Clinical Outcomes Related to Arthroscopic Rotator Cuff Repair Recovery Using Incrediwear

Part of paid clinical trials in Denton, Texas.

Sponsor
Texas Bone and Joint
Study ID
NCT06669741
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 11, 2024
Status verified
May 2025
Primary completion
Dec 1, 2026
Completion
Dec 2, 2026

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    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.
  • Active Comparator: Incrediwear Product
    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.

Primary Outcome Measure

Arm Circumference Measure with a Measuring tape [ Time Frame: Preop appointment, Postop Day 42, Day 84, Day 168, Day 364 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Medical City DentonDentonTexas76210-

Find similar trials in Denton, TX

By research site
Medical City Denton· Denton, TX

Related Studies