Workers Compensation Board: Rotator Cuff Tear Management

NCT01498198 | Unknown

• 1 other identifier: B2011:117
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this proposed randomized study is to determine if surgery at the time of diagnosis or rehabilitation +/- surgery (i.e. surgery only when rehabilitation fails) results in shorter times to claim closure. The study will examine how often non-operative management is successful in resolving symptoms and allowing subjects to return to work without surgery. The investigators will also examine if there are subject, tear or work-related characteristics that affect the outcome of rehabilitation or expedited surgery and predict whether patients should be referred to operative or non-operative management at time of assessment. At study completion, the investigators expect to be able to definitively state the best management for subjects with these less serious RC tears. The specific research questions to be addressed are as follows:

1. 1.In WCB subjects with high grade partial thickness (\>50%) or small full thickness (≤ 1 cm.) rotator cuff tears, how does non-operative management (i.e. rehabilitation) or expedited surgery affect time to claim closure?
2. 2.Are there subject, tear or work-related characteristics that affect which patient management approach will be most effective and efficient?

Conditions

Rotator Cuff Tear

Keywords

Rotator Cuff; WCB

Outcome Measures

Primary Outcomes (1)

• Time to return to final work status

  To answer our primary research question, time to return to work (in days) will be calculated. This will be defined as the interval from the date of orthopedic consultation/screening to final return to work status. We will also determine the time to any return to work status.

  Participations followed for duration of the study, up to 1 year, until they fully return to work

Secondary Outcomes (5)

• Demographics

  1 year

• Range of Motion

  1 year

• WORC Questionnaire

  1 year

• Orebro Questionnaire

  1 year

• Strength

  1 year

Study Arms (2)

Expedited Surgery

EXPERIMENTAL

Participants will have surgery within 3 months

Procedure: Rotator Cuff Repair Surgery

Non Operative Management

EXPERIMENTAL

Participants will undergo non operative care for as long as they are improving, and will return to the surgeon when no progression is reached.

Other: Non Operative Treatment

Interventions

Rotator Cuff Repair Surgery PROCEDURE

Participants will have surgery within 3 months. They will be followed up at 6 weeks, 12 weeks, 6 months and 12 months pos operatively.

Expedited Surgery

Non Operative Treatment OTHER

Participants will undergo a 6 week assessment, and if they are improving they will continue undergoing non operative care up until 12 months. If at any assessment point (6 weeks, 12 weeks, 6 months, 12 months) they are deemed to not be making any more progression, they will be referred back to the surgeon.

Non Operative Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead
• University of Alberta: collaborator

Study Sites (1)

Pan Am Clinic

Winnipeg, Manitoba, R3M 3E4, Canada

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Peter B MacDonald, MD FRCSC

  University of Manitoba Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeff Leiter, PhD

CONTACT

204-927-2665; jleiter@panamclinic.com

Alexandra J Gilhen, BSc

CONTACT

204-925-1558; agilhen@panamclinic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pan Am Clinic Medical Director and University of Manitoba Faculty of Medicine Professor

Study Record Dates

• First Submitted: December 19, 2011
• First Posted: December 23, 2011
• Study Start: January 1, 2012
• Primary Completion: January 1, 2014
• Last Updated: December 23, 2011

Record last verified: 2011-12

Locations

CA (1)