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Rotator Cuff Healing Using a Nanofiber Scaffold in Patients Greater Than 55 Years

NCT04325789 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2026-04-29

No results posted yet for this study

Summary

Randomized controlled trial of patients over the age of 55 treated with and without a nanofiber scaffold during rotator cuff repair.

Conditions

  • Rotator Cuff Tears
  • Full-thickness Rotator Cuff Tears

Interventions

DEVICE

nanofiber scaffold

Utilization of the interpositional nanofiber scaffold to augment the rotator cuff repair.

Sponsors & Collaborators

  • Atreon Orthopedics

    lead INDUSTRY

Principal Investigators

  • Brian L Badman, MD · Central Indiana Orthopedics

  • Elsa I Englund Kayuha, MD · Atreon Orthopedics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-29
Primary Completion
2025-12-30
Completion
2025-12-30
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 NCT04325789 on ClinicalTrials.gov