An interventional study of Rotator Cuff Repair and Long Head of the Biceps Tendon Transposition in Rotator Cuff Tears, Rotator Cuff Injuries and Massive Rotator Cuff Tear, sponsored by Tam Anh Research Institute. Recruiting at 1 site in Vietnam. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Tam Anh Research Institute · Not applicable, Interventional, and Treatment
Large-to-massive rotator cuff tears of the shoulder with poor tendon and muscle quality often cannot be fully repaired back to its footprint, and they have a high risk of re-tear. This study evaluates a combined technique for these tears.
During surgery, the torn rotator cuff is repaired as far as possible, the long head of the biceps tendon is transposed (rerouted) and fixed to the top of the humeral head, and the repair is augmented with an acellular dermal matrix graft (MegaDerm Plus, L\&C Bio, Republic of Korea). All participants receive the same operation and the same structured rehabilitation program; there is no comparison group.
Forty adults aged 40 to 75 years treated at Tam Anh General Hospital, Ho Chi Minh City, Vietnam, will be followed for 12 months after surgery. The main outcome is the rate of tendon retear on MRI at 12 months. Pain, shoulder function scores (Constant, ASES, UCLA), range of motion, muscle strength, X-ray findings and complications, including graft-related complications, will also be recorded.
Background and rationale:
Large-to-massive posterosuperior rotator cuff tears with severe fatty infiltration, muscle atrophy or tendon retraction often allow only incomplete repair, and retear rates after repair remain high. Two augmentation strategies have been described separately: partial superior capsule reconstruction using the rerouted long head of the biceps tendon (LHBT), and patch augmentation with an acellular dermal matrix (ADM). Direct clinical evidence for the combination of the two techniques is not yet available; the rationale of this study is based on indirect evidence from each component technique.
Design:
Prospective, single-center, single-arm case series (level of evidence IV) conducted at Tam Anh General Hospital, Ho Chi Minh City, as the clinical component of a doctoral dissertation at Hue University of Medicine and Pharmacy. A separate cadaveric biomechanical study within the same dissertation does not involve human participants and is not part of this registration.
Eligibility is assessed in two steps. Preoperative criteria are assessed clinically and on MRI. Intraoperative criteria (tear size, footprint coverage after maximal repair, and suitability of the LHBT for transposition) are confirmed arthroscopically. Participants who consented but do not meet the intraoperative criteria receive the most appropriate alternative procedure, are informed after surgery, and are not included in the analysis.
Intervention:
The surgery under general anesthesia combined with interscalene block, in the lateral decubitus position, and is performed by a single surgeon (H.V.D.A). After release of adhesions and footprint preparation, the LHBT is released from the bicipital groove and fixed to the superior greater tuberosity with a suture anchor. The rotator cuff is repaired with medial-row anchors (margin convergence and footprint medialization up to 10 mm when needed). An ADM graft (MegaDerm Plus, L\&C Bio; 2 mm thick; sized intraoperatively) is passed over the repair on the medial-row sutures and fixed laterally with a suture-bridge configuration using knotless lateral-row anchors.
MegaDerm Plus is registered in Vietnam as a Class D medical device (registration certificate No. 2501939ĐKLH/BYT-HTTB, issued 06 June 2025) and is used within its registered clinical use.
All participants follow the same phased postoperative rehabilitation protocol with defined criteria for progression between phases.
Follow-up and assessments:
Clinical assessments (VAS pain, Constant-Murley, ASES and UCLA scores, range of motion and shoulder strength) are performed preoperatively and at 3, 6 and 12 months after surgery. Radiographs are taken pre-operatovely and at 3 months to measure the acromiohumeral distance. MRI is performed preoperatively and at 3 and 12 months postoperatively. Tendon integrity is graded with the Sugaya classification; Sugaya type IV or V is defined as retear. MRI measurements are read independently by two radiologists, and inter-observer agreement is reported (kappa/ICC). Adverse events, including graft-related adverse events, are monitored throughout the 12-month follow-up.
Sample size and statistical analysis:
The study is descriptive and is not powered for a comparison with historical controls. The sample size was chosen to estimate the retear rate with acceptable precision: with 33 evaluable participants and no observed retear, the upper limit of the 95% confidence interval (rule of three) would be about 9%. Allowing approximately 10-15% loss to follow-up, 40 participants will be enrolled. The retear rate is reported as a proportion with its 95% confidence interval. Pre- and postoperative clinical scores are compared with paired t-tests or Wilcoxon signed-rank tests. Factors associated with retear and functional improvement (age, sex, tear size, Goutallier grade, RoHI score) are explored with linear or logistic regression. Analyses are performed in IBM SPSS with p \< 0.05 considered significant.
Ethics:
The protocol was approved by the Ethics Committee in Biomedical Research of Tam Anh General Hospital, Ho Chi Minh City (study code HV.26.09) and by the Ethics Committee of Hue University of Medicine and Pharmacy. Written informed consent is obtained from all participants. The study follows the Declaration of Helsinki and Good Clinical Practice.
745 studies on the registry are indexed under Rotator Cuff Injuries; 163 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 547 interventional studies indexed under Rotator Cuff Injuries.
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Preoperative:
Intraoperative (all required for inclusion in the analysis):
Exclusion Criteria:
Preoperative:
Intraoperative:
Participants who consented but meet an intraoperative exclusion criterion receive the most appropriate alternative procedure, are informed after surgery, and are not included in the analysis.
Arthroscopic incomplete repair of large-to-massive posterosuperior rotator cuff tears combined with long head of the biceps tendon transposition and acellular dermal matrix augmentation, followed by a standardized phased rehabilitation program.
Procedure: Rotator Cuff Repair · Procedure: Long Head of the Biceps Tendon Transposition · Device: Acellular Dermal Matrix (Allograft) Augmentation
Arthroscopic repair of the posterosuperior rotator cuff to the maximum achievable footprint coverage after release of adhesions, using double-loaded medial-row suture anchors, with margin convergence and footprint medialization (up to 10 mm) when needed.
The long head of the biceps tendon is released from the bicipital groove, transposed to the superior greater tuberosity and fixed with a double-loaded suture anchor placed 5 mm lateral to the articular margin, using two lasso-loop stitches.
Also known as: Biceps rerouting; LHBT transposition, Biceps superior capsule reconstruction; LHBT superior capsule reconstruction; LHBT SCR
A 2-mm-thick acellular dermal matrix graft, sized intraoperatively, is passed over the repair on the medial-row sutures and fixed laterally in a suture-bridge configuration with knotless lateral-row anchors. The device is registered in Vietnam as a Class D medical device (No. 2501939ĐKLH/BYT-HTTB).
Also known as: MegaDerm Plus (L&C Bio, Republic of Korea)
Rotator Cuff Retear Rate on MRI
Proportion of participants with retear, defined as Sugaya type IV or V on postoperative MRI (T2-weighted), read independently by two radiologists blinded to clinical outcome scores; disagreements resolved by consensus or third-reader adjudication. Reported as a percentage with 95% confidence interval.
Time frame: 12 months after surgery
Tendon Integrity (Sugaya Classification) on MRI
Distribution of Sugaya types I-V (I = best integrity, V = major discontinuity) on postoperative MRI, read independently by two radiologists.
Time frame: 3 months and 12 months after surgery
Pain Intensity (Visual Analog Scale)
VAS pain score from 0 (no pain) to 10 (worst imaginable pain).
Time frame: Preoperative (baseline), 3, 6 and 12 months after surgery
Constant-Murley Score
Shoulder function score from 0 to 100; higher scores indicate better function.
Time frame: Preoperative (baseline), 3, 6 and 12 months after surgery
American Shoulder and Elbow Surgeons (ASES) Score
Score from 0 to 100 combining pain and activities of daily living; higher scores indicate better function.
Time frame: Preoperative (baseline), 3, 6 and 12 months after surgery
UCLA Shoulder Score
Score from 0 to 35; higher scores indicate better shoulder function.
Time frame: Preoperative (baseline), 3, 6 and 12 months after surgery
Shoulder Range of Motion
Active and passive forward elevation, external rotation and external rotation at 90° abduction (degrees, goniometer); internal rotation recorded as the highest vertebral level reached by the thumb.
Time frame: Preoperative (baseline), 3, 6 and 12 months after surgery
Shoulder Abduction Strength
Manual muscle testing (MRC grade 0-5) and hand-held dynamometer (Newtons), measured with the shoulder abducted, thumb up and elbow extended
Time frame: Preoperative (baseline), 3, 6 and 12 months after surgery
Acromiohumeral Distance on Radiograph
Shortest distance (mm) between the undersurface of the acromion and the superior humeral head on an anteroposterior shoulder radiograph
Time frame: Pre-operative and at 3 months after surgery
Adverse Events, Including Graft-Related Adverse Events
Number of participants with adverse events, including wound complications, infection, nerve or vessel injury, sterile inflammatory reaction, graft rejection or foreign-body reaction, and reoperation; relationship to the device is assessed for each event
Time frame: From surgery to 12 months after surgery
Integrity of the Transposed Long Head of the Biceps Tendon on MRI
Continuity of the transposed LHBT between the supraglenoid origin and the anchor fixation on the greater tuberosity on postoperative MRI, classified as intact or discontinuous (rupture or detachment), read independently by two radiologists.
Time frame: 3 months and 12 months after surgery
Plan to share: No — Individual participant data will not be shared. The informed consent restricts data access to the research team, the Ethics Committee and regulatory authorities, and states that results will be published only in aggregate form.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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