Clinical Outcomes Related to Arthroscopic Rotator Cuff Repair Recovery Using Incrediwear

NCT06669741 | Enrolling By Invitation FDA Device

• 1 other identifier: IRBNet 2246455-1
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the benefits of using the Incrediwear products for patients recovering from Arthroscopic Rotator Cuff Repair surgery for postoperative pain, range of motion, and swelling.

Conditions

Rotator Cuff Tears; Rotator Cuff Injuries; Rotator Cuff Arthropathy of Left Shoulder (Disorder); Rotator Cuff Arthropathy of Right Shoulder (Disorder); Rotator Cuff Arthropathy of Bilateral Shoulders

Outcome Measures

Primary Outcomes (1)

• Arm Circumference Measure with a Measuring tape

  To measure swelling in the upper arm, a soft tape measure to measure the circumference of the arm at multiple points at the writs, mid-forearm, axilla, and oblique. A 2cm difference between arms at each area of the wrist, mid-forearm, axilla, and oblique shoulder is not optimal. Less than 2cm difference between arms at each area of the wrist, mid-forearm, axilla, and oblique shoulder is optimal.

  Preop appointment, Postop Day 42, Day 84, Day 168, Day 364

Secondary Outcomes (2)

• Visual Analogue Scale Measured by Scale

  Preop appointment, Postop Day 42, Day 84, Day 168, Day 364

• Range of Motion Measured by a Goniometer

  Preop appointment, Postop Day 42, Day 84, Day 168, Day 364

Study Arms (2)

Placebo

PLACEBO COMPARATOR

To assess the benefits of using the Incrediwear (Shoulder Sleeve) products for patients recovering from Arthroscopic Rotator Cuff Repair surgery for postoperative pain, range of motion, and swelling. We will compare patients with Incrediwear products or placebo Incrediwear products throughout a 12-week period with follow-ups up to 1-year post-surgery. The study will be double blinded as to the active Incrediwear sleeve vs placebo.

Device: Placebo

Incrediwear Product

ACTIVE COMPARATOR

To assess the benefits of using the Incrediwear (Shoulder Sleeve) products for patients recovering from Arthroscopic Rotator Cuff Repair surgery for postoperative pain, range of motion, and swelling. We will compare patients with Incrediwear products or placebo Incrediwear products throughout a 12-week period with follow-ups up to 1-year post-surgery. The study will be double blinded as to the active Incrediwear sleeve vs placebo.

Device: Shoulder Sleeve

Interventions

Placebo DEVICE

One group will receive placebo therapy (identical shoulder brace and arm sleeve absent of semiconductor fabric)

Placebo

Shoulder Sleeve DEVICE

One group will receive active therapy (active semiconductor embedded shoulder brace and arm sleeve)

Incrediwear Product

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing arthroscopic rotator cuff repair
• Patients aged 18-75
• Patients who are willing and able to adhere to follow-up schedule and protocol guidelines.
• Patients who are willing and able to sign corresponding research subject consent form.

You may not qualify if:

• Patient has a history of neurological conditions, including multiple sclerosis or Parkinson's disease
• Patient has severe medical condition, including recent myocardial infarction, unstable angina, heart failure, severe anemia
• Patient has had prior surgical treatment of a shoulder injury in the past 5 years
• Patient has chronic pain conditions unrelated to shoulder condition
• Patient has auto-immune or auto-inflammatory diseases
• Patient has used tobacco within the last 90 days
• Patient is not within the ages of 18-75
• Patient has poorly controlled diabetes with HgA1c \> 7.5
• Patient has an active infection (local or systemic)
• Patient is unwilling or unable to sign the corresponding research subject consent form
• Patient meets any other criteria or has any other condition that, in the opinion of the investigator, would prevent them from completing the study or that, in the opinion of the investigator, would confound study results.
• Against medical advice (AMA)
• Prisoner as indicated in the medical record

Sponsors & Collaborators

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

Study Sites (1)

Medical City Denton

Denton, Texas, 76210, United States

Location

Related Links

• Shoulder and Arm Sleeve

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Christopher L. Flowers

  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, Double-Blind, Placebo-Controlled Clinical Investigation

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 1, 2024
• Study Start: November 11, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 2, 2026
• Last Updated: May 8, 2025

Record last verified: 2025-05

Locations

US (1)