Longitudinal Study of Asymptomatic Rotator Cuff Tears

Rotator Cuff Tear Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01085942
• Other study ID #: 288-05082 (REK)
• Secondary ID: 2006049
• Status: Completed
• Phase: N/A
• First received: March 11, 2010
• Last updated: January 19, 2018
• Start date: October 2008
• Est. completion date: August 2011

Study information

• Verified date: January 2018
• Source: Martina Hansen's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear

Locations

Country	Name	City	State
Norway	Martina Hansen's Hospital	Sandvika

Sponsors (1)

Lead Sponsor	Collaborator
Martina Hansen's Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms from a rotator cuff tear	The symptomatic status of initially asymptomatic rotator cuff tears is followed up by reexamination after three and eight years	8 years
Primary	Tear characteristics on MRI and sonography	Tear characteristics from initially asymptomatic rotator cuff tears are followed up by reexamination by MRI and sonography after three and eight years	8 years