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Completed

NCT Number: NCT01829633

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.

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Key information

Conditions

Full-thickness Rotator Cuff Tears

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Martina Hansen's Hospital

Sandvika, 1306, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

physiotherapy

Procedure

Shoulder physiotherapy with exercises

Primary outcomes

  1. Shoulder sonography

    Time frame: 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 outcomes

  1. Number of relapses during follow-up

    Time frame: 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

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

    Time frame: 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.

  3. MRI of the shoulder

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vestre Viken Hospital Trust

Other

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Apr 11, 2013
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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