Clinical Trials

Inclusion Criteria:

Subjects MUST meet ALL the following criteria to be included in the study:

- The subject has signed the IRB approved Informed Consent Form (ICF) specific to this
study prior to enrollment

- Is male or female ≥ sixty-five (65) years of age

- Positive diagnostic imaging by MRI within 9 months of enrollment of the index shoulder
indicating a full thickness MRCT:

- Measuring ≥ 5 cm in diameter

- Involving ≥ two tendons

- Functional deltoid muscle and preserved passive range of motion on physical
examination

- Documented VAS score > 30 mm pain

- Failed non-operative treatment of at least 3 months from the initial treatment to
include one or more of the following:

- Oral analgesics

- Anti-inflammatory medication (e.g., ibuprofen, naproxen)

- Corticosteroid injection(s)

- Physical therapy

- Activity modification

- Rest (sling used)

- Must be able to read and understand the approved Informed Consent Form (written and
oral)

- Must be in general good health (as determined by the Investigator) based on screening
assessments and medical history

- Must be independent, ambulatory, and can comply with all post-operative evaluations,
visits, and electronic database collection

Intra-operative Inclusion Criteria

Subjects MUST meet the following criteria to be randomized in the study:

- Full thickness tear

- Tear size ≥ 5 cm in diameter

- Tear involving ≥ two tendons

Exclusion Criteria:

Subjects will be excluded from the study, if they meet ANY of the following individual
exclusion criteria:

- Known allergy to the device material (copolymer of PLA (poly (lactic acid) and
-?-caprolactone)

- Evidence of the following conditions:

- Severe gleno-humeral or acromio-humeral arthritis

- Full thickness cartilage loss as seen on MRI

- History within the past 5 years of anterior or posterior shoulder subluxation or
dislocation as determined by history, examination, or radiographic findings

- Pre-existing deltoid defect or deltoid palsy

- Major joint trauma, infection, or necrosis

- Partial thickness tears of the supraspinatus

- Fully reparable rotator cuff tear [Tear of less than 5 cm in diameter (or < 4
cm2) with retractable tendon that can be fully repaired]

- Known neurovascular compromise

- Complete deltoid muscle palsy

- Traumatic muscle tears of the pectoralis or deltoid

- The subject requires concomitant:

- Subscapularis repair

- Labral repair of any type

- Biceps tenodesis

- Previous surgery of the index shoulder in the past 1 year, excluding diagnostic
arthroscopy

- The subject's condition is bilateral and rotator cuff repair is scheduled or to be
scheduled over the course of this study for the contra lateral shoulder

- Major medical condition that could affect quality of life and influence the results of
the study (e.g., rheumatoid arthritis)

- The subject has documented evidence of a history (e.g., liver testing) of drug/alcohol
abuse within 12 months of enrollment

- The subject's condition represents a worker's compensation case

- The subject is currently involved in a health-related litigation procedure

- Females of child-bearing potential who are pregnant or plan to become pregnant.

- Concurrent participation in an investigational clinical study one month prior to
enrollment or during the entire study period

- The subject is physically or mentally compromised (e.g., currently being treated for a
psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that
the Investigator judges the subject to be unable or unlikely to remain compliant to
follow-up

- The subject is receiving prescription narcotic pain medication for conditions
unrelated to the index shoulder condition

- The subject currently has an acute infection in the area surrounding the surgical
site.

- Baseline WORC score less than 420

Intra-operative Exclusion Criteria:

Subjects will not be randomized and will be terminated from the study if they meet ANY of
the following individual intra-operative exclusion criteria:

- Rotator cuff is/presents with:

- Fully reparable with adequate tissue and muscle quality (equivalent to Goutallier
stage 1 or 2)

- Partial thickness tear of the supraspinatus

- Evidence of significant osteoarthritis

- The subject requires concomitant:

- Subscapularis repair

- Labral repair of any type

- Biceps tenodesis

- Coracoacromial ligament functional deficiency or shoulder instability is identified

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/8/2024. Questions regarding updates should be directed to the study team contact.