NCT05405374

OSTEOAMP Lumbar Fusion Intra-Patient Controlled Study

A Prospective, Randomized, Intra-Patient Controlled, Multi-Center Clinical Investigation Evaluating OSTEOAMP SELECT Fibers Versus Infuse Bone Graft as Autograft Substitute in Lumbar Fusion Procedures

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (estimated)
• Sponsor: Bioventus LLC · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The current study will collect clinical evidence for OSTEOAMP SELECT in spinal fusion procedures. In particular, the study will explore the use of OSTEOAMP SELECT as part of a lumbar interbody fusion (LIF) procedure of two lumbar motion segments between L2 to S1 in patients suffering from symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or mild degenerative scoliosis. Effectiveness will be based on the lumbar interbody fusion rate at the index levels assessed by a treatment-blinded independent reviewer at 12 months and 24 months. Safety will be evaluated by documenting the number and nature of all (serious) adverse events that may in any way be related to the surgical procedure or product. The complication rate will be compared to the rate in control populations from literature.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-05-06
• Primary completion: 2024-10-01
• Completion: 2025-10-01
• First posted: 2022-06-06
• Last updated: 2023-08-28

Locations

9 sites across 1 country: United States