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Enrolling by Invitation

NCT Number: NCT06668376

A Study to Evaluate the Incrediwear Products Immediately After ACL Repair

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.

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Key information

Conditions

Anterior Cruciate Ligament Tear Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Medial Collateral Ligament Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical City Denton

Denton, Texas, 76210, United States

About this study

After knee surgery, the participant will be randomly assigned to one of the three groups. The participant will have a 1-in-3 chance of being assigned to each group. The products will be placed on the participant by the hospital staff according to the random assignment sent with the surgical packet.

Study Screening/pre-operative appointment

  • The surgeon confirms the participant meets the inclusion criteria and are scheduled for surgery in the next few weeks, and how the participant may be eligible to participate in the study.
  • The surgeon will discuss the study and possible risks/benefits of being in the research.
  • Day of surgery
  • The study packet will be sent to the hospital by the clinical staff. The packet will include a study number assignment, the products assigned the study number, and the patient study journal. The participant, surgeon, and hospital staff will not know which group the participant are in, with the exception of the standard of care control group, as this group will wear the hospital-issued compression hose.
  • Postoperative Recovery
  • Subjective: Patient rates surgical site pain, on a 0-10 VAS pain scale. Patients will record pain medication type and quantity taken in a daily pain diary.
  • Objective: Surgical extremity range of motion, and surgical extremity knee effusion, measured by either the Physical Therapist or the surgeon at the postop appointment.
  • Measurements will be taken at; 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Visual Analogue Scale

    Time frame: 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)

    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.

  2. Range of Motion Measured by a Goniometer

    Time frame: 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)

    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.

Sponsors and collaborators

Lead sponsor

Texas Bone and Joint

Other

Collaborators

  • INCREDIWEAR HOLDINGS, INC.
  • Medical City Denton

Registry information

Official study title

A Study to Evaluate the Incrediwear Products Immediately After ACL or ACL+MCL Arthroscopic Surgery

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 31, 2024
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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