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Trial record 1 of 1 for:    04325789
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Rotator Cuff Healing Using a Nanofiber Scaffold in Patients Greater Than 55 Years

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ClinicalTrials.gov Identifier: NCT04325789
Recruitment Status : Recruiting
First Posted : March 30, 2020
Last Update Posted : April 6, 2022
Sponsor:
Information provided by (Responsible Party):
Nanofiber Solutions ( Atreon Orthopedics )

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

Condition or disease Intervention/treatment Phase
Rotator Cuff Tears Device: nanofiber scaffold Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Use of the nanofiber scaffold during the rotator cuff repair is the intervention in this study. Study participants will be randomized into either treatment or 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)

Masking: Single (Participant)
Masking Description: This is a single blinded study. The patient will be blinded to the treatment group.
Primary Purpose: Treatment
Official Title: A Prospective Randomized Multicenter Evaluation of Rotator Cuff Healing Using a Nanofiber Scaffold in Patients Greater Than 55 Years
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : May 1, 2026

Arm Intervention/treatment
No Intervention: Group 1 Control
Group 1 will serve as the control and undergo routine rotator cuff repair with suture anchors without the nanofiber scaffold.
Active Comparator: Group 2 Scaffold
Group 2 will undergo rotator cuff repair with suture anchors and incorporation of the nanofiber scaffold.
Device: nanofiber scaffold
Utilization of the interpositional nanofiber scaffold to augment the rotator cuff repair.
Other Name: ROTIUM™ Bioresorbable Wick (Atreon Orthopedics)




Primary Outcome Measures :
  1. Failure of the repair [ Time Frame: 24 months ]
    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


Secondary Outcome Measures :
  1. Change in shoulder range of motion [ Time Frame: Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months postoperative ]
    Patients range of motion including forward flexion, abduction and external rotation will be measured preopertively and postoperatively with a manual goniometer at 6 weeks, 3 months, 6 months, 12 months and 24 months postoperatively to measure for differences.

  2. Change in isometric rotator cuff muscle strength peak force [ Time Frame: Preoperative, 3 months, 6 months, 12 months, 24 months postoperative ]
    To determine if the use of the nanofiber scaffold changes postoperative isometric muscle strength following RCR using a Lafayette muscle dynometer. The contralateral shoulder will be assessed for comparison. Measurements will be recorded in peak force and pounds of force.

  3. Change in patient-reported American Shoulder and Elbow Scores [ Time Frame: Preoperative, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months postoperative ]
    To determine if there is a difference in American Shoulder and Elbow scores of patients with rotator cuff tears treated with and without the nanofiber scaffold measured at preoperative visit, 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months after surgery.

  4. Change in patient-reported postoperative pain (Visual Analogue Scale - Pain) [ Time Frame: Preoperative, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months postoperative ]
    Patient reported postoperative visual analogue pain (on a scale of 0-10), measured preoperatively and postoperatively will be assessed for a difference. Pain scores will be checked at 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months after surgery.

  5. Change in patient-reported Single Assessment Numeric Evaluation (SANE) score [ Time Frame: Preoperative, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months postoperative ]
    Patient reported SANE score (on a scale of 0 to 100%), measured preoperatively and postoperatively will be assessed for a difference; Scores will be checked at 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months after surgery.

  6. Change in patient-reported Veteran Rand 12 (VR-12) score [ Time Frame: Preoperative, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months postoperative ]
    Patient reported VR-12 (Veteran rand) will be compared measured postoperatively will be assessed for a difference; Scores will be checked at 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months after surgery.



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 55 and older
  2. Able to provide informed consent
  3. Primary diagnosis of rotator cuff tear

Exclusion Criteria:

  1. Revision rotator cuff surgery
  2. Partial thickness rotator cuff tears
  3. Massive (greater than 5cm) rotator cuff tears
  4. Patients with current tobacco history

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04325789


Contacts
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Contact: Elsa l Englund Kayuha, MD 614-975-6645 elsa.englund@nanofibersolutions.com

Locations
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United States, Florida
Andrews Institute for Orthopaedics & Sports Medicine Not yet recruiting
Gulf Breeze, Florida, United States, 32561
Contact: Josh J Cook, BS    850-916-8590    joshua.cook@andrewsref.org   
Principal Investigator: Christopher P O'Grady, MD         
United States, Indiana
Central Indiana Orthopedics Recruiting
Fishers, Indiana, United States, 46037
Contact: Brian Badman, MD    800-622-6575      
Principal Investigator: Brian L Badman, MD         
United States, Kentucky
Baptist Health System Recruiting
Lexington, Kentucky, United States, 40503
Contact: Hailey Taylor, MBA    859-260-4489    hailey.taylor2@bhsi.com   
Principal Investigator: Brent J Morris, MD         
United States, Michigan
Associated Orthopedists of Detroit Recruiting
Saint Clair Shores, Michigan, United States, 48080
Contact: Sheila Vanderschaaf    586-779-7970    svanderschaaf@associatedortho.org   
Contact: Jennifer Wiesemann    (586) 779-7970    jwiesemann@associatedortho.org   
Principal Investigator: Shariff K Bishai, DO, MS         
United States, Ohio
The Christ Hospital & The Lindner Reseach Center at The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Janet L Walt, MA BSN RN    513-585-1786    janet.walt@thechristhospital.com   
Principal Investigator: Paul J Favorito, MD         
United States, South Carolina
Steadman Hawkins Clinic of the Carolinas - Patewood Recruiting
Greenville, South Carolina, United States, 29615
Contact: Kyle Adams    864-454-7458    kyle.adams@hawkinsfoundation.com   
Principal Investigator: Stephan G Pill, MD         
Sponsors and Collaborators
Atreon Orthopedics
Investigators
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Principal Investigator: Brian L Badman, MD Central Indiana Orthopedics
Study Director: Elsa I Englund Kayuha, MD Atreon Orthopedics
Publications:

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Responsible Party: Atreon Orthopedics
ClinicalTrials.gov Identifier: NCT04325789    
Other Study ID Numbers: 2001815870
First Posted: March 30, 2020    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Nanofiber Solutions ( Atreon Orthopedics ):
healing
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries