The Effect of Arthroscopic Subacromial Decompression in Patients Who Are Non-responders to Non-operative Treatment. (SELECT)

Hvidovre University Hospital

Status: Enrolling

Conditions: Subacromial Impingement Syndrome

Treatments: Procedure: Glenohumeral arthroscopy + lateral skin incision; Procedure: Glenohumeral arthroscopy + Arthroscopic Subacromial Decompression

Study type: Interventional

Funder types: Other

Identifiers

NCT04644042

SELECT trial

Details and patient eligibility

About

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.

Full description

The trial is designed as a patient and assessor-blinded, randomized, controlled trial with two parallel groups. Participants are randomized 1:1 to either ASAD and glenohumeral arthroscopy (intervention group) or glenohumeral arthroscopy alone (control group). The two groups are subscribed identical postoperative rehabilitation consisting of 3 months physiotherapy in a municipally setting. The primary endpoint is the Shoulder Pain and Disability Index (SPADI) 12 months after surgical intervention. The study will adhere to the CONSORT guidelines.

All participants will be recruited consecutively from the outpatient clinic, Arthroscopic Center, Copenhagen University Hospital, Hvidovre. Consultant orthopedic surgeons will conduct the initial eligibility screening as part of their consultation. Eligible participants will be provided with thorough verbal and written information about the trial and their right to withdraw at any time. Patients given their written, informed consent to participate in the trial, will receive scheduled appointments for the baseline examination.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups

Glenohumeral arthroscopy and arthroscopic subacromial decompression

Experimental group

Description:

The intervention group will receive a glenohumeral arthroscopy and ASAD. Participants are discharged with an arm sling and referred to 3 months physiotherapy in a municipally setting. Participants are given a rehabilitation program containing progressive exercises to guide the rehabilitation.

Treatment:

Procedure: Glenohumeral arthroscopy + Arthroscopic Subacromial Decompression

Glenohumeral arthroscopy and skin incision

Active Comparator group

Description:

The control group will receive a glenohumeral arthroscopy, but no treatment concerning the subacromial structures. To allow for the best possible blinding, a 7-10 mm incision, mimicking the one used for ASAD, is performed on the lateral side of the arm 2-3 distal to the acromion. Participants are discharged with an arm sling and referred to 3 months physiotherapy in a municipally setting. Participants are given a rehabilitation program containing progressive exercises to guide the rehabilitation.

Treatment:

Procedure: Glenohumeral arthroscopy + lateral skin incision