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Tracking Information | |||||
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First Received Date † | March 6, 2007 | ||||
Last Updated Date | March 6, 2007 | ||||
Start Date † | March 2007 | ||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation | ||||
Official Title † | Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation | ||||
Brief Summary | The purpose of this study is to compare patients who underwent decompression/discectomy with pedicle screw fusion to patients who received decompression/discectomy without fusion. |
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Detailed Description | Lumbar disc herniations are quite common and typically improve after surgical correction. However, some patients develop recurrent herniations at the same level. Controversy exists as to why reherniated discs occur. Moreover, existing research does not settle the issue of whether a second decompression/discectomy or a repeat decompression/discectomy with pedicle screw fusion is the more successful treatment. This study is designed to compare differences in patient-reported pain, physical function, and satisfaction between the two types of surgery patients. |
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Study Phase | Phase IV | ||||
Study Type † | Observational | ||||
Study Design † | Longitudinal, Defined Population, Prospective Study | ||||
Condition † |
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Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* 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 † | Recruiting | ||||
Enrollment † | 50 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 75 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
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Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00444405 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | St. John's Health System | ||||
Collaborators †† | Zimmer, Inc. | ||||
Investigators † |
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Information Provided By | St. John's Health System | ||||
Verification Date | March 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |