XLIF® vs. MAS®TLIF for the Treatment of Symptomatic Lumbar Degenerative Spondylolisthesis With or Without Central Stenosis.
| Tracking Information | |
|---|---|
| First Received Date ICMJE | December 1, 2009 |
| Last Updated Date | May 15, 2013 |
| Start Date ICMJE | November 2009 |
| Estimated Primary Completion Date | February 2014 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
The average improvement in clinical function (ODI) at 24 months compared with baseline, for each procedure. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT01024699 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
The average improvement in pain (VAS) at 24 months compared with baseline, for each procedure. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ] |
| Original Secondary Outcome Measures ICMJE | Same as current |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | XLIF® vs. MAS®TLIF for the Treatment of Symptomatic Lumbar Degenerative Spondylolisthesis With or Without Central Stenosis. |
| Official Title ICMJE | A Prospective Multi-Center Randomized Evaluation of the Clinical and Radiographic Outcomes of XLIF® Compared With MAS® TLIF for the Treatment of Symptomatic Lumbar Degenerative Spondylolisthesis With or Without Central Stenosis |
| Brief Summary | The purpose of this study is to determine differences in the XLIF and TLIF procedures with respect to perioperative variables in adult patients with low-grade symptomatic spondylolisthesis. |
| Detailed Description | The study is a prospective multi-center randomized evaluation of clinical and radiographic outcomes of two commonly used lumbar interbody fusion procedures (XLIF and TLIF) in adult patients with low-grade symptomatic spondylolisthesis. The study seeks to identify differences between the procedures with respect to perioperative variables. |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Probability Sample |
| Study Population | Study population will consist of patients from participating site locations. |
| Condition ICMJE | Spondylolisthesis |
| Intervention ICMJE | Not Provided |
| Study Group/Cohort (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 | Active, not recruiting |
| Estimated Enrollment ICMJE | 110 |
| Estimated Completion Date | February 2014 |
| Estimated Primary Completion Date | February 2014 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria: - Male and female patients who are at least 18 years of age; - Patients who present with symptomatic Grade I or II degenerative spondylolisthesis at 1 or 2 contiguous lumbar levels between L1 and L5 and are surgical candidates for interbody lumbar fusion surgery; symptoms should include radiculopathy and/or neurogenic claudication with or without back pain; - Patients who have been unresponsive to at least 6 months of conservative treatments or exhibit progressive neurological symptoms in the face of conservative treatment; - Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the study. Exclusion Criteria: - Patients with lumbar pathologies requiring treatment at more than 2 levels; - Patients who have had previous lumbar fusion surgery; - Patients with lytic spondylolisthesis or a defect of the pars interarticularis; - Patients with radiographic confirmation of Grade IV facet joint disease or degeneration; - Patients with non-contained or extruded herniated nucleus pulposus |
| 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 | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT01024699 |
| Other Study ID Numbers ICMJE | NUVA.X0901 |
| Has Data Monitoring Committee | No |
| Responsible Party | NuVasive |
| Study Sponsor ICMJE | NuVasive |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | NuVasive |
| Verification Date | May 2013 |
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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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