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

Completed

• Conditions: Full-thickness Rotator Cuff Tears
• Interventions: Procedure: Physiotherapy

• Registration Number: NCT01829633
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2013-04-09
• Study First Submitted QC: 2013-04-09
• Study First Posted: 2013-04-11
• Primary Completion: 2016-02
• Study Completion: 2017-07
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rotator cuff tears	Physiotherapy	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.

Primary Outcome Measures

Name	Time	Method
Shoulder sonography	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

Name	Time	Method
Number of patients who needed surgical treatment of their shoulder during follow-up	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	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.
Number of relapses during follow-up	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

Trial Locations

Locations (1)

Martina Hansen's Hospital; 🇳🇴 Sandvika, Norway