Advanced

Randomized radio stereometric study comparing osteogenic protein-1 (BMP-7) and autograft bone in human noninstrumented posterolateral lumbar fusion - 2002 Volvo Award in Clinical Studies

Johnsson, Ragnar LU ; Strömqvist, Björn LU and Aspenberg, Per (2002) In Spine 27(23). p.2654-2661
Abstract
Study Design. Randomized efficacy trial comparing two types of noninstrumented posterolateral fusion between L5 and S1 in patients with L5 spondylolysis and vertebral slip less than 50%, as evaluated by radiosterometric analysis. Objective. To determine whether osteogenic protein-1 (BMP-7) in the OP-1 Implant yields better stabilizing bony fusion than autograft bone. Summary of Background Data. Animal studies of osteoinductive proteins in noninstrumented posterolateral fusions have shown high fusion rates. No similar conclusive study on humans has been performed. Methods. For this study, 20 patients were randomized to fusion with either OP-1 Implant or autograft bone from the iliac crest, 10 in each group. The patients were instructed to... (More)
Study Design. Randomized efficacy trial comparing two types of noninstrumented posterolateral fusion between L5 and S1 in patients with L5 spondylolysis and vertebral slip less than 50%, as evaluated by radiosterometric analysis. Objective. To determine whether osteogenic protein-1 (BMP-7) in the OP-1 Implant yields better stabilizing bony fusion than autograft bone. Summary of Background Data. Animal studies of osteoinductive proteins in noninstrumented posterolateral fusions have shown high fusion rates. No similar conclusive study on humans has been performed. Methods. For this study, 20 patients were randomized to fusion with either OP-1 Implant or autograft bone from the iliac crest, 10 in each group. The patients were instructed to keep the trunk straight for 5 months after surgery with the aid of a soft lumbar brace. At surgery 0.8-mm metallic markers were positioned in L5 and the sacrum, enabling radiostereometric follow-up analysis during 1 year. The three-dimensional vertebral movements, as measured by radiostereometric analysis induced by positional change from supine posture to standing and sitting, were calculated with an accuracy of 0.5 to 0.7 mm and 0.5degrees to 2.0degrees. Conventional radiography was added. Results. No significant difference was noted between the radiostereometric and radiographic results of fusion with the OP-1 Implant and fusion with autograft bone. There was a significant relation between reduced vertebral movements and better bone formation. No adverse effects of the OP-1 Implant occurred. Persistent minor pain at the iliac crest was noticed in one patient. Conclusions. There was no significant difference between the two fusion versions. Thus, the OP-1 Implant did not yield better stabilizing bony fusion than autograft bone. (Less)
Please use this url to cite or link to this publication:
author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
randomized, study, vertebral movements, radiostereometric analysis, posterolateral lumbar fusion, noninstrumented, autograft bone, bone morphogenetic protein-7
in
Spine
volume
27
issue
23
pages
2654 - 2661
publisher
Lippincott Williams & Wilkins
external identifiers
  • pmid:12461391
  • wos:000179680000003
ISSN
0362-2436
language
English
LU publication?
yes
id
c9f5cf14-5ad7-449f-bb6b-294a5b462680 (old id 321478)
date added to LUP
2007-10-31 13:21:59
date last changed
2016-04-16 03:38:40
@article{c9f5cf14-5ad7-449f-bb6b-294a5b462680,
  abstract     = {Study Design. Randomized efficacy trial comparing two types of noninstrumented posterolateral fusion between L5 and S1 in patients with L5 spondylolysis and vertebral slip less than 50%, as evaluated by radiosterometric analysis. Objective. To determine whether osteogenic protein-1 (BMP-7) in the OP-1 Implant yields better stabilizing bony fusion than autograft bone. Summary of Background Data. Animal studies of osteoinductive proteins in noninstrumented posterolateral fusions have shown high fusion rates. No similar conclusive study on humans has been performed. Methods. For this study, 20 patients were randomized to fusion with either OP-1 Implant or autograft bone from the iliac crest, 10 in each group. The patients were instructed to keep the trunk straight for 5 months after surgery with the aid of a soft lumbar brace. At surgery 0.8-mm metallic markers were positioned in L5 and the sacrum, enabling radiostereometric follow-up analysis during 1 year. The three-dimensional vertebral movements, as measured by radiostereometric analysis induced by positional change from supine posture to standing and sitting, were calculated with an accuracy of 0.5 to 0.7 mm and 0.5degrees to 2.0degrees. Conventional radiography was added. Results. No significant difference was noted between the radiostereometric and radiographic results of fusion with the OP-1 Implant and fusion with autograft bone. There was a significant relation between reduced vertebral movements and better bone formation. No adverse effects of the OP-1 Implant occurred. Persistent minor pain at the iliac crest was noticed in one patient. Conclusions. There was no significant difference between the two fusion versions. Thus, the OP-1 Implant did not yield better stabilizing bony fusion than autograft bone.},
  author       = {Johnsson, Ragnar and Strömqvist, Björn and Aspenberg, Per},
  issn         = {0362-2436},
  keyword      = {randomized,study,vertebral movements,radiostereometric analysis,posterolateral lumbar fusion,noninstrumented,autograft bone,bone morphogenetic protein-7},
  language     = {eng},
  number       = {23},
  pages        = {2654--2661},
  publisher    = {Lippincott Williams & Wilkins},
  series       = {Spine},
  title        = {Randomized radio stereometric study comparing osteogenic protein-1 (BMP-7) and autograft bone in human noninstrumented posterolateral lumbar fusion - 2002 Volvo Award in Clinical Studies},
  volume       = {27},
  year         = {2002},
}