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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 7, 2005 | ||||||||
| Last Updated Date | January 14, 2008 | ||||||||
| Start Date ICMJE | March 1999 | ||||||||
| Primary Completion Date | October 2005 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Rotator Cuff Quality of Life Questionnaire (RC-QOL) [ Time Frame: Baseline, 3, 6, 12, 24 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Rotator Cuff Quality of Life Questionnaire (RC-QOL) | ||||||||
| Change History | Complete list of historical versions of study NCT00251147 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||||||
| Brief Title ICMJE | A Randomized Clinical Trial Comparing Open to Mini-Open Rotator Cuff Repair for Full-Thickness Rotator Cuff Tears. | ||||||||
| Official Title ICMJE | Prospective Randomized Study Comparing Open Acromioplasty and Rotator Cuff Repair Versus Arthroscopic Acromioplasty and Mini-Open Rotator Cuff Repair. | ||||||||
| Brief Summary | This study compares standard open rotator cuff repair versus arthroscopic mini-open rotator cuff repair by measuring the disease-specific quality of life at 2 years in patients with full thickness rotator cuff tears. Hypothesis: There is no difference in disease-specific quality of life outcome at two years between open versus arthroscopic mini-open repair for patients with full-thickness rotator cuff tears. |
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| Detailed Description | Rotator cuff injury affects a diverse group of patients and leads to significant disability with respect to lost time from work and the inability to play sports, thereby affecting the individual's quality of life. The standard treatment for full-thickness rotator cuff repair is with an open acromioplasty procedure. An alternative procedure for a full-thickness rotator cuff tear is with a combined procedure of arthroscopic acromioplasty and mini-open repair, which has the potential advantages of a preserved deltoid origin, lower perioperative morbidity, shorter hospital stays and less soft tissue dissection. The progression towards arthroscopic repair requires a comparison to the standard, open procedure for full-thickness rotator cuff tears, using validated outcomes in a randomized fashion. This study is designed as a multi-centre randomized controlled trial with a priori sample size calculation of 28 patients per group. Patients presenting with unremitting pain, failed conservative treatment of at least 3 months, weakness of the rotator cuff and positive imaging indicating a full-thickness rotator cuff tear are eligible for the study. Previous surgery on the affected shoulder and massive rotator cuff tears are excluded. Patients are randomized using computer-generated block randomization, stratified by surgeon, to either open or mini-open rotator cuff repair. Disease-specific quality of life is assessed using the validated Rotator Cuff Quality of Life Questionnaire, a self-administered, 34-item questionnaire designed specifically to assess patients before and after surgery. It utilizes a visual analog scale scored out of 100, with a higher score reflecting a better quality of life. |
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE | Rotator Cuff Tear | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 73 | ||||||||
| Completion Date | October 2005 | ||||||||
| Primary Completion Date | October 2005 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00251147 | ||||||||
| Responsible Party | Denise Chan, Orthopaedic Research Coordinator, University of Calgary | ||||||||
| Study ID Numbers ICMJE | 10368 | ||||||||
| Study Sponsor ICMJE | University of Calgary | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of Calgary | ||||||||
| Verification Date | January 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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