Full-thickness Rotator Cuff Tears Clinical Trial
Official title:
Anatomic and Clinical Long-term Follow-up of Conservatively Treated Rotator Cuff Tears
| Verified date | January 2018 |
| Source | Martina Hansen's Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Study population: Patients who have been treated with physiotherapy for a potentially
repairable rotator cuff tear in the period from 2002 to 2005.
Study Method: At the time of diagnosis (2002 to 2005) all study patients were examined
clinically, sonographically and by MRI. Some patients also completed a shoulder score. All
study patients will now be reexamined, 8 to 10 years after they were diagnosed. Reexamination
includes history taking, clinical examination, completion of three shoulder scores (two
shoulder specific scores, one general health score), Sonography and MRI. Findings of interest
are
- the number of relapses during follow-up,
- the need for surgical treatment during follow-up,
- the deterioration of tear anatomy (tear size, muscle atrophy, fatty degeneration) during
follow-up
- the actual clinical shoulder condition (as given by shoulder scores) at reexamination.
Study purpose: We want to assess the anatomic and clinical long-term results of physiotherapy
for potentially repairable rotator cuff tears. We want to find out if tear anatomy of
unrepaired rotator cuff tears deteriorates over time and if such a deterioration is
associated with a development of more serious degrees of symptoms.
| Status | Completed |
| Enrollment | 49 |
| Est. completion date | July 2017 |
| Est. primary completion date | February 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Full-thickness rotator cuff tear diagnosed between 2002 and 2005 by both sonography and MRI. At the time of diagnosis (2002 to 2005): - Typical clinical symptoms for a rotator cuff tear including pain laterally on upper humerus, painful arc, positive impingement test (Neer or Hawkins) - Potentially repairable tear (tear size up to 3 cm, muscle atrophy not exceeding grade 2 according to Thomazeau, fatty degeneration not exceeding grade 1 according to Goutallier). - Treated by physiotherapy for at least 3 months Exclusion Criteria: At the time of diagnosis (2002 to 2005): - Full-thickness tears of the subscapularis tendon or of the entire supraspinatus and infraspinatus tendons - Other symptomatic shoulder pathology including long head of the biceps tendon pathology, acromioclavicular joint pathology, shoulder instability, inflammatory diseases, glenohumeral arthritis - Earlier treated with rotator cuff repair in the study shoulder |
| Country | Name | City | State |
|---|---|---|---|
| Norway | Martina Hansen's Hospital | Sandvika |
| Lead Sponsor | Collaborator |
|---|---|
| Martina Hansen's Hospital |
Norway,
Moosmayer S, Gärtner AV, Tariq R. The natural course of nonoperatively treated rotator cuff tears: an 8.8-year follow-up of tear anatomy and clinical outcome in 49 patients. J Shoulder Elbow Surg. 2017 Apr;26(4):627-634. doi: 10.1016/j.jse.2016.10.002. Ep — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Shoulder sonography | Sonographic shoulder examination was performed for all study patients before treatment was given. All patients will be reexamined by sonography after 8 to 10 years. The finding of interest is the change of tear size as determined by sonography | Baseline to 8-10 years follow-up | |
| Secondary | Number of relapses during follow-up | At follow-up patients have to report how many new periods with shoulder pain they have experienced since the time of diagnosis | 8 to 10 years | |
| Secondary | Number of patients who needed surgical treatment of their shoulder during follow-up | At follow-up, patients have to report the number of surgical interventions in their study shoulder since the time of diagnosis. | 8 to 10 years | |
| Secondary | MRI of the shoulder | At the time of diagnosis, no patient had serious muscle atrophy or fatty degeneration as determined by MRI. The finding of interest at 8 to 10 years follow-up is the number of patients who have progressed to serious muscle atrophy or fatty degeneration during follow-up. | MRI will be performed at 8 to 10 years follow-up |