Anatomic and Clinical Long-term Follow-up of Conservatively Treated Rotator Cuff Tears
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|ClinicalTrials.gov Identifier: NCT01829633|
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : January 23, 2018
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.
|Condition or disease||Intervention/treatment|
|Full-thickness Rotator Cuff Tears||Procedure: Physiotherapy|
|Study Type :||Observational|
|Actual Enrollment :||49 participants|
|Official Title:||Anatomic and Clinical Long-term Follow-up of Conservatively Treated Rotator Cuff Tears|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||July 2017|
Rotator cuff tears
Patients who were diagnosed with a symptomatic full-thickness tear of the rotator cuff. Tear examination by sonography and MRI showed a repairable tear. All patients were initially treated conservatively by physiotherapy.
Shoulder physiotherapy with exercises
- Shoulder sonography [ Time Frame: Baseline to 8-10 years follow-up ]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
- Number of relapses during follow-up [ Time Frame: 8 to 10 years ]At follow-up patients have to report how many new periods with shoulder pain they have experienced since the time of diagnosis
- Number of patients who needed surgical treatment of their shoulder during follow-up [ Time Frame: 8 to 10 years ]At follow-up, patients have to report the number of surgical interventions in their study shoulder since the time of diagnosis.
- MRI of the shoulder [ Time Frame: MRI will be performed at 8 to 10 years follow-up ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829633
|Martina Hansen's Hospital|
|Sandvika, Norway, 1306|
|Principal Investigator:||Stefan Moosmayer, MD, PhD||Martina Hansen's Hospital|