Comparing Two Surgical Methods of Fixation of Subscapularis During Shoulder Arthroplasty
This study has been completed.
Sponsor:
Ottawa Hospital Research Institute
Information provided by (Responsible Party):
Dr. P. Lapner, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00508105
First received: July 25, 2007
Last updated: April 11, 2012
Last verified: April 2012
| Tracking Information | |||||
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| First Received Date ICMJE | July 25, 2007 | ||||
| Last Updated Date | April 11, 2012 | ||||
| Start Date ICMJE | November 2006 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
to assess quality of life post-operatively of each surgical group [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00508105 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparing Two Surgical Methods of Fixation of Subscapularis During Shoulder Arthroplasty | ||||
| Official Title ICMJE | Comparison of Two Methods of Fixation of Subscapularis During Shoulder Arthroplasty | ||||
| Brief Summary | This pilot study is being conducted to compare 2 methods of access to the shoulder for arthroplasty in patients with Osteoarthritis as we do not know has a better outcome. |
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| Detailed Description | The study investigates the difference in disease specific quality of life between patients who undergo a subscapularis tenotomy versus morselized osteotomy of the lesser tuberosity, as measured by the Western Ontario Osteoarthritis of the Shoulder (WOOS) at one year post-operatively in patients who undergo shoulder arthroplasty ? |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| 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 | ||||
| Enrollment ICMJE | 87 | ||||
| Completion Date | December 2011 | ||||
| Primary Completion Date | December 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 | NCT00508105 | ||||
| Other Study ID Numbers ICMJE | OHREB2006489-0H | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. P. Lapner, 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 | April 2012 | ||||
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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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