Rotator Cuff TearsPhase 4NCT06289686
Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation
A Phase 4 study testing Rotator cuff repairs with BioEnthesis augmentation and Rotator cuff repairs without BioEnthesis augmentation in people with Rotator Cuff Tears and Rotator Cuff Injuries, run by Brooke Army Medical Center at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Tears, Rotator Cuff Injuries, Surgery
- What is being tested?
- Rotator cuff repairs with BioEnthesis augmentation and Rotator cuff repairs without BioEnthesis augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesUnited States
- Study dates
- 28 Jul 2023to Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- Patients who have high-grade partial thickness tears where the surgeon elects to complete the tear during surgery before repairing the tendon(s)
Who cannot join
- 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
Show all 18Show fewer
- 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 (such as 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
10th Medical Group - Air Force Academy
Air Force Academy, Colorado, 80840
Travis J Dekker, MD, 505-228-6795, Travis.J.Dekker.mil@health.mil
- Recruiting
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Daniel J Song, MD, 301-295-4290, Daniel.J.Song.mil@health.mil
- Recruiting
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27514
Robert A Creighton, MD, 919-966-9166, alex_creighton@med.unc.edu
- Recruiting
Duke University
Durham, North Carolina, 27710
Robert Tisherman, MD, 919-858-1203, Robert.Tisherman@duke.edu
- Recruiting
Brooke Army Medical Center
San Antonio, Texas, 78234
David J Tennent, MD, 210-916-2048, David.J.Tennent.mil@health.mil
About this study
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
- Being tested
- Rotator cuff repairs with BioEnthesis augmentation, Rotator cuff repairs without BioEnthesis augmentation
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotator cuff repairs with BioEnthesis augmentationProcedure or surgery
Rotator cuff repair using BioEnthesis allograft patch
Rotator cuff repairs without BioEnthesis augmentationProcedure or surgery
Rotator cuff repair using standard of care sutures and anchors
| Study group | Role | What they receive |
|---|---|---|
| BioEnthesis | Experimental | Allogenic, acellular, biphasic allograft (BioEnthesis) Receives: Procedure: Rotator cuff repairs with BioEnthesis augmentation |
| Standard of Care | Active comparator | Standard rotator cuff repair (suture and anchor based technique) Receives: Procedure: Rotator cuff repairs without BioEnthesis augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: 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.
Measured: 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.)
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-operation at 3-months, 6-months, and 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start28 Jul 2023
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Sparta Biopharma
- Responsible party
- Principal investigator, David Tennent, Brooke Army Medical Center
- Investigators
- Jonathan Dickens, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289686
- Sponsor's protocol ID
- C.2023.080
- Status last verified
- Jul 2026
- First submitted
- 22 Feb 2024
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation
- ClinicalTrials.gov ID
- NCT06289686
- Acronym / sponsor ID
- C.2023.080
- Conditions
- Rotator Cuff Tears, Rotator Cuff Injuries, Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Collaborators
- Sparta Biopharma
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BioEnthesis | Experimental | Procedure: Rotator cuff repairs with BioEnthesis augmentationAllogenic, acellular, biphasic allograft (BioEnthesis) |
| Standard of Care | Active comparator | Procedure: Rotator cuff repairs without BioEnthesis augmentationStandard rotator cuff repair (suture and anchor based technique) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rotator cuff repairs with BioEnthesis augmentationRotator cuff repair using BioEnthesis allograft patch | Procedure or surgery | BioEnthesis |
| Rotator cuff repairs without BioEnthesis augmentationRotator cuff repair using standard of care sutures and anchors | Procedure or surgery | Standard of Care |
Primary outcome
Rates of re-tear
Time frame: Post-operation at 3-months, 6-months, and 12-months
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
13 secondary outcomes
Change in the Visual Analogue Scale (VAS) from before surgery to after surgery
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
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
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
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
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
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
Time frame: Post-operation at 3-months, 6-months, and 12-months
Change in strength measurements from before surgery to after surgery
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
Time frame: Pre-operation (baseline) and then post-operation at 6-months and 12-months
Number of medical events/adverse events after surgery
Time frame: Day of surgery and post-operation at 3-months, 6-months, and 12-months
Cumulative number of steroid injections after surgery
Time frame: Post-operation at 3-months, 6-months, and 12-months
Number of unscheduled visits after surgery
Time frame: Post-operation at 3-months, 6-months, and 12-months
Number of for-cause imaging procedures
Time frame: Post-operation at 3-months, 6-months, and 12-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- BioEnthesis WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan Dickens, MD principal investigator
Duke University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rotator cuff repairs with BioEnthesis augmentation and Rotator cuff repairs without BioEnthesis augmentation in people with Rotator Cuff Tears and Rotator Cuff Injuries, run by Brooke Army Medical Center at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David J Tennent, MD (210-916-2048, David.J.Tennent.mil@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of re-tear (time frame: Post-operation at 3-months, 6-months, and 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.