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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 January 2013 |
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Main ID: |
NCT01333527 |
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Date of registration:
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08/04/2011 |
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Primary sponsor: |
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Public title:
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Early Mobilization Following Arthroscopic Rotator Cuff Repair
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Scientific title:
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Early Mobilization Following Arthroscopic Rotator Cuff Repair: a Randomized Controlled Trial |
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Date of first enrolment:
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April 2011 |
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Target sample size:
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200 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01333527 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Canada
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Contacts
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Name:
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Megan Sergenson |
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Address:
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Telephone:
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1-780-492-4752 |
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Email:
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Affiliation:
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Name:
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Anelise Silveira |
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Address:
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Telephone:
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780-407-6992 |
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Email:
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anelise.silveira@albertahealthservices.ca |
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Affiliation:
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Name:
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David Sheps, MD,MSc,FRCSC |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Alberta |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patient is over 18 years of age
2. Patient has attempted non-operative treatment (i.e. physical therapy consisting of
progressive ROM, strengthening, and postural exercises)
3. Patient has a full-thickness tear of the supraspinatus and/or infraspinatus, as
confirmed by appropriate diagnostic imaging (MRI, Arthrogram, Ultrasound)
Exclusion Criteria:
1. Patient has a full-thickness tear of the subscapularis and/or teres minor
2. Patient has undergone previous RC surgery to the affected shoulder
3. Patient has major joint trauma, infection, or avascular necrosis
4. Patient has chronic dislocation, inflammation, or degenerative glenohumeral
arthropathy
5. Patient has evidence of significant cuff arthropathy (superior glenohumeral
translation and/or acromial erosion, as diagnosed by diagnostic imaging)
6. 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
7. Patient has a major medical illness where life expectancy is less than 2 years
8. Patient does not speak/read/understand English
9. Patient has no fixed address or means of contact
10. Surgeon or patient has decided to cancel surgery
11. Surgeon concludes that an arthroscopic repair is not appropriate at time of surgery
(based on RC tear characteristics or concomitant shoulder pathology)
12. Patient unwilling to complete necessary follow-ups
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Rotator Cuff Tear
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Intervention(s)
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Procedure: No Sling
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Procedure: Sling
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Primary Outcome(s)
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WORC Questionnaire
[Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months]
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Secondary Outcome(s)
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Adverse Events
[Time Frame: 2 weeks, 6 weeks, 3 months, 6months]
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ASES
[Time Frame: baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months]
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Range of Motion (ROM)
[Time Frame: baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months]
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SF-36
[Time Frame: baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months]
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Strength
[Time Frame: Baseline, 6 months, 12 months, 24 months]
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Secondary ID(s)
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RES0005824
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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