Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBrooke Army Medical Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Rotator cuff repairs with BioEnthesis augmentation
Procedure/SurgeryRotator cuff repair using BioEnthesis allograft patch
Rotator cuff repairs without BioEnthesis augmentation
Procedure/SurgeryRotator cuff repair using standard of care sutures and anchors
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: BioEnthesisExperimental treatment 1 intervention
Group B: Standard of CareActive comparator 1 intervention
Trial outcomes
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
Time frame
Post-operation at 3-months, 6-months, and 12-monthsSecondary outcomes
1
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-months2
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-months3
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-months4
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-monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Brooke Army Medical Center
Lead sponsor
Sparta Biopharma
Collaborator
Source ClinicalTrials.gov