Outcome Following Surgery to Repair Rotator Cuff Tears
| Tracking Information | |||||
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| First Received Date ICMJE | November 30, 2005 | ||||
| Last Updated Date | October 24, 2011 | ||||
| Start Date ICMJE | November 2004 | ||||
| Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Rate of re-tear at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Rate of re-tear at 1 year | ||||
| Change History | Complete list of historical versions of study NCT00260949 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Functional outcome Anatomical integrity [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Functional outcome Anatomical integrity | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Outcome Following Surgery to Repair Rotator Cuff Tears | ||||
| Official Title ICMJE | Functional and Anatomical Results Following Arthroscopic Cuff Repair | ||||
| Brief Summary | There are two ways in which surgeons repair rotator cuff tears. An open method involves making an incision (cut) 5-6 inches in length in the skin and repairing the tear with the skin open, while the arthroscopic method involves making small holes in the skin and using a guiding camera and special equipment to repair the tear. This clinical study is being conducted to study the rate of re-tear (one year following surgery) of rotator cuffs that have been repaired using the arthroscopic technique. |
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| Detailed Description | While many studies have researched re-tear rate for rotator cuff tears following open repair, to date there have been no studies evaluating re-tear rate following arthroscopic surgery. Arthroscopic rotator cuff repair is less invasive and exposes the patient to fewer risks than open surgery. Once this pilot study is completed the next step will be to compare the rate of re-tear, as assessed via Magnetic Resonance Imaging (MRI) between the two techniques. If the rate of re-tear is lower following arthroscopic surgery this will provide validation for use of the arthroscopic technique. If, however, the rate of re-tear is higher using the arthroscopic technique, then use of this technique is not justified. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Rotator Cuff Tear | ||||
| Intervention ICMJE | Procedure: Arthroscopic repair of rotator cuff tear
Patients will undergo arthroscopic shoulder surgery in the standard fashion |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Completion Date | September 2011 | ||||
| Primary Completion Date | August 2011 (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 Number ICMJE | NCT00260949 | ||||
| Other Study ID Numbers ICMJE | OHREB 2003534-01H | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Ottawa Hospital Research Institute | ||||
| Study Sponsor ICMJE | Ottawa Hospital Research Institute | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Ottawa Hospital Research Institute | ||||
| Verification Date | October 2011 | ||||
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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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