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

Not Applicable

Active, not recruiting

• Conditions: Rotator Cuff Tears; Full-thickness Rotator Cuff Tears
• Interventions: Device: nanofiber scaffold

• Registration Number: NCT04325789
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2020-03-21
• Study First Submitted QC: 2020-03-25
• Study First Posted: 2020-03-30
• Study Start: 2020-06-29
• Status Verified: 2024-12
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-23
• Primary Completion: 2025-03-15
• Study Completion: 2025-03-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 91

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Failure of the repair	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

Name	Time	Method
Change in shoulder range of motion	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.
Change in patient-reported Single Assessment Numeric Evaluation (SANE) score	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.
Change in patient-reported American Shoulder and Elbow Scores	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.
Change in patient-reported Veteran Rand 12 (VR-12) score	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.
Change in isometric rotator cuff muscle strength peak force	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.
Change in patient-reported postoperative pain (Visual Analogue Scale - Pain)	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.

Trial Locations

Locations (4)

Associated Orthopedists of Detroit; 🇺🇸 Saint Clair Shores, Michigan, United States

Central Indiana Orthopedics; 🇺🇸 Fishers, Indiana, United States

The Christ Hospital & The Lindner Reseach Center at The Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States

Steadman Hawkins Clinic of the Carolinas - Patewood; 🇺🇸 Greenville, South Carolina, United States