NCT03438747 is a NA clinical trial of P-15L Bone Graft in Degenerative Disc Disease, sponsored by CeraPedics, Inc.

Who is sponsoring NCT03438747?

NCT03438747 is sponsored by CeraPedics, Inc.

What drugs are being tested in NCT03438747?

Interventions in NCT03438747: P-15L Bone Graft, Local autologous bone in a TLIF with Instrumentation.

What condition does NCT03438747 study?

NCT03438747 studies Degenerative Disc Disease.

Is NCT03438747 still recruiting?

NCT03438747 is currently active, enrolled. Last updated 6 October 2025.

Last reviewed 2025-10-06 · How we verify

NCT03438747

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled NA Last updated 6 October 2025

What this trial tests

NA trial testing P-15L Bone Graft in Degenerative Disc Disease in 290 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

24 April 2018

Primary endpoint
28 February 2028

28 February 2028

Quick facts

Lead sponsor	CeraPedics, Inc
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	290
Start date	24 April 2018
Primary completion	28 February 2028
Estimated completion	28 February 2028
Sites	34 locations across United States

Drugs / interventions tested

P-15L Bone Graft
Local autologous bone in a TLIF with Instrumentation

Conditions studied

Degenerative Disc Disease — all drugs for Degenerative Disc Disease →

Sponsor

CeraPedics, Inc

Who can join

Adults 22 to 80, any sex, with Degenerative Disc Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Bone Healing Gone Wrong: Pathological Fracture Healing and Non-Unions-Overview of Basic and Clinical Aspects and Systematic Review of Risk Factors.
Saul D, Menger MM, Ehnert S, Nüssler AK, et al · · 2023 · cited 29× · PMID 36671657 · DOI 10.3390/bioengineering10010085
P-15 Peptide Enhanced Bone Graft in Transforaminal Lumbar Interbody Fusion: A Randomized, Controlled, Investigational Device Exemption Study Demonstrating Improved Composite Clinical Success.
Harrop JS, O'Toole JE, Steinmetz MP, Sasso RC, et al · · 2026 · cited 1× · PMID 41307132 · DOI 10.1097/brs.0000000000005579
P-15 Peptide Enhanced Bone Graft Improves Time to Fusion in Transforaminal Lumbar Interbody Fusion: A Randomized, Controlled, Investigational Device Exemption Study.
Harrop JS, Steinmetz MP, O'Toole JE, Chaput CD, et al · · 2026 · cited 1× · PMID 41307110 · DOI 10.1097/brs.0000000000005580

Verify or expand the search:

Other recruiting trials for Degenerative Disc Disease

Currently open trials in the same condition.

NCT07254806 — A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Level, Symptomatic Mild to · Phase 3 · recruiting
NCT04679844 — Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Au · NA · recruiting
NCT06704919 — Conduit Cages and Fibergraft BG Putty · recruiting
NCT06053242 — Safety, Tolerability, and Effectiveness of Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Ba · Phase 1, PHASE2 · recruiting
NCT03810573 — Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03438747 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by CeraPedics, Inc
Last refreshed: 6 October 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03438747.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing