Rotator Cuff Tear Surgical Repair
Conditions
Keywords
Rotator cuff tear, Augmentation, Long head of the biceps, Graft, Supraspinatus tear, Rotator cuff disease, Rotator cuff surgical treatment, Compressed long head of the biceps, Constant Murley Score, Ases Score
Brief summary
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
PROCEDUREAugmented 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.
PROCEDUREConvencional Supraspinatus tear repair
A double row technique will be performed arthroscopically.
Sponsors
HOSPITAL FRATERNIDAD MUPRESPA HABANA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Constant Murley Score | From enrollment to the end of follow up at 1 year after surgery | Shoulder specific clinical Score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ASES score | From enrollment to 1 year after surgery | American Shoulder and Elbow Score |
| VAS | From enrollment to 1 year after surgery | Pain scale |
| Range of Motion | From enrollment to 1 year after surgery | Motion |
| Strenght in abduction | From enrollment to 1 year after surgery | — |
| Re-tear rate | From enrollment to 1 year after surgery | — |
| Satisfaction index | From enrollment to 1 year after surgery | PASS score |
Outcome results
None listed