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NCT02628210 · ClinicalTrials.gov registry record · NA
Interbody Spacers With map3® Cellular Allogeneic Bone Graft in Anterior or Lateral Lumbar Interbody Fusion
A NA study of Degenerative Disc Disease and Spondylolisthesis, sponsored by RTI Surgical.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 3
- Study locations
NCT02628210 is a NA study of Degenerative Disc Disease and Spondylolisthesis that has completed, run by RTI Surgical. The registered enrollment target is 30 participants, below the 168-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (82% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT02628210, a NA study of Degenerative Disc Disease and Spondylolisthesis, has completed, sponsored by RTI Surgical.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a single-arm post-market study in patients requiring lumbar fusion using allograft interbody spacer in conjunction with map3® Cellular Allogeneic Bone Graft in patients with degenerative disc disease (DDD). This cohort study will enroll 80 patients total at up to 10 sites. After subjects have signed an informed consent, the baseline visit and examinations will be completed. Patients will be evaluated at 6 weeks, 3 months, 6 months, 12 months, and 24 month visit after surgery.
Conditions Studied
Interventions
- OTHER map3® Cellular Allogeneic Bone Graft
Study Locations (3)
New York
- Spine Surgery of Buffalo Niagara, LLC - Niagara Falls
- AXIS Neurosurgery and Spine of WNY, PLLC - Williamsville
Ohio
- Carl & Edyth Lindner Center for Research The Christ Hospital - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2016-02 |
| Est. Completion | 2020-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02628210
The ClinicalTrials.gov registry entry for NCT02628210 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 168-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (82% lower). The listed sponsor is RTI Surgical, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Degenerative Disc Disease appearing as the primary indexed condition, and to 1 intervention - of which map3® Cellular Allogeneic Bone Graft is the first listed.
NCT02628210 reports 3 study locations spanning 2 distinct geographic areas - top geographies include New York, Ohio.
Frequently Asked Questions
What is clinical trial NCT02628210 about?
NCT02628210 is a clinical study titled "Interbody Spacers With map3® Cellular Allogeneic Bone Graft in Anterior or Lateral Lumbar Interbody Fusion". This is a single-arm post-market study in patients requiring lumbar fusion using allograft interbody spacer in conjunction with map3® Cellular Allogeneic Bone Graft in patients with degenerative disc disease (DDD). This cohort study will enroll 80 patients total at up to 10 sites. After subjects hav...
What is the current status of trial NCT02628210?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2016-02. Estimated completion is 2020-06.
What conditions does trial NCT02628210 study?
This clinical trial studies the following conditions: Degenerative Disc Disease, Spondylolisthesis, Spondylosis.
What interventions are being tested in trial NCT02628210?
The interventions under investigation include: map3® Cellular Allogeneic Bone Graft (OTHER).
Who is sponsoring clinical trial NCT02628210?
This trial is sponsored by RTI Surgical, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02628210 being conducted?
This trial has 3 study locations across New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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