Clinical trial NCT06289686: MIRROR Project 44 - Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation
Official title: MIRROR Project 44 - Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Rotator Cuff Tears
Rotator Cuff Injuries
Surgery
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
Collaborators: name: Sparta Biopharma
name: Musculoskeletal Injury Rehabilitation Research for Operational Readiness
First posted: 2024-03-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rates of re-tear
timeFrame: Post-operation at 3-months, 6-months, and 12-months
Secondary outcomes:
measure: Change in the Visual Analogue Scale (VAS) from before surgery to after surgery
timeFrame: Pre-operation (baseline) and then post-operation at 3-months, 6-months, and 12-months
measure: Change in the return to activities of daily living (ADL) from before surgery to after surgery
timeFrame: Pre-operation (baseline) and then post-operation at 3-months, 6-months, and 12-months
measure: Change in the Concomitant medications (ConMeds) from before surgery to after surgery
timeFrame: Pre-operation (baseline) and then post-operation at 3-months, 6-months, and 12-months
measure: Change in the Single Assessment Numeric Evaluation (SANE) from before surgery to after surgery
timeFrame: Pre-operation (baseline) and then post-operation at 6-months, and 12-months
measure: Change in the American Shoulder and Elbow Surgeons Standardized Shoulder Form (ASES) from before surgery to after surgery
timeFrame: Pre-operation (baseline) and then post-operation at 6-months, and 12-months
measure: Change in the Constant-Murley Score from before surgery to after surgery
timeFrame: Pre-operation (baseline) and then post-operation at 6-months, and 12-months
measure: Change in the shoulder immobilization status from before surgery to after surgery
timeFrame: Post-operation at 3-months, 6-months, and 12-months
measure: Change in strength measurements from before surgery to after surgery
timeFrame: Pre-operation (baseline) and then post-operation at 6-months and 12-months
measure: Change in range of motion measurements from before surgery to after surgery
timeFrame: Pre-operation (baseline) and then post-operation at 6-months and 12-months
measure: Number of medical events/adverse events after surgery
timeFrame: Day of surgery and post-operation at 3-months, 6-months, and 12-months
measure: Cumulative number of steroid injections after surgery
timeFrame: Post-operation at 3-months, 6-months, and 12-months
measure: Number of unscheduled visits after surgery
timeFrame: Post-operation at 3-months, 6-months, and 12-months
measure: Number of for-cause imaging procedures
timeFrame: Post-operation at 3-months, 6-months, and 12-months
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: Duke University
name: Jonathan Dickens, MD
role: PRINCIPAL_INVESTIGATOR
References: