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P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation

NCT03438747 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2025-10-06

No results posted yet for this study

Summary

The aim of this trial is to evaluate if P-15L bone graft (investigational device) is not inferior in effectiveness and safety to local autologous bone (and allograft where necessary) as an extender (control device) when applied in instrumented transforaminal lumbar interbody fusion (TLIF) in subjects with degenerative disc disease (DDD). In addition to the general overall objective, a sub-group analysis will be performed on the high-risk subject population (tobacco use, obesity, diabetes), as previous studies have shown negative effects of smoking, obesity and diabetes on fusion and bone healing, increased peri/postoperative complications, and lower patient-reported outcome scores.

Conditions

  • Degenerative Disc Disease

Interventions

DEVICE

P-15L Bone Graft

The investigational group will be treated with P-15L in an instrumented TLIF

OTHER

Local autologous bone in a TLIF with Instrumentation

The active control group will be treated local autologous bone in an instrumented TLIF

Sponsors & Collaborators

  • CeraPedics, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-24
Primary Completion
2028-02-28
Completion
2028-02-28
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 NCT03438747 on ClinicalTrials.gov