RecruitingNot ApplicableNCT04644042

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.


Sponsor

Hvidovre University Hospital

Enrollment

160 participants

Start Date

Sep 1, 2021

Study Type

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

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether arthroscopic subacromial decompression surgery — a minimally invasive procedure that removes bone spurs or inflamed tissue from beneath the shoulder joint — actually helps patients with shoulder impingement syndrome (SIS) who have not responded to at least 3 months of supervised physiotherapy. Shoulder impingement occurs when tendons in the shoulder are pinched between bones, causing pain and limited movement. While surgery is commonly performed, its benefit over continued non-surgical management is still debated. Patients who have tried and failed conservative (non-surgical) treatment will be randomly assigned to either the surgery or a further non-surgical management approach. Researchers will track pain levels, shoulder function, and quality of life over time to determine whether surgery provides a meaningful benefit in this group of treatment-resistant patients. You may be eligible if: - You have a clinical diagnosis of shoulder impingement syndrome (SIS) - A subacromial injection has provided at least temporary pain relief - You have had shoulder symptoms for at least 6 months - You have completed at least 3 months of supervised shoulder physiotherapy with no meaningful improvement - You have been assessed as a surgical candidate by an orthopedic shoulder specialist You may NOT be eligible if: - You have a serious medical illness (ASA score 4 or higher), inflammatory joint disease, or systemic musculoskeletal disease - You have a full-thickness rotator cuff tear, frozen shoulder, calcified tendonitis, or other shoulder pathology - You have had previous surgery or radiotherapy on the affected shoulder - You are pregnant - You have an ongoing workers' compensation or job rehabilitation case Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREGlenohumeral 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.

PROCEDUREGlenohumeral 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 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)

Hvidovre Univeristy Hospital

Hvidovre, Denmark, Denmark

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04644042


Related Trials