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COMPLETED NA

Interbody Spacers With map3® Cellular Allogeneic Bone Graft in Anterior or Lateral Lumbar Interbody Fusion

NCT02628210 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 30 participants
Start Date 2016-02
Est. Completion 2020-06
Phase NA

Sponsor

RTI Surgical

4 total trials

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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is RTI Surgical, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02628210 reports 3 study locations spanning 2 distinct geographic areas — top geographies include New York, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02628210?

The interventions under investigation include: map3® Cellular Allogeneic Bone Graft (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02628210?

This trial is sponsored by RTI Surgical, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial