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New treatment option for Massive Rotator Cuff Tear
Official title Effects Of Biceps Transposition Without Tenotomy For Augmentation Of Massive Rotator Cuff Repairs
ClinicalTrials.gov ID: NCT07375277
What this study is testing
- What it's testing
- This prospective, single-arm interventional study will evaluate the effects of long head of the biceps tendon (LHBT) transposition without tenotomy as an augmentation technique for arthroscopic partial repair in adults with massive rotator cuff tears. Consecutive eligible patients undergoing arthroscopic partial rotator cuff repair plus tenotomy-sparing LHBT transposition augmentation at Balikesir City Hospital (Balikesir, Turkiye) will be enrolled and followed for 12 months.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 years or older
- Diagnosis of a massive rotator cuff tear on preoperative MRI, defined as a full-thickness tear involving at least two tendons and/or a tear with a...
- Planned arthroscopic partial rotator cuff repair with augmentation using tenotomy-sparing long head of the biceps tendon (LHBT) transposition
- Persistence of symptoms despite at least 3 months of standard nonoperative treatment
- Intact LHBT confirmed intraoperatively
You likely can't join if
- Exclusion Criteria:
- Tear patterns not requiring augmentation (e.g., preserved rotator cable patterns)
- Neurologic conditions, inflammatory arthritis, active infection, or systemic conditions that may affect shoulder function or prevent protocol...
- Inability to provide informed consent
- Expected nonadherence to follow-up or rehabilitation protocol
See the full eligibility criteria
- Age 18 years or older
- Diagnosis of a massive rotator cuff tear on preoperative MRI, defined as a full-thickness tear involving at least two tendons and/or a tear with a greatest dimension greater than 5 cm
- Planned arthroscopic partial rotator cuff repair with augmentation using tenotomy-sparing long head of the biceps tendon (LHBT) transposition
- Persistence of symptoms despite at least 3 months of standard nonoperative treatment
- Intact LHBT confirmed intraoperatively
- Willingness and ability to attend scheduled follow-up visits (baseline, 3 months, and 12 months)
- Provision of written informed consent
- Exclusion Criteria:
- Tear patterns not requiring augmentation (e.g., preserved rotator cable patterns)
- Neurologic conditions, inflammatory arthritis, active infection, or systemic conditions that may affect shoulder function or prevent protocol rehabilitation
- Inability to provide informed consent
- Expected nonadherence to follow-up or rehabilitation protocol
The study team makes the final eligibility decision.
Where it's taking place
- Balıkesir, Turkey (Türkiye)
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Balıkesir, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.
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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.