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ASTM Selected Technical Papers
Spinal Implants: Are We Evaluating Them Appropriately?
By
MN Melkerson, M.S.
MN Melkerson, M.S.
1
Symposium chairman and co-editor
;
Food Drug Administration Center for Devices and Radiological Health Office of Device Evaluation
?
9200 Corporate Boulevard Rockville, MD 20850
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JS Kirkpatrick, M.D.
JS Kirkpatrick, M.D.
2
Symposium co-chairman and co-editor
;
University of Alabama, Birmingham and Birmingham Veterans Administration Medical Center
?
940 Faculty Office Tower 510 20th Street South Birmingham, Alabama 35294
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S Griffith, Ph.D.
S Griffith, Ph.D.
3
Symposium co-chairman and co-editor
;
Centerpulse Spine-Tech Division
?
7375 Bush Lake Road Minneapolis, MN 55439
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ISBN-10:
0-8031-3463-0
ISBN:
978-0-8031-3463-8
No. of Pages:
246
Publisher:
ASTM International
Publication date:
2003

A leading cause for reoperation in patients with idiopathic scoliosis receiving posterior instrumentation and arthrodesis is Late Operative Site Pain (LOSP), with corrosion at the transverse connection site being a common observation. Clinically, a consecutive series of 55 adolescent idiopathic scoliosis patients with Isola Drop Entry Transverse Rod Connector's (DETCs) was compared with an earlier consecutive series of 97 having Isola Threaded Transverse Rod Connectors (TRCs). Both groups were less than 21 years of age, with TRC average follow-up 87 months and DETC 32 months. Kaplan-Meier survivorship analysis, utilizing implant removal for LOSP, was performed on both groups. Biomechanically, axial and torsional gripping capacity tests were performed on the DETC and TRC interconnections to the longitudinal rod. The axial gripping capacity was 1164 and 1191 N for the two DETC connector components versus 363 N for the TRC connector component. Correspondingly the torsional gripping capacity was 4.1 and 4.7 Nm compared to 1.3 Nm. The Kaplan-Meier probability of reoperation for LOSP by 60 months was 4.7% in the TRC group compared to 0% for DETC (p = 0.3993). Seven TRC patients underwent removal for LOSP versus zero for DETC (p = 0.0504). The stronger DETC interconnections possibly correlate with a decreased incidence of LOSP.

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