The purpose of this study is to see how well the ActiveMatrix® graft works at improving healing and function of the shoulder following rotator cuff repair surgery
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
1-2 tendon full thickness reparable rotator cuff tendon tear(s)
Failed conservative medical management of the rotator cuff tendon tear defined as: 4-6 weeks of formal physical therapy or guided home exercises and activity modification
Prior surgery on the index shoulder within 12 months of enrollment, including Latarjet procedures, superior labral treat from anterior to posterior (SLAP), and (failed) primary rotator cuff surgery,
Prior surgery for bone defects requiring bone implantation in the index shoulder,
Steroid injection into the index shoulder within 6 weeks of enrollment.
Subscapularis tear greater than 1/3 of tendon involvement requiring repair,
Parallel
ActiveMatrix® Dosage A
Other interventionThis group will receive ActiveMatrix® (AM) product dosage A (1cc AM diluted to 3cc with saline)
ActiveMatrix® Dosage B
Other interventionGroup 2 will receive ActiveMatrix® product dosage B (2cc AM diluted to 3cc with saline)
Saline injection
Procedure/SurgeryGroup 3 will receive saline injection
Change in Sugaya score as measured by Magnetic Resonance Imaging (MRI)
Sugaya classification is a classification system that is used to analyze postoperative rotator cuff tendon integrity
Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees.PROM will be measured on both sides
Change in shoulder function as assessed by the American Shoulder and Elbow Surgeons Shoulder Score (ASES)
The total score is weighted 50% for pain and 50% for function. The pain score is calculated by subtracting the VAS from 10 and multiplying it by 5. The 10 functional questions are scored on a 4-point scale (0-3) with a maximum functional score of 30. The raw functional score is then multiplied by 5/3 to make the maximum functional score out of 50 possible points. The pain and function scores are then added together to obtain the final ASES score (out of 100). Higher scores correlate to better outcomes.
Change in pain intensity as assessed by the Visual Analog Scale (VAS)
VAS is scored on a 100mm horizontal scale that represents the patients pain intensity. A higher score corresponds to increased pain intensity
Change in pain and functional disability as assessed by the Shoulder Pain and Disability Index (SPADI)
SPADI is a self-administered questionnaire that measures a combination of pain and functional disability. This contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability and each is scored from 0 = no pain and 10 = the worst pain imaginable. SPADI is scored from 0 to 130 with a high score representing more pain and disability.
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The University of Texas Health Science Center, Houston
Lead sponsor
Skye Biologics Holdings, LLC
Collaborator
