Symptomatic, Biomechanical and Radiographic Outcomes in Knee Osteoarthritis Following Gastric Bypass Surgery
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | October 5, 2006 | ||||
| Start Date ICMJE | February 2003 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00194051 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 | Symptomatic, Biomechanical and Radiographic Outcomes in Knee Osteoarthritis Following Gastric Bypass Surgery | ||||
| Official Title ICMJE | Symptomatic, Biomechanical and Radiographic Outcomes in Knee Osteoarthritis Following Gastric Bypass Surgery | ||||
| Brief Summary | Weight is a risk factor for knee osteoarthritis Knee osteoarthritis is associated with abnormal gait biomechanics Gait biomechanics are evaluated in gastric bypass patients before and after losing 100 pounds. |
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| Detailed Description | Weight is a major risk factor for development of knee osteoarthritis, but not hip or ankle arthritis. One possible mechanism for this is the generation of abnormal gait biomechanics secondary to obesity that are conducive to the development of knee osteoarthritis. We evaluate gait biomechanics, knee symptoms and knee radiographs in 35 obese patients before and after gastric bypass surgery to determine the effect of significant weight loss on gait biomechanics, knee symptoms and knee radiographs. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Defined Population Observational Model: Natural History Time Perspective: Longitudinal Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE |
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| Intervention ICMJE | Procedure: gastric bypass surgery | ||||
| Study Group/Cohort (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 | Active, not recruiting | ||||
| Enrollment ICMJE | 35 | ||||
| Completion Date | May 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Undergoing gastric bypass surgery At least 35 years old - Exclusion Criteria: Inability to walk unassisted Pain affecting gait in any lower extremity joint - |
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| Gender | Both | ||||
| Ages | 35 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00194051 | ||||
| Other Study ID Numbers ICMJE | 02-03-10 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | University Hospitals of Cleveland | ||||
| Collaborators ICMJE | Elizabeth Severance Prentiss Foundation | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospitals of Cleveland | ||||
| Verification Date | September 2005 | ||||
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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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