MIRROR Project 44 - Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation

Brooke Army Medical Center

Status and phase

Not yet enrolling

Phase 4

Conditions

Surgery

Rotator Cuff Injuries

Rotator Cuff Tears

Treatments

Procedure: Rotator cuff repairs with BioEnthesis augmentation

Procedure: Rotator cuff repairs without BioEnthesis augmentation

Study type

Interventional

Funder types

Other U.S. Federal agency

Other

Identifiers

NCT06289686

C.2023.080

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)

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 including Type II-IV SLAP lesion, Bankart lesion, Hill Sachs lesion, 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