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

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.

Study Overview

• Status: Completed
• Conditions: Full-thickness Rotator Cuff Tears
• Intervention / Treatment: Procedure: Physiotherapy

• Study Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

Study Locations

• Norway
  • Sandvika, Norway, 1306
    • Martina Hansen's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder sonography	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	Baseline to 8-10 years follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of relapses during follow-up	At follow-up patients have to report how many new periods with shoulder pain they have experienced since the time of diagnosis	8 to 10 years
Number of patients who needed surgical treatment of their shoulder during follow-up	At follow-up, patients have to report the number of surgical interventions in their study shoulder since the time of diagnosis.	8 to 10 years
MRI of the shoulder	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.	MRI will be performed at 8 to 10 years follow-up

Collaborators and Investigators

• Sponsor: Martina Hansen's Hospital
• Investigators: Principal Investigator: Stefan Moosmayer, MD, PhD, Martina Hansen's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: April 9, 2013
• First Submitted That Met QC Criteria: April 9, 2013
• First Posted (Estimate): April 11, 2013

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 19, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 29144/3/LT; 2011/1931 (Other Identifier: Regional Committees for Medical and Health Research Ethics)