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New treatment option for Rotator Cuff Tears
Official title Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation
ClinicalTrials.gov ID: NCT06289686
What this study is testing
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- Ability to undergo surgery to repair rotator cuff tear
- Willingness to commit to study procedures including study intervention and a 12-month follow-up
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- Patients who have high-grade partial thickness tears where the surgeon elects to complete the tear during surgery before repairing the tendon(s)
- 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 (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
The study team makes the final eligibility decision.
Where it's taking place
- Air Force Academy, Colorado, United States
- Bethesda, Maryland, United States
- Chapel Hill, North Carolina, United States
- Durham, North Carolina, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Air Force Academy, Colorado, United States; Bethesda, Maryland, United States; Chapel Hill, North Carolina, United States; Durham, North Carolina, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.