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

Primary Purpose

Subacromial Impingement Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Glenohumeral arthroscopy + Arthroscopic Subacromial Decompression
Glenohumeral arthroscopy + lateral skin incision
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacromial Impingement Syndrome

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • Diabetes mellitus
  • Ongoing workers compensation case or job rehabilitation process

Sites / Locations

  • Hvidovre Univeristy HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Glenohumeral arthroscopy and arthroscopic subacromial decompression

Glenohumeral arthroscopy and skin incision

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Shoulder Pain and Disability Index (SPADI)
The primary outcome is SPADI 12 months after surgical intervention.

Secondary Outcome Measures

Shoulder Pain and Disability Index (SPADI)
SPADI is registered as a secondary outcome 3, 6 and 24 months after surgical intervention.
Oxford Shoulder Score
Oxford Shoulder Score is registered 3, 6, 12 and 24 months after surgical intervention.
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).
Active Shoulder Abduction Range Of Motion (AROM)
Active Shoulder Abduction Range Of Motion is registered at 3 and 12 months after surgical intervention.
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.

Full Information

First Posted
November 19, 2020
Last Updated
May 4, 2023
Sponsor
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04644042
Brief Title
The Effect of Arthroscopic Subacromial Decompression in Patients Who Are Non-responders to Non-operative Treatment.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Glenohumeral arthroscopy and arthroscopic subacromial decompression
Arm Type
Experimental
Arm Description
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.
Arm Title
Glenohumeral arthroscopy and skin incision
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Glenohumeral arthroscopy + Arthroscopic Subacromial Decompression
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Glenohumeral arthroscopy + lateral skin incision
Intervention Description
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 Outcome Measure Information:
Title
Shoulder Pain and Disability Index (SPADI)
Description
The primary outcome is SPADI 12 months after surgical intervention.
Time Frame
12 months after surgical intervention.
Secondary Outcome Measure Information:
Title
Shoulder Pain and Disability Index (SPADI)
Description
SPADI is registered as a secondary outcome 3, 6 and 24 months after surgical intervention.
Time Frame
24 months
Title
Oxford Shoulder Score
Description
Oxford Shoulder Score is registered 3, 6, 12 and 24 months after surgical intervention.
Time Frame
24 months
Title
Patient Satisfaction
Description
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).
Time Frame
12 months
Title
Active Shoulder Abduction Range Of Motion (AROM)
Description
Active Shoulder Abduction Range Of Motion is registered at 3 and 12 months after surgical intervention.
Time Frame
12 months
Title
Pain during Active Shoulder Abduction Range Of Motion (NPRS-AROM)
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam Witten, MD
Phone
004528780809
Email
adam.witten.02@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristoffer Barfod, MD
Organizational Affiliation
Sports Orthopedic Research Center - Copenhagen (SORC-C), Hvidovre Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Hvidovre Univeristy Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Witten, MD
Phone
28780809
Email
adam.witten.02@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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