Demineralized Bone Matrix (DBM) for Spinal Fusion

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Spinal FusionAnterior Lumbar Interbody Fusion (ALIF) - Procedure
Eligibility
18+
All Sexes
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Study Summary

This trial is comparing two different types of bone grafts for lumbar interbody fusion surgery.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 12 months

12 months
Assessment of fusion for the DBM versus CBM cohorts

Trial Safety

Trial Design

2 Treatment Groups

Demineralized Bone Matrix (DBM)
1 of 2
Cellular Bone Matrix (CBM)
1 of 2

Active Control

40 Total Participants · 2 Treatment Groups

Primary Treatment: Demineralized Bone Matrix (DBM) · No Placebo Group · N/A

Demineralized Bone Matrix (DBM)
Procedure
ActiveComparator Group · 1 Intervention: Anterior Lumbar Interbody Fusion (ALIF) · Intervention Types: Procedure
Cellular Bone Matrix (CBM)
Procedure
ActiveComparator Group · 1 Intervention: Anterior Lumbar Interbody Fusion (ALIF) · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

SeaSpine, Inc.Lead Sponsor
8 Previous Clinical Trials
734 Total Patients Enrolled
Muwaffak Abdulhak, MDPrincipal InvestigatorHenry Ford Health System

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are at least 18 years of age.
You are physically and mentally able and willing to return for the scheduled follow up visits, follow post-operative instructions.