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Preneshlin V. Govender, Yoga R. Rampersaud, Lynda Rickards, and Michael G. Fehlings

Object

The safety and effectiveness of osteogenic protein (OP)–1 putty (recombinant human bone morphogenetic protein–7) in promoting fusion in complex spinal cases was studied in nine cases.

Methods

The authors prospectively evaluated nine patients requiring spinal fusion in whom there were medical risk factors that would inhibit osseous fusion. Intraoperatively the OP-1 putty mixed with autologous bone was placed at the fusion site. Outcome measurement instruments were used to provide information on patient demographics, comorbidities, and pain. The Short Form (SF)–36 questionnaire and Oswestry Disability Index (ODI) were administered pre- and postoperatively. All patients underwent routine radiography of the surgery site during follow-up examination.

The age of the five women and four men ranged from 21 to 74 years (mean height 1.6 m, mean weight 76.7 kg). Risk factors included mucopolysaccharide syndrome, adrenal insufficiency, rheumatoid arthritis with chronic corticosteroid use, morbid obesity, and heavy smoking. Surgery, which consisted of five cervical and four lumbar procedures, including intradural surgery in three patients, was uneventful in all cases without perioperative complication. The follow-up period ranged from 1 to 15 months (mean 5.22 months). The ODI score changed from severe disability (mean 46.89) pre-operatively to minimal and moderate disability (mean 34.56) postoperatively. The SF-36 survey showed overall improved mental and physical health scores. Fusion was present in all patients with greater than 3 months follow up.

Conclusions

The OP-1 putty appears to be safe and effective in promoting spinal arthrodesis in patients in whom adverse medical risk factors exist.

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Sheila K. Singh, Lynda Rickards, Ronald I. Apfelbaum, R. John Hurlbert, Dennis Maiman, and Michael G. Fehlings

Object. Stabilization of the craniocervical junction (CCJ) remains a significant challenge. In this multicenter study, the authors present the results of an evaluation of a precontoured titanium implant, the Ohio Medical Instruments (OMI) Loop, for craniocervical fixation.

Methods. In this multicenter retrospective study the authors evaluated 30 patients (16 female, 14 male; mean age 53.8 years) with rheumatoid arthritis (15 cases), traumatic occipitoatlantoaxial instability (six cases), congenital vertebral anomalies (two cases), instability due to basilar invagination in the setting of Chiari malformation (two cases), or Down syndrome (one case), tumor (one case), os odontoideum (two cases), and pseudarthrosis/other (one case), who underwent OMI Loop—assisted occipitocervical reconstruction. The mean follow-up period was 25.4 months (range 6–60 months).

A solid reconstruction was achieved in 29 of 30 cases; there was only one case of hardware failure requiring reoperation. Noncritical hardware failure occurred in two patients in whom partial occipital screw backout occurred but did not necessitate reoperation. There were no perioperative neurological complications. One patient (3.3%) experienced a delayed postoperative worsening of myelopathy at 1 year that resolved with further surgery. Postoperatively, in 66.6% of patients the degree of myelopathy remained stable (as measured by American Spinal Injury Association [ASIA] scores), whereas 30% improved by one or more ASIA grade. The rate of osseous fusion was 96.6% at a mean follow-up period of 25.4 months.

Conclusions. The authors found that the OMI Loop is a versatile precontoured occipitocervical fixation device that can be applied to a wide range of CCJ lesions. It provides excellent immediate rigid fixation of the CCJ, a high rate of osseous fusion, and a low rate of hardware failure.