A Phase 4 interventional study of Rotator cuff repairs with BioEnthesis augmentation and Rotator cuff repairs without BioEnthesis augmentation in Rotator Cuff Tears, Rotator Cuff Injuries and Surgery, sponsored by Brooke Army Medical Center. Recruiting at 5 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Brooke Army Medical Center · Phase 4, Interventional, and Treatment
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.
631 studies on the registry are indexed under Rotator Cuff Injuries; 156 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 456 interventional studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →Brooke Army Medical Center is the lead sponsor of 94 studies on the registry; 11 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 2 (25%) have results posted.
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Exclusion Criteria:
Allogenic, acellular, biphasic allograft (BioEnthesis)
Procedure: Rotator cuff repairs with BioEnthesis augmentation
Standard rotator cuff repair (suture and anchor based technique)
Procedure: Rotator cuff repairs without BioEnthesis augmentation
Rotator cuff repair using BioEnthesis allograft patch
Rotator cuff repair using standard of care sutures and anchors
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
Time frame: Post-operation at 3-months, 6-months, and 12-months
Change in the Visual Analogue Scale (VAS) from before surgery to after surgery
A tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable.
Time frame: 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
A survey asking patients if and when patients have returned to various activities of daily living, such as work, driving, physical/recreational activities.
Time frame: 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
A survey asking patients to indicate any medications they are taking at the time of the survey (e.g., Acetaminophen, opioids, NSAIDs, etc.)
Time frame: 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
The SANE score is a validated patient reported outcome measure. It is a single question score that asks, "how would you rate your condition today as a percentage of normal (0% to 100% scale with 100% being normal)?" The SANE score is collected as standard of care.
Time frame: 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
The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points
Time frame: Pre-operation (baseline) and then post-operation at 6-months, and 12-months
Change in the Constant-Murley Score from before surgery to after surgery
The Constant-Murley Score is a multi-item functional scale assessing pain, activities of daily living, range of motion, and strength of the affected shoulder. Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively.
Time frame: Pre-operation (baseline) and then post-operation at 6-months, and 12-months
Change in the shoulder immobilization status from before surgery to after surgery
A survey asking patients to indicate if they wore a sling after their surgery and for how long they wore their sling.
Time frame: Post-operation at 3-months, 6-months, and 12-months
Change in strength measurements from before surgery to after surgery
Strength measurements will be collected using a handheld dynamometer while the arm is in two positions: (1) abduction with the arm in the scapular plane, and (2) external rotation while the arm is adducted and the elbow is flexed to 90 degrees
Time frame: Pre-operation (baseline) and then post-operation at 6-months and 12-months
Change in range of motion measurements from before surgery to after surgery
Range of motion measurements will be collected using a goniometer while the arm moves through four movements: (1) forward flexion, (2) abduction, (3) external rotation, and (4) internal rotation
Time frame: Pre-operation (baseline) and then post-operation at 6-months and 12-months
Number of medical events/adverse events after surgery
A count of the number of post-operative medical/adverse events for the affected shoulder after the patient's surgery.
Time frame: Day of surgery and post-operation at 3-months, 6-months, and 12-months
Cumulative number of steroid injections after surgery
A count of the number of post-operative steroid injections obtained for the affected shoulder after the patient's surgery.
Time frame: Post-operation at 3-months, 6-months, and 12-months
Number of unscheduled visits after surgery
A count of the number of clinic visits outside the typical standard of care visits for the affected shoulder after the patient's surgery.
Time frame: Post-operation at 3-months, 6-months, and 12-months
Number of for-cause imaging procedures
A count of the number of radiographic imaging obtained, and the type of imaging obtained, for the affected shoulder after the patient's surgery.
Time frame: Post-operation at 3-months, 6-months, and 12-months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Brooke Army Medical Center