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

NCT01829633 | Completed DMC

• 2 other identifiers: 29144/3/LT2011/1931
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of relapses during follow-up

  8 to 10 years

• Number of patients who needed surgical treatment of their shoulder during follow-up

  8 to 10 years

• MRI of the shoulder

  MRI will be performed at 8 to 10 years follow-up

Study Arms (1)

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

Interventions

Physiotherapy PROCEDURE

Shoulder physiotherapy with exercises

Rotator cuff tears

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vestre Viken Hospital Trust: lead

Study Sites (1)

Martina Hansen's Hospital

Sandvika, 1306, Norway

Location

Related Publications (1)

• 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.

  PMID: 28089257 RESULT

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Stefan Moosmayer, MD, PhD

  Vestre Viken Hospital Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 9, 2013
• First Posted: April 11, 2013
• Study Start: March 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: July 1, 2017
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

NO (1)