Workers Compensation Board: Rotator Cuff Tear Management

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01498198
• Date of registration: 19/12/2011
• Primary sponsor: University of Manitoba
• Public title: Workers Compensation Board: Rotator Cuff Tear Management
• Scientific title: A Randomized Study of Non-Operative Management Versus Expedited Surgery Among WCB Patients With Small Rotator Cuff Tears: Affect Upon Time to Claim Closure in 2 Prairie Provinces
• Date of first enrolment: January 2012
• Target sample size: 144
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT01498198
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Canada

Contacts

• Name: Jeff Leiter, PhD

• Name: Jeff Leiter, PhD

• Name: Peter B MacDonald, MD FRCSC
• Affiliation: University of Manitoba Faculty of Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patient is over 18 years of age

- Patient has an active WCB Claim

- Patient has a high-grade (>50%) partial-thickness or small (<1cm) full-thickness tear
of the supraspinatus and/or infraspinatus, as confirmed by appropriate diagnostic
imaging (MRI, Arthrogram, Ultrasound)

Exclusion Criteria:

- Patient has a full-thickness tear of the subscapularis and/or teres minor

- Patient has a low-grade (<50%) partial-thickness tear of the
supraspinatus/infraspinatus

- Patient has a moderate to large (>1cm) full-thickness tear of the
supraspinatus/infraspinatus

- Patient has undergone previous RC surgery to the affected shoulder

- Patient has major joint trauma, infection, or avascular necrosis

- Patient has chronic dislocation, inflammation, or degenerative glenohumeral
arthropathy

- Patient has evidence of significant cuff arthropathy (superior glenohumeral
translation and/or acromial erosion, as diagnosed by diagnostic imaging)

- Patient has a psychiatric illness, cognitive impairment, or other health condition
(i.e. visual impairment) which precludes informed consent or renders the patient
unable to complete study questionnaires

- Patient has a major medical illness where life expectancy is less than 2 years

- Patient does not speak/read/understand English

- Patient has no fixed address or means of contact

- Patient unwilling to complete necessary follow-ups



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Rotator Cuff Tear

Intervention(s)

Other: Non Operative Treatment

Procedure: Rotator Cuff Repair Surgery

Primary Outcome(s)

Time to return to final work status [Time Frame: Participations followed for duration of the study, up to 1 year, until they fully return to work]

Secondary Outcome(s)

Demographics [Time Frame: 1 year]

Orebro Questionnaire [Time Frame: 1 year]

Range of Motion [Time Frame: 1 year]

Strength [Time Frame: 1 year]

WORC Questionnaire [Time Frame: 1 year]

Secondary ID(s)

B2011:117

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Alberta