European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society
-
Clinical Trial
A pilot safety and efficacy study of OP-1 putty (rhBMP-7) as an adjunct to iliac crest autograft in posterolateral lumbar fusions.
The ability of bone morphogenetic proteins (BMPs) to induce bone formation has led to an increasing interest in the potential for their use in fusion surgery. The purpose of this multi-center clinical pilot study was to evaluate the safety of one such BMP-osteogenic protein 1, in the form of OP-1 putty-combined with autograft for intertransverse process fusion of the lumbar spine in patients with symptomatic spinal stenosis and degenerative spondylolisthesis following spinal decompression. Twelve patients with spinal stenosis and degenerative lumbar spondylolisthesis underwent laminectomy and partial or complete medial facetectomy as required for decompression of the neural elements followed by intertransverse process fusion by placing iliac crest autograft and OP-1 putty between the decorticated transverse processes. ⋯ A successful fusion was observed in slightly over half the patients in this study, using stringent criteria without adjunctive spinal instrumentation. This study did not demonstrate the superiority of OP-1 combined with autograft over an autograft alone historical control, in which the fusion rate was approximately 45%. The lack of adverse events related to the OP-1 putty implant in this study is in agreement with other studies supporting the safety of bone morphogenetic proteins in spinal surgery.
-
Bony metastases are a frequent problem in elderly patients affected by cancer, and those with bony metastases involve the spine in approx. 50%. The most frequent spinal metastases (60%) are from breast, lung, or prostate cancer. The chance that an elderly patient (60-79 years old) is affected by bony metastases is four times higher in men and three times higher in women than a middle-aged patient (40-59 years old). ⋯ Surgical management shows the greatest improvement in pain reduction, but also in other domains of quality of life. Since prospective randomized studies comparing different treatment modalities for spinal metastases including surgery are not available and are ethically difficult to achieve, each case remains an interdisciplinary, shared decision making process for what is considered best for a patient or elderly patient. However, whenever surgery is an option, it should be planned before irradiation since surgery after irradiation has a significant higher complication rate.
-
Traditionally, spinal fusion has been denied to patients with scoliosis secondary to Duchenne's muscular dystrophy (DMD) when their forced vital capacity (FVC) is less than 30-40% of predicted values (PFVC). The reasons for this decision are a theoretically increased risk of adverse events from a prolonged anaesthetic and extensive surgery. This paper presents a retrospective analysis of 30 patients with DMD scoliosis who underwent posterior spinal fusion at the Royal National Orthopaedic Hospital. ⋯ One patient in each group required a temporary tracheotomy and there were nine complications in total. The post-operative stay for patients in each group was similar (24 days in the >30% group, 20 days in the <30% group) and the complication rate was comparable with other published series. We conclude that spinal fusion can be offered to patients with DMD even in the presence of a low FVC.
-
Disadvantages of thoracic posterior implants and developments in rod contouring in situ led to the design of a new spinal implant: the bipedicular spinal fixation device (BSF). The BSF is composed of two bifid hooks linked by a compression transverse connector and inserted into the costo-vertebral and costo-transverse joints. The aim of this biomechanical study was to determine the loading tolerance of the BSF. ⋯ The mean BMD estimated by DEXA was 0.557 g/cm(2). The BSF loading tolerance was compatible with the in situ rod contouring technique requirements when we considered posterior and lateral pull-out tests. The transversal compression test determined the appropriate and efficient BSF tightening force.