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

Official title

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.

Overview

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.

Detailed 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.

Interventions

• Procedure Glenohumeral arthroscopy + Arthroscopic Subacromial Decompression
  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.
• Procedure Glenohumeral arthroscopy + lateral skin incision
  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 in

Primary outcome measures

• Shoulder Pain and Disability Index (SPADI) [Time frame: 12 months after surgical intervention.]

Secondary outcome measures (5)

• Shoulder Pain and Disability Index (SPADI) [Time frame: 24 months]
• Oxford Shoulder Score [Time frame: 24 months]
• Patient Satisfaction [Time frame: 12 months]
• Active Shoulder Abduction Range Of Motion (AROM) [Time frame: 12 months]
• Pain during Active Shoulder Abduction Range Of Motion (NPRS-AROM) [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Denmark · 1 center

• Hvidovre Univeristy Hospital — Hvidovre

Identifiers

NCT: NCT04644042 · SELECT trial

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗