668376 | Enrolling By Invitation FDA Device

• 1 other identifier: IRBNet 2205451-2
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anterior Cruciate Ligament Tear; Medial Collateral Ligament

Keywords

Anterior Cruciate Ligament Tear; Medial Collateral Ligament Tear; Anterior Cruciate Ligament Repair; Medial Collateral Ligament Repair; Arthroscopic surgery

Outcome Measures

Primary Outcomes (2)

• Visual Analogue Scale

  The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. The minimum number is zero meaning no pain and maximum number is 10 meaning the most pain the patient has every felt in their entire life. Lower scores are ideal while higher scores are indicative of the patient in a lot of pain.

  Preop appointment, Postop Day 0, Day 3, Day 7, Day 14, Day 21, Day 30 (1 month), Day 45, Day 60 (2 month), Day 100 (3 month), and Day 180 (6 month)

• Range of Motion Measured by a Goniometer

  Knee flexion and extension to assess mobility and functionality of the knee joint. The knee joint's range of motion (ROM) is an important clinical parameter used in knee assessment. Knee flexion should be about 150 degrees and knee extension should be about zero degrees (American Medical Association). Lower degrees of flexion are not ideal while higher degrees of extension are not optimal.

  Preop appointment, Postop Day 0, Day 3, Day 7, Day 14, Day 21, Day 30 (1 month), Day 45, Day 60 (2 month), Day 100 (3 month), and Day 180 (6 month)

Study Arms (2)

Placebo Product

PLACEBO COMPARATOR

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.

Device: Placebo

Incrediwear Product

ACTIVE COMPARATOR

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.

Device: Leg Sleeve

Interventions

Leg Sleeve DEVICE

Once the informed consent has occurred, the patient will be invited to enroll in the study. The patient will be shown the Incrediwear product (Leg Sleeve) 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.

Incrediwear Product

Placebo DEVICE

Once the informed consent has occurred, the patient will be invited to enroll in the study. The patient will be shown the Incrediwear product (Leg Sleeve) 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.

Placebo Product

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consented to protocol
• Compliant protocol
• BMI less than 35
• Undergoing ACL or ACL+MCL within 30 days

You may not qualify if:

• Pregnancy
• Rheumatoid Arthritis
• Poorly controlled diabetes (HgA1c \> 7.5)
• Previous blood clots
• BMI greater than 35
• Varicosities on operative leg
• Pain management patient
• Prior knee surgery to the operative / study knee
• Worker's Comp patients

Sponsors & Collaborators

• Texas Bone and Joint: lead
• INCREDIWEAR HOLDINGS, INC.: collaborator
• Medical City Denton: collaborator

Study Sites (1)

Medical City Denton

Denton, Texas, 76210, United States

Location

Related Links

• Leg Sleeve

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Christopher Flowers, MD, MS

  Texas Bone and Joint

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon

Model Details: A Randomized Prospective Study

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: October 31, 2024
• Study Start: October 29, 2024
• Primary Completion (Estimated): October 29, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

US (1)