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