Trial record 1 of 1 for:
archus orthopedics
Total Facet Arthroplasty System®(TFAS®) Clinical Trial
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ClinicalTrials.gov Identifier: NCT00418197 |
Recruitment Status
: Unknown
Verified February 2009 by Archus Orthopedics, Inc..
Recruitment status was: Active, not recruiting
First Posted
: January 4, 2007
Last Update Posted
: February 5, 2009
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Sponsor:
Archus Orthopedics, Inc.
Information provided by:
Archus Orthopedics, Inc.
Tracking Information | |||
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First Submitted Date ICMJE | January 2, 2007 | ||
First Posted Date ICMJE | January 4, 2007 | ||
Last Update Posted Date | February 5, 2009 | ||
Study Start Date ICMJE | August 2005 | ||
Primary Completion Date | Not Provided | ||
Current Primary Outcome Measures ICMJE |
The primary safety and efficacy evaluation endpoints to determine individual patient success are the Zurich Claudication Questionnaire (ZCQ), neurologic status, solid fusion for the control (spinal fusion) group. | ||
Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | Complete list of historical versions of study NCT00418197 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE |
Visual Analog Scales (VAS) for Leg and Back pain, SF-36 scores, radiographic measurements. | ||
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 | Total Facet Arthroplasty System®(TFAS®) Clinical Trial | ||
Official Title ICMJE | A Prospective and Randomized Controlled Trial to Evaluate the Safety and Effectiveness of Total Facet Arthroplasty in the Treatment of Degenerative Spinal Stenosis | ||
Brief Summary | The Archus Total Facet Arthroplasty System® (TFAS®) is a non-fusion spinal implant indicated for treatment of patients with moderate to severe spinal stenosis. TFAS® replaces the diseased facets following surgical removal. TFAS® offers the surgeon new options for treating spinal stenosis patients, enabling a more comprehensive decompression via complete removal of the facets. TFAS® also offers an alternative to rigid spinal fusion fixation enabling intervertebral motion. The clinical trial is intended to demonstrate restoration of stability and sagittal balance to the spine. TFAS® also eliminates the need for painful bone graft harvest from the patient's hip which may be required with fusion procedures. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase | Phase 3 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Device: Total Facet Arthroplasty System® (TFAS®) | ||
Study Arms | Not Provided | ||
Publications * | Not Provided | ||
* 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 | Unknown status | ||
Estimated Enrollment ICMJE |
450 | ||
Original Enrollment ICMJE | Same as current | ||
Study Completion Date | Not Provided | ||
Primary Completion Date | Not Provided | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 50 Years to 85 Years (Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Not Provided | ||
Removed Location Countries | United States | ||
Administrative Information | |||
NCT Number ICMJE | NCT00418197 | ||
Other Study ID Numbers ICMJE | PR0051 | ||
Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Not Provided | ||
Study Sponsor ICMJE | Archus Orthopedics, Inc. | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Archus Orthopedics, Inc. | ||
Verification Date | February 2009 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |