Rotator Cuff InjuriesNCT06664645
Rotator Cuff Tears Treated With Long Head of the Biceps Reinforcement
A study testing LHB tendon reinforcement and complete repair without reinforcement in people with Rotator Cuff Injuries and Biceps Tendon Reattachment, run by Hospital Universitario Pedro Ernesto at 1 site in Brazil.
Trial summary
The increase of the population life expectancy and the active lifestyle adopted in recent years have contributed to the higher incidence of rotator cuff injuries. For large (>3 cm) and extensive (>5 cm) injuries of the rotator cuff, even after complete or partial repair, the chances of failure reach 94%. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rotator Cuff Injuries, Biceps Tendon Reattachment
- What is being tested?
- LHB tendon reinforcement and complete repair without reinforcement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Jan 2022to 14 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Long head tendon of biceps intact;
- Large or extensive posterosuperior rotator cuff injuries according to the classification of DeOrio and Cofield;20
- Fatty degeneration of the ≦2 supraspinatus muscle according to the classification of Goutallier.21
Who cannot join
- Active or previous infection in the affected shoulder;
- Patients unable to understand preoperative questionnaires;
- Patient who does not undergo at least 1 postoperative evaluation.
- Injury where complete repair of the rotator cuff is not possible;
- Rupture of the LHB tendon diagnosed intraoperatively.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
hospital Universitário Pedro Ernesto
Rio de Janeiro, Rio de Janeiro, 20551-030
About this study
Official title: Evaluation of Rotator Cuff Repair With Long Head of the Biceps Reinforcement: a Prospective Randomized Study
The increase of the population life expectancy and the active lifestyle adopted in recent years have contributed to the higher incidence of rotator cuff injuries. For large (>3 cm) and extensive (>5 cm) injuries of the rotator cuff, even after complete or partial repair, the chances of failure reach 94%.
An alternative in rotator cuff injuries is the use of the long head of the biceps (LHB) as an autologous graft to increase the healing rate and the final outcomes.
Read more
The primary objective is to compare the functional results, according to the ASES score, between patients who use or not the long head biceps brace for complete repairs of large and extensive rotator cuff tears.
The secondary objectives are to compare the groups according to structural results by MRI and functional results by the UCLA score.
Read the detailed description
A prospective randomized study will be carried out in a 1:1 ratio between groups. Patients with large and extensive rotator cuff injuries will be selected at the Shoulder and Elbow clinic of Pedro Ernesto University Hospital (HUPE-UERJ), during outpatient care.
Patients with an intact long head of the biceps will be randomized into two groups, according to the use or not of the tendon: complete repair with LHB tendon reinforcement and complete repair without reinforcement. All patients will be operated by the same surgeon.
All selected patients will be explained what the research is about by a research assistant not involved in the treatment and will be offered the option to participate or not.
The "American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form" (ASES) scale will be adopted as the primary outcome. The "Modified University of California at Los Angeles Shoulder Rating Scale" (UCLA) and the assessment of tendon healing with magnetic resonance imaging at 6 months after surgery, using the classification of Sugaya et al. will be secondary outcomes.
- Conditions
- Rotator Cuff Injuries, Biceps Tendon Reattachment
- Being tested
- LHB tendon reinforcement, complete repair without reinforcement
- Keywords
- rotator cuff, tendon transfer, biceps reinforcement, biceps autograft
- 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.
LHB tendon reinforcementProcedure or surgery
complete repair with LHB tendon reinforcement
complete repair without reinforcementProcedure or surgery
conventional rotator cuff complete repair without reinforcement
| Study group | Role | What they receive |
|---|---|---|
| complete repair with LHB tendon reinforcement | Experimental | complete repair with LHB tendon reinforcement Receives: Procedure: LHB tendon reinforcement |
| complete repair without reinforcement | Active comparator | complete repair without reinforcement. Receives: Procedure: complete repair without reinforcement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue score (VAS)
Visual analogue score: it is a 10 cm line with two end points, one representing "no pain" and the other representing "worst pain". The patient marks the line to indicate their current pain level, and the distance from the "no pain" marker to the mark is measured in centimeters to provide a score. A higher score indicates greater pain intensity.
Measured: 24 months
Structural outcomes
Patients will undergo preoperative MRI and from 6 months after the procedure. All images will be evaluated by at least two authors of the work, who will not know which group the patients belong to.
The classification by Sugaya et al. stratifies the appearance of the tendon after repair into 5 types: type I (sufficient thickness with low signal in all images); type II (sufficiently thick with high focal signal); type III (insufficient thickness without discontinuity); type IV (small size tear) and type V (medium or large size tear).
The healing of the long head biceps reinforcement will also be evaluated by MRI and classified as unhealed and healed.
Measured: 24 months
American Shoulder and Elbow Score (ASES)
American Shoulder and Elbow Score score ranges from 0 to 100, with 0 the lowest level of function and 100 the highest level of function.
Measured: 24
The University of California-Los Angeles (UCLA)
Scores ranged from 0 to 35 with a score of 0 indicating worst shoulder function and 35 indicating best shoulder function.
Measured: 24 months
The 12 item Short Form Survey (SF-12)
This is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.
Utilize the norm-based scoring system to interpret Physical component and Mental component scores, with a mean of 50 and a standard deviation of 10 in the general population. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start14 Jan 2022
- Primary completion14 Apr 2025
- Study completion14 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff InjuriesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective randomized study will be carried out in a 1:1 ratio between groups. Patients with large and extensive rotator cuff injuries will be selected at the Shoulder and Elbow clinic of Pedro Ernesto University Hospital (HUPE-UERJ), during outpatient care. Patients with an intact long head of the biceps will be randomized into two groups, according to the use or not of the tendon: complete repair with LHB tendon reinforcement and complete repair without reinforcement.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Pedro Ernesto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GUSTAVO DE MELLO RIBEIRO PINTO, Hospital Universitario Pedro Ernesto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664645
- Sponsor's protocol ID
- 53239121.4.0000.5259
- Status last verified
- Jun 2025
- First submitted
- 11 Oct 2024
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barth J, Olmos MI, Swan J, Barthelemy R, Delsol P, Boutsiadis A. Superior Capsular Reconstruction With the Long Head of the Biceps Autograft Prevents Infraspinatus Retear in Massive Posterosuperior Retracted Rotator Cuff Tears. Am J Sports Med. 2020 May;48(6):1430-1438. doi: 10.1177/0363546520912220. Epub 2020 Apr 8.
PubMed 32267730Rhee SM, Youn SM, Park JH, Rhee YG. Biceps Rerouting for Semirigid Large-to-Massive Rotator Cuff Tears. Arthroscopy. 2021 Sep;37(9):2769-2779. doi: 10.1016/j.arthro.2021.04.008. Epub 2021 Apr 20.
PubMed 33892075Cho NS, Yi JW, Rhee YG. Arthroscopic biceps augmentation for avoiding undue tension in repair of massive rotator cuff tears. Arthroscopy. 2009 Feb;25(2):183-91. doi: 10.1016/j.arthro.2008.09.012. Epub 2008 Nov 1.
PubMed 19171279
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Rotator Cuff Repair With Long Head of the Biceps Reinforcement: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT06664645
- Acronym / sponsor ID
- 53239121.4.0000.5259
- Conditions
- Rotator Cuff Injuries, Biceps Tendon Reattachment
- Keywords
- rotator cuff, tendon transfer, biceps reinforcement, biceps autograft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital Universitario Pedro ErnestoUniversity, hospital or other
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 14 Apr 2025 (actual)
- Study completion
- 14 Apr 2025 (actual)
- First posted
- 29 Oct 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.
The increase of the population life expectancy and the active lifestyle adopted in recent years have contributed to the higher incidence of rotator cuff injuries. For large (>3 cm) and extensive (>5 cm) injuries of the rotator cuff, even after complete or partial repair, the chances of failure reach 94%.
An alternative in rotator cuff injuries is the use of the long head of the biceps (LHB) as an autologous graft to increase the healing rate and the final outcomes.
The primary objective is to compare the functional results, according to the ASES score, between patients who use or not the long head biceps brace for complete repairs of large and extensive rotator cuff tears.
The secondary objectives are to compare the groups according to structural results by MRI and functional results by the UCLA score.
Detailed description
A prospective randomized study will be carried out in a 1:1 ratio between groups. Patients with large and extensive rotator cuff injuries will be selected at the Shoulder and Elbow clinic of Pedro Ernesto University Hospital (HUPE-UERJ), during outpatient care.
Patients with an intact long head of the biceps will be randomized into two groups, according to the use or not of the tendon: complete repair with LHB tendon reinforcement and complete repair without reinforcement. All patients will be operated by the same surgeon.
All selected patients will be explained what the research is about by a research assistant not involved in the treatment and will be offered the option to participate or not.
The "American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form" (ASES) scale will be adopted as the primary outcome. The "Modified University of California at Los Angeles Shoulder Rating Scale" (UCLA) and the assessment of tendon healing with magnetic resonance imaging at 6 months after surgery, using the classification of Sugaya et al. will be secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective randomized study will be carried out in a 1:1 ratio between groups. Patients with large and extensive rotator cuff injuries will be selected at the Shoulder and Elbow clinic of Pedro Ernesto University Hospital (HUPE-UERJ), during outpatient care. Patients with an intact long head of the biceps will be randomized into two groups, according to the use or not of the tendon: complete repair with LHB tendon reinforcement and complete repair without reinforcement.
| Arm | Type | Receives |
|---|---|---|
| complete repair with LHB tendon reinforcement | Experimental | Procedure: LHB tendon reinforcementcomplete repair with LHB tendon reinforcement |
| complete repair without reinforcement | Active comparator | Procedure: complete repair without reinforcementcomplete repair without reinforcement. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Long head tendon of biceps intact;
- Large or extensive posterosuperior rotator cuff injuries according to the classification of DeOrio and Cofield;20
- Fatty degeneration of the ≦2 supraspinatus muscle according to the classification of Goutallier.21
Key exclusion criteria (5 listed)
- Active or previous infection in the affected shoulder;
- Patients unable to understand preoperative questionnaires;
- Patient who does not undergo at least 1 postoperative evaluation.
- Injury where complete repair of the rotator cuff is not possible;
- Rupture of the LHB tendon diagnosed intraoperatively.
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 |
|---|---|---|
| LHB tendon reinforcementcomplete repair with LHB tendon reinforcement | Procedure or surgery | complete repair with LHB tendon reinforcement |
| complete repair without reinforcementconventional rotator cuff complete repair without reinforcement | Procedure or surgery | complete repair without reinforcement |
Primary outcome
Visual analogue score (VAS)
Time frame: 24 months
Visual analogue score: it is a 10 cm line with two end points, one representing "no pain" and the other representing "worst pain". The patient marks the line to indicate their current pain level, and the distance from the "no pain" marker to the mark is measured in centimeters to provide a score. A higher score indicates greater pain intensity.
Structural outcomes
Time frame: 24 months
Patients will undergo preoperative MRI and from 6 months after the procedure. All images will be evaluated by at least two authors of the work, who will not know which group the patients belong to. The classification by Sugaya et al. stratifies the appearance of the tendon after repair into 5 types: type I (sufficient thickness with low signal in all images); type II (sufficiently thick with high focal signal); type III (insufficient thickness without discontinuity); type IV (small size tear) and type V (medium or large size tear). The healing of the long head biceps reinforcement will also be evaluated by MRI and classified as unhealed and healed.
American Shoulder and Elbow Score (ASES)
Time frame: 24
American Shoulder and Elbow Score score ranges from 0 to 100, with 0 the lowest level of function and 100 the highest level of function.
The University of California-Los Angeles (UCLA)
Time frame: 24 months
Scores ranged from 0 to 35 with a score of 0 indicating worst shoulder function and 35 indicating best shoulder function.
The 12 item Short Form Survey (SF-12)
Time frame: 24 months
This is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. Utilize the norm-based scoring system to interpret Physical component and Mental component scores, with a mean of 50 and a standard deviation of 10 in the general population. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Results publication: PubMed 32267730Barth J, Olmos MI, Swan J, Barthelemy R, Delsol P, Boutsiadis A. Superior Capsular Reconstruction With the Long Head of the Biceps Autograft Prevents Infraspinatus Retear in Massive Posterosuperior Retracted Rotator Cuff Tears. Am J Sports Med. 2020 May;48(6):1430-1438. doi: 10.1177/0363546520912220. Epub 2020 Apr 8.
- Results publication: PubMed 33892075Rhee SM, Youn SM, Park JH, Rhee YG. Biceps Rerouting for Semirigid Large-to-Massive Rotator Cuff Tears. Arthroscopy. 2021 Sep;37(9):2769-2779. doi: 10.1016/j.arthro.2021.04.008. Epub 2021 Apr 20.
- Results publication: PubMed 19171279Cho NS, Yi JW, Rhee YG. Arthroscopic biceps augmentation for avoiding undue tension in repair of massive rotator cuff tears. Arthroscopy. 2009 Feb;25(2):183-91. doi: 10.1016/j.arthro.2008.09.012. Epub 2008 Nov 1.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LHB tendon reinforcement and complete repair without reinforcement in people with Rotator Cuff Injuries and Biceps Tendon Reattachment, run by Hospital Universitario Pedro Ernesto at 1 site in Brazil.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue score (VAS) (time frame: 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06664645, which also lists 3 linked publications.
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 26 Jun 2025.