Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

December 6, 2024

Primary Completion Date

June 2, 2027

Study Completion Date

August 30, 2027

Conditions
Degenerative Disc DiseaseSpine FusionBack Pain
Interventions
DEVICE

MagnetOs Easypack Putty

MagnetOs Easypack Putty used standalone in instrumented posterolateral fusion, 5cc-15c per spine level at the randomized assigned side.

DEVICE

Demineralized Bone Matrix or Fibers mixed with local autograft bone

Demineralized Bone Matrix or Fibers (DBX or Grafton) mixed in a 1:1 vol% with local autologous bone graft used in instrumented posterolateral fusion, 5cc-15cc per level mixed with bone marrow aspirate/blood per spine level at the contralateral side.

Trial Locations (4)

19107

RECRUITING

Rothman Orthopaedic Institute, Philadelphia

37209

RECRUITING

Tennessee Orthopaedic Alliance, Nashville

63130

RECRUITING

The Washington University, St Louis

98104

RECRUITING

University of Washington, Seattle

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Simplified Clinical Data Systems, LLC

INDUSTRY

collaborator

Kuros BioSciences B.V.

INDUSTRY

lead

Kuros Biosurgery AG

INDUSTRY

NCT04679844 - Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion | Biotech Hunter | Biotech Hunter