NCT04644042 The Effect of Arthroscopic Subacromial Decompression in Patients Who Are Non-responders to Non-operative Treatment.
| NCT ID | NCT04644042 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hvidovre University Hospital |
| Condition | Subacromial Impingement Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2021-09-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2021-09-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Kristoffer Barfod, MD
STUDY DIRECTOR
Sports Orthopedic Research Center - Copenhagen (SORC-C), Hvidovre Hospital
Frequently Asked Questions
Who can join the NCT04644042 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Subacromial Impingement Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04644042 currently recruiting?
Yes, NCT04644042 is actively recruiting participants. Contact the research team at adam.witten.02@regionh.dk for enrollment information.
Where is the NCT04644042 trial being conducted?
This trial is being conducted at Hvidovre, Denmark.
Who is sponsoring the NCT04644042 clinical trial?
NCT04644042 is sponsored by Hvidovre University Hospital. The principal investigator is Kristoffer Barfod, MD at Sports Orthopedic Research Center - Copenhagen (SORC-C), Hvidovre Hospital. The trial plans to enroll 160 participants.