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

NCT ID: NCT01829633

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 49 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2017-07-31

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.

Conditions

Full-thickness Rotator Cuff Tears

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Physiotherapy

Intervention Type: PROCEDURE

Shoulder physiotherapy with exercises

Interventions

Physiotherapy

Shoulder physiotherapy with exercises

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Martina Hansen's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Stefan Moosmayer

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefan Moosmayer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Martina Hansen's Hospital

Locations

Martina Hansen's Hospital

Sandvika, , Norway

Countries

Norway

References

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.

Reference Type: RESULT

PMID: 28089257 (View on PubMed)

Other Identifiers

2011/1931

Identifier Type: OTHER

Identifier Source: secondary_id

29144/3/LT

Identifier Type: -

Identifier Source: org_study_id