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

November 9, 2023 updated by: Atreon Orthopedics

A Prospective Randomized Multicenter Evaluation of Rotator Cuff Healing Using a Nanofiber Scaffold in Patients Greater Than 55 Years

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. INTRODUCTION

    This document is a protocol for a human research study. This study is to be conducted according to United States standards of Good Clinical Practice in accordance with applicable Federal regulations and institutional research policies and procedures.

    Despite numerous advancements in surgical techniques and over 250,000 procedures currently performed annually in the United States, failure of tendon healing following rotator cuff surgery occurs frequently with reports as high as 94%. Nonhealing can lead to persistent pain, poor outcomes, and a significant economic burden to society when revision surgery is required. Several factors have been associated with poor tendon healing with age greater than 60 years shown to be a significant risk factor due to diminishing vascularity at the bone tendon interface where the tear typically originates. While numerous techniques have been devised to improve fixation over the past several decades, very few have been developed to address or enhance the biology at the repair site. Rotium nanofiber is a recent FDA approved scaffold (FDA 510(K) #K183236) that has been shown to improve tendon healing to bone in animal studies. It works to mimic the extracellular matrix and helps concentrates and bind cells at the repair site providing a better organizational structure of the healing tissue. The purpose of the current study is to assess if use of the scaffold significantly improves rotator cuff healing and enhances strength in patients at higher risk of perioperative failure of the repair.

  2. BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE

    Rotator cuff tears are a frequent cause of shoulder pain and disability in the elderly population. Typically, when conservative measures fail, surgery is often advised. A successful clinical outcome is felt to be heavily predicated on healing of the tendon to the bone. Despite numerous surgical and technical advancements over the past two decades not all repairs heal, with re-tear, or failure-to-heal, remaining the number one complication associated with rotator cuff surgery. This in turn creates a hefty economic burden on society whereupon surgeries are being performed with poor eventual outcomes and ultimately wasted resources.

    While reasons for failure are multifactorial, a strong correlation has been associated with advancing age. In an observational study on the natural history of rotator cuff disease, patients younger than 50 years old rarely had rotator cuff tears whereas those greater than 60 had a statistically significant greater incidence of unilateral and bilateral tears. Advancing age is believed to alter and change the intrinsic properties of the tendon leading to stiffness, hypovascularity and overall impairment of the biology of tendon healing. Furthermore, when repairs fail, they typically do so within the first four months of surgery. Means, therefore, to enhance the zone of the repair by increasing the cellularity immediately following surgery may improve the overall healing and lessen failures.

    Recently, nanofiber scaffolds have demonstrated the ability to mimic the extracellular matrix and help structure, organize, and proliferate cellular material. They do so by working, in essence, like a sponge when incorporated into the repair site, helping to bind, organize, and promote cell migration. This in effect, creates a less haphazard arrangement and induces better organization of healing tissue at the cellular level. Rotium, is an FDA-approved, nonwoven, microfiber matrix composed of PLCL (poly L-lactide-co-caprolactone) and PGL (polyglycolide) that is indicated for use in rotator cuff repair to enhance healing at the bone tendon interface. The implant is inserted under the rotator cuff tendon and placed on top of the greater tuberosity at the time of surgery and typically positioned over a suture. In a recent animal study performed at Colorado State University, a nearly 75% increased strength of repair was demonstrated at twelve weeks in those tendons treated with the graft. This will be the first prospective randomized clinical study in humans assessing for a difference in healing and strength in a population of patients considered at high risk for postoperative failure of the repair.

  3. STUDY OBJECTIVES

Utilizing a randomized controlled trial, this study seeks to evaluate if there is a difference in post-operative healing, strength, and functional outcomes in patients older than 55 years with rotator cuff tears treated with and without the nanofiber scaffold.

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Indiana
      • Fishers, Indiana, United States, 46037
        • Central Indiana Orthopedics
    • Michigan
      • Saint Clair Shores, Michigan, United States, 48080
        • Associated Orthopedists of Detroit
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital & The Lindner Reseach Center at The Christ Hospital
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Steadman Hawkins Clinic of the Carolinas - Patewood

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • ROTIUM™ Bioresorbable Wick (Atreon Orthopedics)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months postoperative
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.
Preoperative, 3 months, 6 months, 12 months, 24 months postoperative
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.
Preoperative, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months postoperative
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.
Preoperative, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months postoperative
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.
Preoperative, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months postoperative
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.
Preoperative, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atreon Orthopedics

Investigators

  • Principal Investigator: Brian L Badman, MD, Central Indiana Orthopedics
  • Study Director: Elsa I Englund Kayuha, MD, Atreon Orthopedics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2020

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

March 21, 2020

First Submitted That Met QC Criteria

March 25, 2020

First Posted (Actual)

March 30, 2020

Study Record Updates

Last Update Posted (Estimated)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 9, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2001815870

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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