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

NCT04644042 | Recruiting DMC

• 1 other identifier: SELECT trial
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Subacromial Impingement Syndrome

Outcome Measures

Primary Outcomes (1)

• Shoulder Pain and Disability Index (SPADI)

  The primary outcome is SPADI 12 months after surgical intervention.

  12 months after surgical intervention.

Secondary Outcomes (5)

• Shoulder Pain and Disability Index (SPADI)

  24 months

• Oxford Shoulder Score

  24 months

• Patient Satisfaction

  12 months

• Active Shoulder Abduction Range Of Motion (AROM)

  12 months

• Pain during Active Shoulder Abduction Range Of Motion (NPRS-AROM)

  12 months

Study Arms (2)

Glenohumeral arthroscopy and arthroscopic subacromial decompression

EXPERIMENTAL

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.

Procedure: Glenohumeral arthroscopy + Arthroscopic Subacromial Decompression

Glenohumeral arthroscopy and skin incision

ACTIVE COMPARATOR

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.

Procedure: Glenohumeral arthroscopy + lateral skin incision

Interventions

Glenohumeral arthroscopy + Arthroscopic Subacromial Decompression PROCEDURE

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 and arthroscopic subacromial decompression

Glenohumeral arthroscopy + lateral skin incision PROCEDURE

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.

Glenohumeral arthroscopy and skin incision

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Hvidovre Univeristy Hospital

Hvidovre, Denmark, 2650, Denmark

RECRUITING

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Study Officials

• Kristoffer Barfod, MD

  Sports Orthopedic Research Center - Copenhagen (SORC-C), Hvidovre Hospital

  STUDY DIRECTOR

Central Study Contacts

Adam Witten, MD

CONTACT

004528780809; adam.witten.02@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 25, 2020
• Study Start: September 1, 2021
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)