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Clinical Outcomes Related to Arthroscopic Rotator Cuff Repair Recovery Using Incrediwear

NCT06669741 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-05-08

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • INCREDIWEAR HOLDINGS, INC.

    collaborator INDUSTRY

  • Texas Bone and Joint

    lead OTHER

Principal Investigators

  • Christopher L. Flowers · Texas Bone and Joint

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-11
Primary Completion
2026-12-01
Completion
2026-12-02
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06669741 on ClinicalTrials.gov