Clinical Trial to Compare Clinical and Functional Results of the Augmentation of Supraspinatus Tears With the Long Head of the Biceps Brachii Tendon
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Augmented supraspinatus repair, Convencional Supraspinatus tear repair.
- Who it may be relevant to
- Registry conditions: Rotator Cuff Tear Surgical Repair. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Use of Long Head of bíceps Brachii Tendon as an Augmentation for Supraspinatus Tears: a Comparative Clinical Trial.
Overview
The goal of this clinical trial is to reduce the risk for re-tear in rotator cuff surgeries and improve clinical results in a working age population. The main questions it aims to answer are: If we can improve surgical results using the long head of the biceps tendon as a graft. If we can reduce the risk of re-tear using the long head of the biceps tendon as a graft. Researchers will compare participants with rotator cuff tears with two different surgical techniques to see if their clinical results improve using the long head of the biceps tendon as a graft compared with not using a graft. Participants will be asked to get enrolled in the study not knowing in which group they will be assigned to by signing a Informed Consent Form and both groups would have the same follow up conditions and treatment.
Interventions
- Procedure Augmented supraspinatus repair
After conventional arthroscopic repair of the supraspinsatus with a double row technique, an autologous graft obtained from the long head of the biceps will be used as a Graf to improve biological properties of the supraspinatus tear; aiming to reduce re-tears and to improve Clinical results. - Procedure Convencional Supraspinatus tear repair
A double row technique will be performed arthroscopically.
Primary outcome measures
- Constant Murley Score [Time frame: From enrollment to the end of follow up at 1 year after surgery]
Secondary outcome measures (6)
- ASES score [Time frame: From enrollment to 1 year after surgery]
- VAS [Time frame: From enrollment to 1 year after surgery]
- Range of Motion [Time frame: From enrollment to 1 year after surgery]
- Strenght in abduction [Time frame: From enrollment to 1 year after surgery]
- Re-tear rate [Time frame: From enrollment to 1 year after surgery]
- Satisfaction index [Time frame: From enrollment to 1 year after surgery]
Eligibility criteria
Inclusion criteria
- Active workers.
- A supraspinatus tear diagnosed in MRI.
- Modified Rohi equal or over 5 points.
- Failed conservative treatment (at least 3 months of phisiotherapy) or surgical indication secondary to acute traumatic tear with severe functional limitation.
- Age between 18 and 65.
- Long head of the biceps tendon pathology.
- Able to understand and sign the Informed Consent Form.
Exclusion criteria
- Tear of the subscapularis or infraspinatus tendon.
- Supraspinatus tears <1cm.
- Lack of long head of the biceps tendon.
- Rotator Cuff Arthropathy (Hamada >3).
- Glenohumeral osteoarthritis.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07657689 · 23/654-E_Tesis