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Int J Spine Surg. 2015 Feb 3;9. doi: 10.14444/2002. eCollection 2015.

Prospective analysis of a new bone graft in lumbar interbody fusion: results of a 2- year prospective clinical and radiological study.

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1
Orthopaedic Surgery, Sint-Trudo ZiekenHuis, Sint- Truiden, Belgium.

Abstract

BACKGROUND:

This study examined the efficacy and safety of bone graft material ABM/P-15 (iFACTOR) for use in posterior lumbar interbody fusion. ABM/P-15 has been used safely for more than a decade in dental applications.

METHODS:

Forty patients underwent PLIF surgery, with each patient as control. Assessments up to 24 months included radiographs, CT scan, VAS, and ODI. Primary success criteria were fusion and safety.

RESULTS:

Intra-cage bridging bone occurred earlier with ABM/P-15 than autograft (97.73% vs. 59.09% at 6 months). On average pain decreased 29 points and function improved 43 points. Radio dense material outside the disk space occurred more frequently with ABM/P-15 than autograft, without clinical consequence.

CONCLUSIONS:

This study suggests that ABM/P-15 has equal or greater efficacy at 6 and 12 months. Pain improvements exceeded success criteria at all time points. Functional improvement exceeded success criteria at all time points.

CLINICAL RELEVANCE:

This study explores the safety and efficacy of an osteobiologic peptide enhanced bone graft material as a viable alternative to autograft and its attendant risks.

KEYWORDS:

ABM/P-15; P-15; PLIF; bone graft alternative; lumbar fusion; peptide

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