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A pilot study evaluating the safety and efficacy of OP-1 Putty (rhBMP-7) as a replacement for iliac crest autograft in posterolateral lumbar arthrodesis for degenerative spondylolisthesis.

Abstract：

STUDY DESIGN:A prospective, randomized, controlled, multicenter clinical study was conducted. OBJECTIVE:To compare the clinical and radiographic outcomes of patients treated with OP-1 (BMP-7) Putty to autogenous iliac crest bone graft for one-level uninstrumented posterolateral fusion of the lumbar spine following decompressive laminectomy for the treatment of symptomatic degenerative spondylolisthesis with spinal stenosis. BACKGROUND:Preclinical studies have demonstrated that osteoinductive recombinant human osteogenic protein 1 in the form of OP-1 Putty is successful at achieving a posterolateral fusion in rabbits and dogs without any significant safety concerns. METHODS:Thirty-six patients with degenerative lumbar spondylolisthesis and symptoms of neurogenic claudication were randomized (2:1) to either OP-1 Putty (3.5 mg of OP-1 per side) or autogenous iliac crest bone graft for one-level uninstrumented posterolateral fusion following a decompressive laminectomy. Enrollment in the study was complete when 24 OP-1 Putty patients and 12 autograft patients had been randomized and treated. A patient administered Oswestry scale and SF-36 scale were used to determine clinical outcomes. Independent, blinded neuroradiologists reviewed both static and dynamic radiographs to determine fusion status. RESULTS:At the 1-year follow-up, 32 patients were available for clinical analysis and 29 patients were available for radiographic review. Clinical success as measured on the Oswestry scale was achieved by 18 of 21 (86%) OP-1 Putty patients and 8 of 11 (73%) autograft patients. SF-36 pain index scores showed similar results. Fourteen of 19 (74%) OP-1 Putty patients and 6 of 10 (60%) autograft patients achieved a successful posterolateral fusion fulfilling all fusion criteria. Of the 29 evaluable patients, 15 were both clinical and radiographic successes, 5 were radiographic successes but were clinical failures, 1 patient was both a radiographic and clinical failure, and 8 patients were radiographic failures but were clinical successes. No systemic toxicity, ectopic bone formation, recurrent stenosis, or other adverse events related to the OP-1 Putty implant were observed. CONCLUSION:Although the posterolateral spine is a challenging fusion environment in patients with degenerative spondylolisthesis, successful radiographic fusion was obtained using OP-1 Putty at a rate that was similar to autograft given the number of patients in this study. Importantly, there were no apparent adverse consequences related to the use of the OP-1 Putty implant in this patient population.

journal_name

Spine (Phila Pa 1976)

journal_title

Spine

authors

Vaccaro AR,Patel T,Fischgrund J,Anderson DG,Truumees E,Herkowitz HN,Phillips F,Hilibrand A,Albert TJ,Wetzel T,McCulloch JA

doi

10.1097/01.brs.0000137062.79201.98

keywords:

subject

Has Abstract

pub_date

2004-09-01 00:00:00

pages

1885-92

issue

eissn

0362-2436

issn

1528-1159

pii

00007632-200409010-00009

journal_volume

pub_type

临床试验,杂志文章,多中心研究,随机对照试验

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A pilot study evaluating the safety and efficacy of OP-1 Putty (rhBMP-7) as a replacement for iliac crest autograft in posterolateral lumbar arthrodesis for degenerative spondylolisthesis.