OSTEOAMP Lumbar Fusion Intra-Patient Controlled Study

NARecruitingINTERVENTIONAL
Enrollment

101

Participants

Timeline

Start Date

May 6, 2022

Primary Completion Date

October 31, 2024

Study Completion Date

October 31, 2025

Conditions
Lumbar Spine DiseaseLumbar SpondylolisthesisLumbar Spine InstabilityLumbar SpondylosisDegenerative 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.

Trial Locations (9)

23235

RECRUITING

OrthoVirginia, Richmond

26506

RECRUITING

West Virginia University, Morgantown

37209

RECRUITING

Tennessee Orthopaedic Alliance, Nashville

42001

RECRUITING

Orthopaedic Institute of Western Kentucky, Paducah

67226

RECRUITING

Kansas Joint and Spine Specialists, Wichita

71101

ACTIVE_NOT_RECRUITING

Spine Institute of Louisiana, Shreveport

78746

RECRUITING

Austin Neurosurgeons, Austin

06510

RECRUITING

Yale University, New Haven

02120

RECRUITING

New England Baptist Hospital, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bioventus LLC

INDUSTRY