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

Subacromial Impingement Syndrome Clinical Trial

— SELECT  

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT04644042
• Other study ID #: SELECT trial
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: June 1, 2026

Study information

• Verified date: May 2023
• Source: Hvidovre University Hospital
• Contact: Adam Witten, MD
• Phone: 004528780809
• Email: adam.witten.02[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: June 1, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Impingement Syndrome
• Subacromial Impingement Syndrome
• Syndrome

Intervention

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.
• 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 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

Country	Name	City	State
Denmark	Hvidovre Univeristy Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder Pain and Disability Index (SPADI)	The primary outcome is SPADI 12 months after surgical intervention.	12 months after surgical intervention.
Secondary	Shoulder Pain and Disability Index (SPADI)	SPADI is registered as a secondary outcome 3, 6 and 24 months after surgical intervention.	24 months
Secondary	Oxford Shoulder Score	Oxford Shoulder Score is registered 3, 6, 12 and 24 months after surgical intervention.	24 months
Secondary	Patient Satisfaction	Patient satisfaction will be assessed using three questions: "How are the problems related to your shoulder now, compared with before surgery?" (response options: no problems at all, much better, slightly better, no change, slightly worse, much worse); "Overall, how pleased have you been with the result of your surgery so far?" (response options: very pleased, fairly pleased, not very pleased, very disappointed); "If you could go back in time, would you still choose to have the shoulder operation?" (response options: yes, no, not sure).	12 months
Secondary	Active Shoulder Abduction Range Of Motion (AROM)	Active Shoulder Abduction Range Of Motion is registered at 3 and 12 months after surgical intervention.	12 months
Secondary	Pain during Active Shoulder Abduction Range Of Motion (NPRS-AROM)	Pain during active shoulder abduction range of motion is evaluated using the numeric pain rating scale (NPRS) at 3 and 12 months after surgical intervention.	12 months