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

Rotator Cuff Tears Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04325789
• Other study ID #: 2001815870
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 29, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: November 2023
• Source: Nanofiber Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 91
• Est. completion date: September 30, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

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

Locations

Country	Name	City	State
United States	The Christ Hospital & The Lindner Reseach Center at The Christ Hospital	Cincinnati	Ohio
United States	Central Indiana Orthopedics	Fishers	Indiana
United States	Steadman Hawkins Clinic of the Carolinas - Patewood	Greenville	South Carolina
United States	Associated Orthopedists of Detroit	Saint Clair Shores	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Atreon Orthopedics

Country where clinical trial is conducted

United States, 

References & Publications (38)

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* Note: There are 38 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in shoulder range of motion	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
Secondary	Change in isometric rotator cuff muscle strength peak force	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
Secondary	Change in patient-reported American Shoulder and Elbow Scores	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
Secondary	Change in patient-reported postoperative pain (Visual Analogue Scale - Pain)	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
Secondary	Change in patient-reported Single Assessment Numeric Evaluation (SANE) score	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
Secondary	Change in patient-reported Veteran Rand 12 (VR-12) score	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