The Effect of Arthroscopic Subacromial Decompression in Patients Who Are Non-responders to Non-operative Treatment.
The Effect of Arthroscopic Subacromial Decompression in Patients With Subacromial Impingement Syndrome Who Are Non-responders to Non-operative Treatment. A Double-blinded, Randomized, Controlled Trial.
Hvidovre University Hospital
160 participants
Sep 1, 2021
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria8
- 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.
- Symptoms for at least 6 months
- Completion of at least 3 months supervised shoulder training
- No improvement in symptoms for at least 3 months
- The patient must be expected to be able to attend rehabilitation and post-examinations.
Exclusion Criteria5
- 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
- Ongoing workers compensation case or job rehabilitation process
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Interventions
In 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 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.
Locations(1)
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NCT04644042