Document Detail

Intermediate follow-up after treatment of degenerative disc disease with the Bryan Cervical Disc Prosthesis: single-level and bi-level.
MedLine Citation:
PMID:  14673368     Owner:  NLM     Status:  MEDLINE    
STUDY DESIGN: Prospective, concurrently enrolled, multicenter trials of the Bryan Cervical Disc Prosthesis (Medtronic Sofamor Danek, Memphis, TN) were conducted for the treatment of patients with single-level and two-level (bi-level) degenerative disc disease of the cervical spine. OBJECTIVES: The studies were designed to determine whether new functional intervertebral cervical disc prosthesis can provide relief from objective neurologic symptoms and signs, improve the patient's ability to perform activities of daily living, decrease pain, and maintain stability and segmental motion. SUMMARY OF BACKGROUND DATA: The concept of accelerated degeneration of adjacent disc levels as a consequence of increased stress caused by interbody fusion of the cervical spine has been widely postulated. Therefore, reconstruction of a failed intervertebral disc with functional disc prosthesis should offer the same benefits as fusion while simultaneously providing motion and thereby protecting the adjacent level discs from the abnormal stresses associated with fusion. METHODS: Patients with symptomatic cervical radiculopathy and/or myelopathy underwent implantation with the Bryan prosthesis after a standard anterior cervical discectomy. At scheduled follow-up periods, the effectiveness of the device was characterized by evaluating each patient's pain, neurologic function, and radiographically measured range of motion at the implanted level. RESULTS: Clinical success for both studies exceeded the study acceptance criteria of 85%. At 1-year follow-up, the flexion-extension range of motion per level: Discectomy and implantation of the device alleviates neurologic symptoms and signs similar to anterior cervical discectomy and fusion. Radiographic evidence supports maintenance of motion. The procedure is safe and the patients recover quickly. At least 5 years of follow-up will be needed to assess the long-term functionality of the prosthesis and protective influence on adjacent levels.
Jan Goffin; Frank Van Calenbergh; Johannes van Loon; Adrian Casey; Pierre Kehr; Klaus Liebig; Bengt Lind; Carlo Logroscino; Rosella Sgrambiglia; Vincent Pointillart
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Spine     Volume:  28     ISSN:  1528-1159     ISO Abbreviation:  Spine     Publication Date:  2003 Dec 
Date Detail:
Created Date:  2003-12-15     Completed Date:  2004-10-13     Revised Date:  2009-07-09    
Medline Journal Info:
Nlm Unique ID:  7610646     Medline TA:  Spine (Phila Pa 1976)     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2673-8     Citation Subset:  IM    
Department of Neurosurgery, University Hospital, Leuven, Belgium.
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MeSH Terms
Cervical Vertebrae / radiography,  surgery*
Follow-Up Studies
Intervertebral Disk / surgery*
Middle Aged
Neurologic Examination
Prostheses and Implants*
Quality of Life
Spinal Diseases / diagnosis,  radiography,  surgery*

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

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