NCT06669741

Clinical Outcomes Related to Arthroscopic Rotator Cuff Repair Recovery Using Incrediwear

Clinical Outcomes Related to Arthroscopic Rotator Cuff Repair Recovery Using Semiconductor Embedded Therapeutic Garments From Incrediwear

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Texas Bone and Joint · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

Study Screening/pre-operative appointment * The surgeon confirms the participant meets the inclusion criteria and is scheduled for surgery in the next few weeks. * The surgeon will discuss the study and possible risks/benefits of being in the research. * The study team will measure the participant wrist, arm, and shoulder circumference. * The participant will rate their shoulder pain on a 1-10 Visual Analog Scale (VAS); shoulder function with the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire; shoulder function with the American Shoulder and Elbow Surgeons Score (ASES) scale, and function limitations using the Western Ontario Rotator Cuff Index (WORC) questionnaire. * The study team will measure the patient's shoulder's range of motion, stability, and strength. * Radiographic assessments may be analyzed if already indicated for patient care and included in standard of care procedure. • Day of Surgery * A study packet will be given to the participant by the study staff. The packet will include a study number assignment, the products assigned, and the patient study journal. The participant, surgeon, and clinical staff will not know which group the participant is in. * After surgery, the surgeon and PI, Dr. Flowers, will place the shoulder brace and arm sleeve according to the random assignment in the study packet. An abduction sling will then be placed on top of the shoulder brace and arm sleeve by Dr. Flowers. * Participant will be instructed to wear the shoulder brace and arm sleeve for at least 20 hours per day, including overnight, for 12 weeks post-surgery. * Participant will be instructed on the length of time to wear the shoulder abduction sling by the surgeon. * The clinical staff will take arm circumference measurements post-surgery. • Postoperative Recovery: Weeks 1-12 * Follow-up visits will be at 2 weeks, 6 weeks, and 12 weeks post-surgery. During follow-up visits: * The clinical staff will take arm swelling measurements. * Participant shoulder pain on a 1-10 Visual Analog Scale (VAS); shoulder function with the Disabilities of the Arm, Shoulder, and Hand (DASH), American Shoulder and Elbow Surgeons score (ASES), and Western Ontario Rotator Cuff Index (WORC) questionnaires. * The clinical staff will measure shoulder's range of motion, stability, and strength. * Radiographic assessments may be analyzed if already indicated for patient care and included in standard of care procedure. * Daily reported measures include: * Participant will record pain medication type and quantity taken in a medications log. Only medications related to the treatment of shoulder pain or function will be required to be reported. * Participant will rate shoulder pain severity on a 1-10 VAS in a pain diary log. * Participant will record how long they have worn the shoulder brace and arm sleeve in device usage log. * At the 12th week follow-up visit all study products, including the shoulder brace, arm sleeve, medications log, pain diary log, and device usage log. • Postoperative Recovery: 6 months and 1 year post surgery * A follow-up phone call after 6 months and 1-year post-surgery will be administered. * Participant will be asked to rate shoulder pain on a 1-10 Visual Analog Scale (VAS) and shoulder function with the Disabilities of the Arm, Shoulder, and Hand (DASH), American Shoulder and Elbow Surgeons score (ASES), and Western Ontario Rotator Cuff Index (WORC) questionnaires.

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

Interventions

Type	Name	Description
DEVICE	Placebo	One group will receive placebo therapy (identical shoulder brace and arm sleeve absent of semiconductor fabric)
DEVICE	Shoulder Sleeve	One group will receive active therapy (active semiconductor embedded shoulder brace and arm sleeve)

Timeline

• Start date: 2024-11-11
• Primary completion: 2026-12-01
• Completion: 2026-12-02
• First posted: 2024-11-01
• Last updated: 2025-05-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study