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NCT Number: NCT04644042

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

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.

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Key information

Conditions

Subacromial Impingement Syndrome Joint Diseases Musculoskeletal Diseases Shoulder Impingement Syndrome Shoulder Injuries Wounds and Injuries

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hvidovre Univeristy Hospital

Hvidovre, Denmark, 2650

Location status: Recruiting

Location contact

Adam Witten, MD

CONTACT

[email protected]

28780809

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 + 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.

Primary outcomes

  1. Shoulder Pain and Disability Index (SPADI)

    Time frame: 12 months after surgical intervention.

    The primary outcome is SPADI 12 months after surgical intervention.

Secondary outcomes

  1. Shoulder Pain and Disability Index (SPADI)

    Time frame: 24 months

    SPADI is registered as a secondary outcome 3, 6 and 24 months after surgical intervention.

  2. Oxford Shoulder Score

    Time frame: 24 months

    Oxford Shoulder Score is registered 3, 6, 12 and 24 months after surgical intervention.

  3. Patient Satisfaction

    Time frame: 12 months

    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).

  4. Active Shoulder Abduction Range Of Motion (AROM)

    Time frame: 12 months

    Active Shoulder Abduction Range Of Motion is registered at 3 and 12 months after surgical intervention.

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

    Time frame: 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Adam Witten, MD

CONTACT

[email protected]

004528780809

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study 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.

Acronym: SELECT

Important dates

Study start
2021
Primary completion
2028
Study completion
2029
First posted
Nov 25, 2020
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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