NCT01085942

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

2.7 years

First QC Date

March 11, 2010

Last Update Submit

January 19, 2018

Conditions

Keywords

rotator cuff tearasymptomaticnatural coursetear characteristicsAsymptomatic rotator cuff tearsNatural course of rotator cuff tears

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Asymptomatic rotator cuff tear

Subjects identified with an asymptomatic rotator cuff tear

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects identified with an asymptomatic rotator cuff tear

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Martina Hansen's Hospital

Sandvika, 1306, Norway

Location

Related 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. No abstract available.

    PMID: 23864184BACKGROUND
  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Stefan Moosmayer, MD

    Vestre Viken Hospital Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 11, 2010

First Posted

March 12, 2010

Study Start

October 1, 2008

Primary Completion

June 1, 2011

Study Completion

August 1, 2011

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations