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Coflex PS3 Actual Conditions for Use Study

NCT02555280 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-01-05

No results posted yet for this study

Summary

A 2 and 5 year evaluation of clinical outcomes in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with additional stabilization using the coflex® Interlaminar Technology for FDA Actual Conditions of Use Study.

Conditions

  • Spinal Stenosis Lumbar

Interventions

DEVICE

coflex® Interlaminar Technology

Decompression plus coflex® Interlaminar Technology

PROCEDURE

Decompression

Decompression alone

Sponsors & Collaborators

  • MCRA

    collaborator INDUSTRY

  • Xtant Medical

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-09
Primary Completion
2024-09-30
Completion
2027-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02555280 on ClinicalTrials.gov