NCT06668376

A Study to Evaluate the Incrediwear Products Immediately After ACL Repair

Enrolling by Invitation
NAAges 18–65InterventionalTreatment
Texas Bone and Joint
~90 participants
Updated 2024-11-01 on ClinicalTrials.gov
What's tested:Leg SleevePlacebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Visual Analogue Scale
Measured over 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)
+1 more outcome measured
Anterior Cruciate Ligament Tear
Medial Collateral Ligament
1 sites across 1 states
Texas1
  • Christopher Flowers, MD, MS · PRINCIPAL_INVESTIGATOR · Texas Bone and Joint

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Visual Analogue ScalePreop 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.

  • Range of Motion Measured by a GoniometerPreop 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.