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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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17 June 2013 |
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Main ID: |
NCT01383239 |
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Date of registration:
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24/06/2011 |
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Primary sponsor: |
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Public title:
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Impact of Postoperative Management on Outcomes and Healing of Rotator Cuff Repairs
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Scientific title:
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Impact of Postoperative Management on Outcomes and Healing of Rotator Cuff Repairs |
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Date of first enrolment:
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June 2011 |
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Target sample size:
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214 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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http://clinicaltrials.gov/show/NCT01383239 |
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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)
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Countries of recruitment
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United States
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Contacts
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Name:
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John E Kuhn, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Vanderbilt University |
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Name:
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Warren R Dunn, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Vanderbilt University |
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Name:
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Charles Cox, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Vanderbilt Unversity Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients for inclusion based on MRI documented full thickness supraspoinatus tear
with acute tears, or chronic tears that fail non-operative therapy.
- Tears that involve the supraspinatus and are minimally displaced (Grade I) or
displaced to the humeral head (Grade II) will be included
Exclusion Criteria:
1. Age < 18 years
2. Evidence of major joint trauma, infection, avascular necrosis, chronic dislocation,
inflammatory or degenerative glenohumeral arthropathy, frozen shoulder, or previous
surgery of the affected shoulder,
3. Evidence of significant cuff arthropathy with superior humeral translation and
acromial erosion diagnosed by x-ray or other investigations,
4. Major medical illness (life expectancy < 2 years or unacceptably high operative
risk),
5. Unable to speak or read English,
6. Psychiatric illness that precludes informed consent,
7. Unwilling to be followed for 2 years,
8. Large, massive, or irreparable cuff tears extending into the subscapularis or teres
minor,
9. Inelastic and immobile tendon which cannot be advanced to articular margin,
10. Co-existing labral pathologies requiring repair (SLAP II-IV), Bankart lesions
requiring repair, partial tears of biceps (more than 60% of thickness) requiring
surgical treatment,
11. Acromioclavicular pathology requiring a distal clavicle excision.
Age minimum:
18 Years
Age maximum:
N/A
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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Other: Delayed Physical Therapy
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Other: Immediate Postoperative Therapy
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Primary Outcome(s)
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Score of the Western Ontario Rotator Cuff Index(WORC)12 months after surgery.
[Time Frame: 12 months]
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Secondary Outcome(s)
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Evaluate postoperatively MR imaging 12 months after surgery.
[Time Frame: 12 months]
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Secondary ID(s)
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#110556
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OREF/ASES/Rockwood Grant
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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