Clinical trial NCT06668376: A Study to Evaluate the Incrediwear Products Immediately After ACL Repair
Official title: A Study to Evaluate the Incrediwear Products Immediately After ACL or ACL+MCL Arthroscopic Surgery
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
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
Lead sponsor: Texas Bone and Joint
Sponsor class: OTHER
Collaborators: name: INCREDIWEAR HOLDINGS, INC.
name: Medical City Denton
First posted: 2024-10-31
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized Prospective Study
Primary purpose: TREATMENT

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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 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)
measure: Range of Motion Measured by a Goniometer
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Denton
country: United States
facility: Medical City Denton
state: Texas
Study officials:
affiliation: Texas Bone and Joint
name: Christopher Flowers, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: