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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
Sponsor:
Information provided by (Responsible Party):
Stefan Moosmayer, Martina Hansen's Hospital

Brief Summary:

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

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Study Type : Observational
Actual Enrollment : 49 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Group/Cohort Intervention/treatment
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.
Procedure: Physiotherapy
Shoulder physiotherapy with exercises




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with a symptomatic full-thickness rotator cuff tear in the period 2002 to 2005. All tears were deemed to be repairable at the time of the diagnosis
Criteria

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

Information from the National Library of Medicine

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


Locations
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Norway
Martina Hansen's Hospital
Sandvika, Norway, 1306
Sponsors and Collaborators
Martina Hansen's Hospital
Investigators
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Principal Investigator: Stefan Moosmayer, MD, PhD Martina Hansen's Hospital
Publications of Results:
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Responsible Party: Stefan Moosmayer, MD, PhD, Martina Hansen's Hospital
ClinicalTrials.gov Identifier: NCT01829633    
Other Study ID Numbers: 29144/3/LT
2011/1931 ( Other Identifier: Regional Committees for Medical and Health Research Ethics )
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries