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Use of Nanoscaffold Augmentation in Rotator Cuff Repair: Clinical Outcome and Ultrasound Assessment of Healing Rates and Vascularity

NCT04361266 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-10-18

No results posted yet for this study

Summary

The purpose is to assess Rotium, a novel nanoscaffold, impact on healing of a repaired rotator cuff and compare to a repair without Rotium. Animal (sheep) models have shown both quicker and more organized healing when Rotium is used, but there are no studies to confirm these outcomes translate to human population.

Hypothesis: Rotium rotator cuff repairs will heal both quicker and better than traditional rotator cuff repair techniques.

Conditions

  • Rotator Cuff Tears
  • Rotator Cuff Injuries
  • Rotator Cuff Syndrome of Shoulder and Allied Disorders

Interventions

DEVICE

Rotium nanoscaffold

Rotium bioabsorbable nanoscaffold placed between bone-tendon interface of rotator cuff repair construct

PROCEDURE

Control arm rotator cuff repair

Standard rotator cuff repair without Rotium

Sponsors & Collaborators

  • Atreon Orthopedics

    collaborator INDUSTRY

  • Joshua Szabo, MD

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2023-08-01
Completion
2023-11-01

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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 NCT04361266 on ClinicalTrials.gov