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Workers Compensation Board: Rotator Cuff Tear Management

NCT01498198 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2011-12-23

No results posted yet for this study

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. 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. Are there subject, tear or work-related characteristics that affect which patient management approach will be most effective and efficient?

Conditions

  • Rotator Cuff Tear

Interventions

PROCEDURE

Rotator Cuff Repair Surgery

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

OTHER

Non Operative Treatment

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.

Sponsors & Collaborators

  • University of Alberta

    collaborator OTHER

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Peter B MacDonald, MD FRCSC · University of Manitoba Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01498198 on ClinicalTrials.gov