Massive rotator cuff tears are common in the adult population. It is estimated that about 12 % of adults 60 years of age or older suffer from a rotator cuff injury. About 40 % of these injuries are classified as massive rotator cuff tears (MRCT). MRCT propose a great challenge to the affected patient and its doctor. It is a painful condition with few treatment options.
The study aims to investigate the operative treatment for MRCT with the new treatment option proposed by Senecovic. Insertion of a biodegradable balloon as a subacromial spacer has proven promising results so far. To this date there is only small and non-randomized studies on the subject. AMRIS are planning to do a randomized controlled study where group A is treated with arthroscopic debridement, biceps tenotomy and biodegradable spacer, while group B, the control group are treated with arthroscopic debridement and biceps tenotomy.
Patients suffering from a symptomatic massive rotator cuff tear, with fatty infiltration grade 3 or 4 classified on CT by Goutallier et al, or MRI by Fuchs classification.
Persistent pain for at least 3 months, with documented failure of conservative treatment
Age ranging from 60 years of age to 85 years of age
Significant shoulder osteoarthritis in the affected shoulder, Hamada classification >2.
Total rupture of subscapularis tendon and/or teres minor, classified B and E in the Collins classification.
Comorbidity to the degree that the patient will not be able to participate in the follow up program.
Parallel
Biodegradable spacer
Procedure/SurgeryImplantation of a biodegradable balloon used as a subacromial spacer.
Debridement and biceps tenotomy
Procedure/SurgerySurgery with arthroscopic debridement and biceps tenotomy
Change in Constant score
A well review score that takes several factors in to account: active range of motion, activities of daily living, pain and strength. A person with a normal, healthy shoulder should score 100 points, which is maximum score. Constant score is seen as a relatively objective test, as the testing will be performed by a physiotherapist.
WORC
Western Ontario Rotator Cuff Index is a questionnaire that explores 5 domains: physical symptoms, sports and recreation, work, social function, emotions.
X-ray of the shoulder
Measure the height from the head of the humerus to the acromion
VAS
Visual analog scale for pain in rest, activity and at night. Scale from 0 til 10.
Eq-5D
Questionaire for daily activity
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