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

NCT04325789 | Completed DMC FDA Device

• 1 other identifier: AO20200427
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

healing; regenerative medicine; interpositional matrix; synthetic scaffold; full-thickness rotator cuff tear; enthesis regeneration

Outcome Measures

Primary Outcomes (1)

• Failure of the repair

  To determine if the use of the nanofiber scaffold changes the occurrence of postoperative rotator cuff repair (RCR) failure in patients older than 55 years

  24 months

Secondary Outcomes (6)

• Change in shoulder range of motion

  Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months postoperative

• Change in isometric rotator cuff muscle strength peak force

  Preoperative, 3 months, 6 months, 12 months, 24 months postoperative

• Change in patient-reported American Shoulder and Elbow Scores

  Preoperative, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months postoperative

• Change in patient-reported postoperative pain (Visual Analogue Scale - Pain)

  Preoperative, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months postoperative

• Change in patient-reported Single Assessment Numeric Evaluation (SANE) score

  Preoperative, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months postoperative

Study Arms (2)

Group 1 Control

NO INTERVENTION

Group 1 will serve as the control and undergo routine rotator cuff repair with suture anchors without the nanofiber scaffold.

Group 2 Scaffold

ACTIVE COMPARATOR

Group 2 will undergo rotator cuff repair with suture anchors and incorporation of the nanofiber scaffold.

Interventions

nanofiber scaffold DEVICE

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

Also known as: ROTIUM™ Bioresorbable Wick (Atreon Orthopedics)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 55 and older
• Able to provide informed consent
• Primary diagnosis of rotator cuff tear

You may not qualify if:

• Revision rotator cuff surgery
• Partial thickness rotator cuff tears
• Massive (greater than 5cm) rotator cuff tears
• Patients with current tobacco history

Sponsors & Collaborators

• Atreon Orthopedics: lead

Study Sites (4)

Central Indiana Orthopedics

Fishers, Indiana, 46037, United States

Location

Associated Orthopedists of Detroit

Saint Clair Shores, Michigan, 48080, United States

Location

The Christ Hospital & The Lindner Reseach Center at The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Steadman Hawkins Clinic of the Carolinas - Patewood

Greenville, South Carolina, 29615, United States

Location

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MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Brian L Badman, MD

  Central Indiana Orthopedics

  PRINCIPAL INVESTIGATOR

• Elsa I Englund Kayuha, MD

  Atreon Orthopedics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This is a single blinded study. The patient will be blinded to the treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Use of the nanofiber scaffold, in addition to SOC, during the rotator cuff repair is the intervention in this study. Study participants will be randomized into either the treatment or the control group. The control group will undergo routine rotator cuff repair without the scaffold to determine if improved healing is demonstrated with the graft. Group 1 (control) Group 2 (nanofiber scaffold)

Study Record Dates

• First Submitted: March 21, 2020
• First Posted: March 30, 2020
• Study Start: June 29, 2020
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)