Use of osteogenic protein-1 in patients at high risk for spinal pseudarthrosis: a prospective cohort study assessing safety, health-related quality of life, and radiographic fusion. Invited submission from the Joint Section on Disorders of the Spine and Peripheral Nerves, March 2007.
OBJECTIVE
The capability of osteogenic protein (OP)-1 to induce bone formation has led to an increasing interest in its use in fusion surgery. This prospective study examines the safety and efficacy of OP-1 use in patients considered to be at a high risk for developing pseudarthrosis following reconstructive spinal surgery.


METHODS
Outcome measures included documentation of adverse events, radiographic evaluation of fusion by an independent musculoskeletal radiologist blinded to treatment, the Oswestry Disability Index (ODI), and the 36-Item Short Form Health Survey (SF-36). The health-related quality of life (HRQOL) assessments (ODI and SF-36) were given at baseline and at 3, 6, 12, 18, and 24 months after the surgical OP-1 implant.


RESULTS
The study consisted of 17 male and 13 female patients, with a mean age of 53 years (range 20-77 years). Fourteen patients underwent operations for cervical disease, and 16 for lumbar disease, with a median postoperative follow-up of 24 months (range 13-46 months). There were significant improvements in the physical health (from 28.7 +/- 1.5 to 34.2 +/- 3; p = 0.025) and mental health (from 43.7 +/- 2 to 47.5 +/- 3.1; p = 0.015) summary scores on the SF-36. The mean postoperative ODI score at 6, 9, 12, and 18 months was significantly lower than the baseline ODI score, after taking into consideration a 10-point measurement error (p = 0.0003, p = 0.003, p = 0.004, and p = 0.032, respectively). At 24 months, however, the differences in ODI scores were no longer significant. Of the 30 patients, 24 (80%) were deemed to have a solid fusion. There were no allergic reactions to OP-1 and no symptomatic postoperative hematomas.


CONCLUSIONS
Our results suggest that the use of OP-1 is safe and may contribute to high fusion rates, as demonstrated by radiographs, reduced levels of disability, and improved HRQOL in patients considered to be at a high risk for developing a nonunion after spinal reconstructive surgery.
Furlan
Julio C
JC
Division of Neurosurgery, Department of Surgery, University of Toronto, Ontario, Canada.
Perrin
Richard G
RG
Govender
Preneshlin V
PV
Petrenko
Yuriy
Y
Massicotte
Eric M
EM
Rampersaud
Yoga R
YR
Lewis
Stephen
S
Fehlings
Michael G
MG
D000328:Adult; D000368:Aged; D055419:Bone Morphogenetic Protein 7; D019485:Bone Morphogenetic Proteins / Q000627:therapeutic use*; D002574:Cervical Vertebrae; D015331:Cohort Studies; D005260:Female; D006304:Health Status; D006801:Humans; D008159:Lumbar Vertebrae; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011542:Pseudarthrosis / Q000000981:diagnostic imaging / Q000209:etiology / Q000517:prevention & control*; D011788:Quality of Life; D011859:Radiography; D013122:Spinal Diseases / Q000000981:diagnostic imaging / Q000601:surgery*; D013123:Spinal Fusion / Q000009:adverse effects*; D016896:Treatment Outcome
C525819:BMP7 protein, human; D055419:Bone Morphogenetic Protein 7; D019485:Bone Morphogenetic Proteins