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

Subacromial Impingement Syndrome Clinical Trial

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.

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04644042
Study type Interventional
Source Hvidovre University Hospital
Contact Adam Witten, MD
Phone 004528780809
Email adam.witten.02@regionh.dk
Status Recruiting
Phase N/A
Start date September 1, 2021
Completion date June 1, 2026
View Details
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