The roles of funding source, clinical trial outcome, and quality of reporting in orthopedic surgery literature.

Compared with nonfunded or peer-reviewed funded projects, industry-sponsored clinical trials have traditionally been associated with more positive results. This relationship has been extensively studied in the nonsurgical literature. Although a few authors have addressed specialties, little has been reported on orthopedic clinical trials and their association with funding, study outcome, and efforts to reduce bias after randomization across journals of multiple subspecialties. For the study reported here, we selected 5 major orthopedic subspecialty journals: Journal of Bone and Joint Surgery (American Volume), Spine, Journal of Arthroplasty, Journal of Orthopaedic Trauma, and American Journal of Sports Medicine. We chose a 2-year limit for investigation (2002-2004); included all original randomized clinical trials reported in these 5 journals; and examined these trials for their study design, funding source, outcome, bias potential, and conclusion reached. Support for the 100 eligible orthopedic clinical trials was stated as coming from industry (26 trials, 26%), nonprofit sources (19 trials, 19%), and mixed sources (5 trials, 5%); no support was stated in 46 trials (46%), and support was not reported in 4 trials (4%). Of the 26 trials reporting industry support, 22 (85%) were graded as indicating an outcome favorable to the new treatment. The association between industry funding and favorable outcome was strong and significant (P<.001). In almost half of the studies reported in Journal of Bone and Joint Surgery and Spine, measures taken to reduce bias were not documented.

Comprehensive analysis of cantilever, translational, and modular corrective techniques in adults with scoliosis treated with surgery to the sacropelvis.

BACKGROUND: The treatment of adults with scoliosis has been the source of debate over the last several decades. Pain associated with curve progression and decompensation is the most common presenting scenario and surgical management is often indicated. Correction of these deformities may involve long segment fusions to the sacrum and pelvis. Most authors have reported high rates of complications associated with this procedure. There remains little consensus with regard to the treatment of this challenging condition. PURPOSE: The purpose of this study was to evaluate the clinical and radiographic outcomes of patients treated with long fusions to the sacrum and pelvis using third generation instrumentation techniques. These included the use of cantilever, translational, and modular corrective techniques. METHODS: Inpatient and outpatient charts were reviewed for 97 patients (89 women and 8 men). The average age was 55 years (27 to 78 y). The information obtained included patient age, sex, comorbidities, perioperative complications, and long-term clinical outcome. Standing radiographic coronal and sagittal measurements were recorded preoperatively, immediately postoperatively, and at the most recent follow-up visit. RESULTS: Eighty-nine patients underwent combined anterior and posterior surgery, whereas 8 patients were treated with posterior-only procedures. Two patients had fixation to the sacrum without extension into the ilium. Structural curves averaged 53 degrees preoperatively, 32 degrees postoperatively, and 33 degrees at follow-up. Thoracic kyphosis averaged +36 degrees preoperatively, +39 degrees postoperatively, and +46 degrees at follow-up. Lumbar lordosis averaged -41 degrees preoperatively, -48 degrees postoperatively, and -48 degrees at follow-up. Coronal imbalance averaged 2.9 cm preoperatively, 2.4 cm postoperatively, and 2.3 cm at follow-up. Sagittal imbalance averaged 6.8 cm preoperatively, 2.9 cm postoperatively, and 3.6 cm at follow-up. Major complications included pseudarthrosis (10%), deep infection (13%), painful iliac fixation (20%), neurologic injury (6%), need for some form of revision surgery (39%), chronic severe pain (2%), pulmonary embolism (2%), and deep venous thrombosis (2%). There were no permanent neurologic injuries or deaths related to the surgery.

Pott disease in the thoracolumbar spine with marked kyphosis and progressive paraplegia necessitating posterior vertebral column resection and anterior reconstruction with a cage.

STUDY DESIGN: Case report. OBJECTIVES: To report on a patient with Pott disease, progressive neurologic deficit, and severe kyphotic deformity, who had medical treatment fail and required posterior/anterior decompression with instrumented fusion. Treatment options will be discussed. SUMMARY OF BACKGROUND DATA: Tuberculous spondylitis is an increasingly common disease worldwide, with an estimated prevalence of 800,000 cases. METHODS: Surgical treatment consisting of extensive posterior decompression/instrumented fusion and 3-level posterior vertebral column resection, followed by anterior debridement/fusion with cage reconstruction. RESULTS: Neurologic improvement at 6-month follow-up (Frankel B to Frankel D), with evidence of radiographic fusion. CONCLUSIONS: A 70-year-old patient with progressive Pott paraplegia and severe kyphotic deformity, for whom medical treatment failed is presented. A posterior vertebral column resection, multiple level posterior decompression, and instrumented fusion, followed by an anterior interbody fusion with cage was used to decompress the spinal cord, restore sagittal alignment, and debride the infection. At 6-month follow-up, the patient obtained excellent pain relief, correction of deformity, elimination of the tuberculous foci, and significant recovery of neurologic function.

Efficacy of osteogenic protein-1 in a challenging multilevel fusion model.

STUDY DESIGN: A therapeutic study compared the influence of osteogenic protein-1 to autograft and collagen carrier in multilevel sheep spine fusions. OBJECTIVE: To evaluate the efficacy of osteogenic protein-1 compared to autograft and collagen carrier in achieving fusion in a challenging multilevel lumbar spine ovine model. SUMMARY OF BACKGROUND DATA: Bone morphogenetic proteins can successfully augment spinal fusion. To date, all the preclinical and clinical studies using bone morphogenetic proteins have evaluated single-level fusion. In practice, multiple level fusions are commonly required for various conditions, like spinal deformity. METHODS: Eighteen sheep underwent three-level spine fusion. Six sheep were treated with osteogenic protein-1 and its carrier, autograft, or with the carrier alone. Specimens were analyzed for evidence of fusion by palpation, radiographic and histologic analysis, and biomechanical testing. RESULTS: Manual palpation testing for the presence of fusion showed none of the specimens fused all three levels or fused at the lumbosacral junction. No statistically significant difference was found between the osteogenic protein-1 and autograft groups' fusion rates based on radiographic grading (P = 0.65) or biomechanical testing. Histologic analysis showed no qualitative difference in bone morphology or cellularity of fusion masses when comparing the autograft and osteogenic protein-1 specimens. CONCLUSIONS: No model before this exists that tests the efficacy of bone morphogenic proteins in as challenging an environment. Extrapolation of single-level preclinical and clinical studies with bone morphogenic proteins for use in multilevel fusion requires careful review. Autograft and osteogenic protein-1 had similar rates of fusion. A high rate of nonunion is seen with this multiple level fusion to the sacrum using autograft or osteogenic protein-1. The biologic enhancement with osteogenic protein-1 is not able to overcome this mechanically rigorous model.

Thoracic vertebral body exostosis as a cause of myelopathy in a patient with hereditary multiple exostoses.

The posterior thoracic vertebral body appears to be a novel origin for an exostosis causing myelopathy. A patient with hereditary multiple exostoses and myelopathy caused by an exostosis originating from the posterior aspect of the T5 vertebral body was treated with a staged anterior decompression/corpectomy and posterior spinal fusion. The patient had near-complete resolution of his myelopathy immediately after undergoing removal of the exostosis through a right-sided lateral thoracotomy approach. This was a unique origin for an exostosis causing spinal cord compression in a patient with hereditary multiple exostoses. The delivery of the exostosis was performed en bloc during the anterior decompression and corpectomy portion of the surgery. This resulted in the expected favorable outcome.