On the basis of our experience, proficiency with the use of C1-LMS screw fixation greatly enhances the ability to manage complex atlantoaxial or craniocervical pathologies with low morbidity. This technique should be considered an excellent adjunct or alternative to transarticular screw fixation.
ObjectThe 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.MethodsThe 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.ConclusionsThe OP-1 putty appears to be safe and effective in promoting spinal arthrodesis in patients in whom adverse medical risk factors exist.
ObjectThe 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.MethodsOutcome 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.ResultsThe 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.ConclusionsOur 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.
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