Document Detail

The effect of pedicle screw/plate fixation on lumbar/lumbosacral autogenous bone graft fusions in patients with degenerative disc disease.
MedLine Citation:
PMID:  7701397     Owner:  NLM     Status:  MEDLINE    
STUDY DESIGN: A prospective, multi-center Investigational Device Exemption Study was carried out in the United States using a pedicle screw and plate system to perform a fusion in patients with degenerative disc disease or spondylolisthesis. The patients' pain function, complications, and fusion status were evaluated and compared with literature controls. OBJECTIVES: To study the safety and efficacy of the ISF pedicle screw/plate system. This article focuses only on those study patients with degenerative disc disease treated with autogenous bone grafts and compares the results to those of similar patients treated without instrumentation, as reported in the literature. SUMMARY OF BACKGROUND DATA: Twenty-eight patients were in the subgroup studied--patients with degenerative disc disease who had fusions with autogenous bone graft. This study was conducted at four clinical sites with a 2-year follow-up. Patient follow-up was greater than 95% at all time points. METHODS: To be considered a patient with degenerative disc disease, radiographs had to demonstrate a collapse of the disc, the presence of bone erosion, or the compression of the vertebrae as the primary spinal abnormality. Spinal fusion must have been the recommended surgical treatment for discogenic pain. The fusion status was evaluated by the operating surgeon and an independent reviewer. RESULTS: After 2 years, this subset of patients (n = 28) with degenerative disc disease who had lumbar/lumbosacral fusion with autogenous bone graft was found to have a pseudarthrosis rate of 0%. Eight articles in the literature were found to be valid noninstrumented literature controls with which this subgroup could be compared. The average pseudarthrosis rate in the control group was 32%. CONCLUSIONS: A statistical analysis showed that patients with degenerative disc disease who underwent fusion without pedicle screw instrumentation were over 24 times more likely to have a pseudarthrosis than comparable patients implanted with a pedicle screw/plate system. Regarding the most important goal in performing a spinal fusion--fusion of the spine--the pedicle screw/plate system used in this study was shown to be a safe and efficacious method of facilitating fusion with autogenous bone graft for this patient population.
G W Wood; R J Boyd; T A Carothers; F L Mansfield; G R Rechtine; M J Rozen; C E Sutterlin
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Controlled Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Spine     Volume:  20     ISSN:  0362-2436     ISO Abbreviation:  Spine     Publication Date:  1995 Apr 
Date Detail:
Created Date:  1995-05-04     Completed Date:  1995-05-04     Revised Date:  2010-03-24    
Medline Journal Info:
Nlm Unique ID:  7610646     Medline TA:  Spine (Phila Pa 1976)     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  819-30     Citation Subset:  IM    
Campbell Clinic, Memphis, Tennessee, USA.
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MeSH Terms
Bone Plates*
Bone Screws*
Bone Transplantation*
Device Approval
Follow-Up Studies
Intervertebral Disk Displacement / surgery*
Lumbar Vertebrae / surgery*
Middle Aged
Postoperative Complications / epidemiology
Prospective Studies
Pseudarthrosis / epidemiology
Sacrum / surgery*
Spinal Fusion / instrumentation*
Spondylolisthesis / surgery*
Time Factors

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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