Clinical trial NCT01085942: Longitudinal Study of Asymptomatic Rotator Cuff Tears
Official title: Longitudinal Study of Asymptomatic Rotator Cuff Tears. A Eight Year Follow-up of Symptomatic Status and Tear Characteristics Like Tear Size, Muscle Atrophy and Fatty Degeneration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tear
Keywords: rotator cuff tear
asymptomatic
natural course
tear characteristics
Asymptomatic rotator cuff tears
Natural course of rotator cuff tears
Lead sponsor: Martina Hansen's Hospital
Sponsor class: OTHER
First posted: 2010-03-12
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects identified with an asymptomatic rotator cuff tear

Brief summary: The purpose of this study is to analyze the natural course of asymptomatic rotator cuff tears.

Detailed description: Fifty subjects with an asymptomatic rotator cuff tear were identified in an earlier study. Clinical, sonographic and MRI reexamination of these subjects is performed after an interval of three years. Findings of interest include: (1) the symptomatic status of the subjects (still asymptomatic or symptomatic); (2)tear size on sonography and MRI (unchanged or increased); (3)degree of muscle atrophy on MRI (unchanged or deteriorated); (4)degree of fatty muscle degeneration on MRI (unchanged or deteriorated). We want to analyze whether a change in these tear characteristics is associated with a change of the symptomatic status of these subjects.

Eligibility criteria: Inclusion Criteria:

* Subjects with an asymptomatic rotator cuff tear at least in one shoulder, tear demonstrated both on MRI and sonography, ASES score exceeding 90 points

Exclusion Criteria:

* Earlier periods with shoulder pain and dysfunction, earlier treatment for shoulder problems

Primary outcomes:
measure: Symptoms from a rotator cuff tear
timeFrame: 8 years
measure: Tear characteristics on MRI and sonography
timeFrame: 8 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sandvika
country: Norway
facility: Martina Hansen's Hospital
Study officials:
affiliation: Martina Hansen's Hospital
name: Stefan Moosmayer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Keener JD. Surveillance of conservatively treated rotator cuff tears is warranted. Commentary on an article by Stefan Moosmayer, MD, PhD, et al.: "The natural history of asymptomatic rotator cuff tears. a three-year follow-up of fifty cases". J Bone Joint Surg Am. 2013 Jul 17;95(14):e101 1-2. doi: 10.2106/JBJS.M.00526. No abstract available.
citation: Moosmayer S, Smith HJ, Tariq R, Larmo A. Prevalence and characteristics of asymptomatic tears of the rotator cuff: an ultrasonographic and clinical study. J Bone Joint Surg Br. 2009 Feb;91(2):196-200. doi: 10.1302/0301-620X.91B2.21069.
citation: Moosmayer S, Tariq R, Stiris MG, Smith HJ. MRI of symptomatic and asymptomatic full-thickness rotator cuff tears. A comparison of findings in 100 subjects. Acta Orthop. 2010 Jun;81(3):361-6. doi: 10.3109/17453674.2010.483993.
citation: Moosmayer S, Tariq R, Stiris M, Smith HJ. The natural history of asymptomatic rotator cuff tears: a three-year follow-up of fifty cases. J Bone Joint Surg Am. 2013 Jul 17;95(14):1249-55. doi: 10.2106/JBJS.L.00185.