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Anatomic and Clinical Long-term Follow-up of Conservatively Treated Rotator Cuff Tears

Anatomic and Clinical Long-term Follow-up of Conservatively Treated Rotator Cuff Tears

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01829633
Enrollment
49
Registered
2013-04-11
Start date
2012-03-31
Completion date
2017-07-31
Last updated
2018-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Full-thickness Rotator Cuff Tears

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.

Interventions

PROCEDUREPhysiotherapy

Shoulder physiotherapy with exercises

Sponsors

Vestre Viken Hospital Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Shoulder sonographyBaseline to 8-10 years follow-upSonographic 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

MeasureTime frameDescription
Number of relapses during follow-up8 to 10 yearsAt 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-up8 to 10 yearsAt follow-up, patients have to report the number of surgical interventions in their study shoulder since the time of diagnosis.
MRI of the shoulderMRI will be performed at 8 to 10 years follow-upAt 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.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026