To investigate if glenohumeral arthroscopy and arthroscopic subacromial decompression is more effective than glenohumeral arthroscopy alone in improving patient-reported outcome at 12 months in patients with subacromial impingement syndrome (SIS) who are non-responders to non-operative treatment.
SIS diagnosis (Consultant's clinical diagnosis of SIS + at least 3 out of 5 positive tests from the following: Hawkin's, Neer's, Jobe's, Painful arc and external rotation resistance test)
Positive subacromial injection test
Insidious onset of shoulder pain
Considered a surgical candidate by an orthopedic shoulder specialist.
Terminal illness or severe medical illness (ASA score higher than or equal to 4), systemic musculoskeletal disease, inflammatory joint disease (e.g. rheumatoid arthritis), symptomatic cervical spine pathology or thoracic outlet syndrome.
Full-thickness rotator cuff tear, calcified tendonitis, labral tear, frozen shoulder, biceps tendon pathology, acromioclavicular osteoarthrosis, glenohumeral osteoarthrosis or other concomitant shoulder pathology.
Previous surgery or radiotherapy on the affected shoulder.
Pregnancy
Parallel
Glenohumeral arthroscopy + Arthroscopic Subacromial Decompression
Procedure/SurgeryIn addition to the glenohumeral athroscopy a lateral portal will be used to access the subacromial space. The subacromial space will be decompressed with removal of inflamed bursal tissue and acromioclavicular osteophytes, release of the coracoacromial ligament, and, if deemed necessary by the surgeon, acromioplasty performed ad modum Caspari.
Glenohumeral arthroscopy + lateral skin incision
Procedure/SurgeryGlenohumeral arthroscopy is performed as a standard investigational procedure. The patient is put under general anesthesia and positioned in the 'beach chair position'. An anteriorsuperior portal and a posterior mid-glenoid portal are used as entry to the joint. The following structures are investigated as a minimum: the articular surface of the humeral head and the glenoid, labrum, the long biceps tendon and its attachment at the superior labrum, the undersurface of the supraspinatus and the infraspinatus tendon, the subscapularis tendon and the glenohumeral ligaments. To allow for the best possible blinding a skin incision (mimicking the one used for arthroscopic subacromial decompression) is performed on the lateral side of the shoulder of the participants in the control group. The obturator is introduced in the subcutaneous tissue and a slight circular release is performed. The deltoid fascia is not perforated and the subacromial space is not entered.
Shoulder Pain and Disability Index (SPADI)
The primary outcome is SPADI 12 months after surgical intervention.
Shoulder Pain and Disability Index (SPADI)
SPADI is registered as a secondary outcome 3, 6 and 24 months after surgical intervention.
Oxford Shoulder Score
Oxford Shoulder Score is registered 3, 6, 12 and 24 months after surgical intervention.
Patient Satisfaction
Patient satisfaction will be assessed using three questions: 1. "How are the problems related to your shoulder now, compared with before surgery?" (response options: no problems at all, much better, slightly better, no change, slightly worse, much worse) 2. "Overall, how pleased have you been with the result of your surgery so far?" (response options: very pleased, fairly pleased, not very pleased, very disappointed) 3. "If you could go back in time, would you still choose to have the shoulder operation?" (response options: yes, no, not sure).
Active Shoulder Abduction Range Of Motion (AROM)
Active Shoulder Abduction Range Of Motion is registered at 3 and 12 months after surgical intervention.
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