Clinical trial NCT01829633: Anatomic and Clinical Long-term Follow-up of Conservatively Treated Rotator Cuff Tears
Official title: Anatomic and Clinical Long-term Follow-up of Conservatively Treated Rotator Cuff Tears
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Full-thickness Rotator Cuff Tears
Lead sponsor: Martina Hansen's Hospital
Sponsor class: OTHER
First posted: 2013-04-11
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: Shoulder sonography
timeFrame: Baseline to 8-10 years follow-up
Secondary outcomes:
measure: Number of relapses during follow-up
timeFrame: 8 to 10 years
measure: Number of patients who needed surgical treatment of their shoulder during follow-up
timeFrame: 8 to 10 years
measure: MRI of the shoulder
timeFrame: MRI will be performed at 8 to 10 years follow-up
Other outcomes:
Locations:
city: Sandvika
country: Norway
facility: Martina Hansen's Hospital
Study officials:
affiliation: Martina Hansen's Hospital
name: Stefan Moosmayer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moosmayer S, Gartner 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. Epub 2017 Jan 12.