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

NCT06289686 | Not Yet Recruiting Phase 4

• 1 other identifier: C.2023.080
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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

Rotator Cuff Tears; Rotator Cuff Injuries; Surgery

Outcome Measures

Primary Outcomes (1)

• Rates of re-tear

  Re-tear rates following rotator cuff repair using BioEnthesis versus standard of care. Assessed with (1) 12-month follow-up shoulder MRI and assigning Sugaya Classification, and (2) adverse events evaluation at each follow-up timepoint

  Post-operation at 3-months, 6-months, and 12-months

Secondary Outcomes (13)

• Change in the Visual Analogue Scale (VAS) from before surgery to after surgery

  Pre-operation (baseline) and then post-operation at 3-months, 6-months, and 12-months

• Change in the return to activities of daily living (ADL) from before surgery to after surgery

  Pre-operation (baseline) and then post-operation at 3-months, 6-months, and 12-months

• Change in the Concomitant medications (ConMeds) from before surgery to after surgery

  Pre-operation (baseline) and then post-operation at 3-months, 6-months, and 12-months

• Change in the Single Assessment Numeric Evaluation (SANE) from before surgery to after surgery

  Pre-operation (baseline) and then post-operation at 6-months, and 12-months

• Change in the American Shoulder and Elbow Surgeons Standardized Shoulder Form (ASES) from before surgery to after surgery

  Pre-operation (baseline) and then post-operation at 6-months, and 12-months

Study Arms (2)

BioEnthesis

EXPERIMENTAL

Allogenic, acellular, biphasic allograft (BioEnthesis)

Procedure: Rotator cuff repairs with BioEnthesis augmentation

Standard of Care

ACTIVE COMPARATOR

Standard rotator cuff repair (suture and anchor based technique)

Procedure: Rotator cuff repairs without BioEnthesis augmentation

Interventions

Rotator cuff repairs with BioEnthesis augmentation PROCEDURE

Rotator cuff repair using BioEnthesis allograft patch

BioEnthesis

Rotator cuff repairs without BioEnthesis augmentation PROCEDURE

Rotator cuff repair using standard of care sutures and anchors

Standard of Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Brooke Army Medical Center: lead
• Sparta Biopharma: collaborator
• Musculoskeletal Injury Rehabilitation Research for Operational Readiness: collaborator

Study Sites (2)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

Location

Related Links

• BioEnthesis Website

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Jonathan Dickens, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Sheean, MD

CONTACT

210-916-1280; Andrew.J.Sheean.mil@health.mil

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 4, 2024
• Study Start: July 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

US (2)