Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder Pain and Disability Index (SPADI) | The primary outcome is SPADI 12 months after surgical intervention. | 12 months after surgical intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder Pain and Disability Index (SPADI) | SPADI is registered as a secondary outcome 3, 6 and 24 months after surgical intervention. | 24 months |
| Oxford Shoulder Score | Oxford Shoulder Score is registered 3, 6, 12 and 24 months after surgical intervention. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adam Witten, MD | Contact | 004528780809 | adam.witten.02@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Kristoffer Barfod, MD | Sports Orthopedic Research Center - Copenhagen (SORC-C), Hvidovre Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hvidovre Univeristy Hospital | Recruiting | Hvidovre | Denmark | 2650 | Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 24 months |
| Patient Satisfaction | Patient satisfaction will be assessed using three questions:
| 12 months |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D019534 | Shoulder Impingement Syndrome |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070599 | Shoulder Injuries |
| D014947 | Wounds and Injuries |
Not provided
Not provided