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OSTEOAMP Lumbar Fusion Intra-Patient Controlled Study

NCT05405374 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2023-08-28

No results posted yet for this study

Summary

The objective of this clinical study is to compare OSTEOAMP SELECT Fibers to Infuse Bone Graft, in terms of effectiveness and safety, when used as a bone graft substitute in in skeletally mature patients qualified for 2-lumbar interbody fusion (LIF) by means of an intra-patient control model.

Conditions

  • Lumbar Spine Disease
  • Lumbar Spondylolisthesis
  • Lumbar Spine Instability
  • Lumbar Spondylosis
  • Degenerative Disc Disease

Interventions

OTHER

OSTEOAMP

OSTEOAMP SELECT Fibers (derived from human bone allograft) rehydrated with bone marrow aspirate (BMA) and combined with local autogenous graft for use in lumbar interbody fusion of the lumbar spine.

DEVICE

Infuse

The Infuse Bone Graft/Medtronic Interbody Fusion Device consists of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2, known as dibotermin alfa) placed on an absorbable collagen sponge (ACS). rhBMP-2 is the active agent in the Infuse Bone Graft component. The ACS is a soft, white, pliable, absorbent implantable matrix for rhBMP-2.

Sponsors & Collaborators

  • Bioventus LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-05-06
Primary Completion
2024-10-31
Completion
2025-10-31

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 NCT05405374 on ClinicalTrials.gov