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Purpose

Rotator cuff (RC) injuries are particularly prevalent, difficult to repair, and attachment between the bone and tendon is notoriously difficult to achieve. The most common method and current standard of care (SOC) for reattaching connective tissues (e.g., ligaments, tendons) to bone typically involves suture anchor-based techniques, but this is fraught with problems. More specifically, re-tearing of the connective tissue after this procedure occurs in 30-60% of cases, and can be even higher in patients who engage in smoking, have a diagnosis of diabetes, etc. To address these clinical challenges, Sparta Biopharma Inc. (Sparta) developed a unique technology, called BioEnthesis, to improve the connection between the tendon and bone. Pre-clinical in vivo studies demonstrated that the biphasic bovine cancellous matrix regenerated at the bone-soft tissue interface-thereby leading to high structural integrity and will likely lead to reduced re-tear rates over time. The investigators hypothesize that patients in this interventional cohort will experience enhanced mobility, reduced pain, and less re-tears after RC procedures versus a standard suture anchor-based repair.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • DEERS-eligible - Adults, between the ages of 18-65 (inclusive) - Presenting with a rotator cuff tear that is reparable surgically (a reparable tear is defined as tear of the RC where it is possible to bring the retracted tendon edge back to the greater tuberosity of the humerus under minimal tension) - Ability to undergo surgery to repair rotator cuff tear - Willingness to commit to study procedures including study intervention and a 12-month follow-up - Fluency in speaking, reading, comprehending English - 1-2 tendon full thickness reparable RC tear (full thickness tear is defined as a tear that involves the majority of supraspinatus and less than half of the infraspinatus under minimal tension, with no subscapularis involvement beyond the upper border) - Patients who have high-grade partial thickness tears where the surgeon elects to complete the tear during surgery before repairing the tendon(s)

Exclusion Criteria

  • Previous shoulder surgery (excluding acromioplasty or diagnostic arthroscopy) - Inability to receive an MRI - Current (within the past 6 months) tobacco user - Unwilling to remain tobacco free for the duration of the study - Current lower limb injuries requiring walking assist devices such as crutches and walkers - Diagnosed with systemic arthritis - Significant neck pathology - Active joint or systemic infection - Currently enrolled, or plans to enroll, in another clinical trial during this study (that would affect the patient's safety or results of this trial) - Significant muscle paralysis of the shoulder girdle - Currently pregnant or plans to become pregnant during this study - Inability of the surgeon to repair the tear with remaining defect no greater than 10 mm in diameter - Inability of the surgeon to repair the tear with less than 1cm of medialization - Evidence of other significant shoulder pathology (such as Grade III osteoarthritis) - Has a history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or drug abuse or addiction - Major medical illness that would preclude undergoing surgery - Major psychiatric illness or developmental handicap - Goutallier III classification and above

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BioEnthesis 		Allogenic, acellular, biphasic allograft (BioEnthesis)
  • Procedure: Rotator cuff repairs with BioEnthesis augmentation
    Rotator cuff repair using BioEnthesis allograft patch
Active Comparator
Standard of Care 		Standard rotator cuff repair (suture and anchor based technique)
  • Procedure: Rotator cuff repairs without BioEnthesis augmentation
    Rotator cuff repair using standard of care sutures and anchors

Recruiting Locations

10th Medical Group - Air Force Academy
Air Force Academy, Colorado 80840
Contact:
Travis J Dekker, MD
505-228-6795
Travis.J.Dekker.mil@health.mil

Walter Reed National Military Medical Center
Bethesda, Maryland 20889
Contact:
Daniel J Song, MD
301-295-4290
Daniel.J.Song.mil@health.mil

University of North Carolina Chapel Hill
Chapel Hill, North Carolina 27514
Contact:
Robert A Creighton, MD
919-966-9166
alex_creighton@med.unc.edu

Duke University
Durham, North Carolina 27710
Contact:
Robert Tisherman, MD
919-858-1203
Robert.Tisherman@duke.edu

Brooke Army Medical Center
San Antonio, Texas 78234
Contact:
David J Tennent, MD
210-916-2048
David.J.Tennent.mil@health.mil

More Details

Status
Recruiting
Sponsor
Brooke Army Medical Center

Study Contact

David J Tennent, MD
210-916-2048
David.J.Tennent.mil@health.mil

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.