Randomized radiostereometric study comparing osteogenic protein-1 (BMP-7) and autograft bone in human noninstrumented posterolateral lumbar fusion: 2002 Volvo Award in clinical studies.
METHODS
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 radiostereometric analysis.


OBJECTIVE
To determine whether osteogenic protein-1 (BMP-7) in the OP-1 Implant yields better stabilizing bony fusion than autograft bone.


BACKGROUND
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 0.5 degrees to 2.0 degrees. 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.
Johnsson
Ragnar
R
Department of Orthopedics, Lund University Hospital, Lund, Sweden. ragnarjohnsson@spray.se
Strömqvist
Björn
B
Aspenberg
Per
P
D000328:Adult; D001363:Awards and Prizes; D001416:Back Pain / Q000209:etiology / Q000517:prevention & control; D055419:Bone Morphogenetic Protein 7; D019485:Bone Morphogenetic Proteins / Q000627:therapeutic use*; D016025:Bone Transplantation / Q000009:adverse effects; D004343:Drug Implants / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007085:Ilium / Q000637:transplantation; D021621:Imaging, Three-Dimensional; D008159:Lumbar Vertebrae / Q000000981:diagnostic imaging* / Q000187:drug effects* / Q000601:surgery; D008297:Male; D008875:Middle Aged; D010012:Osteogenesis / Q000187:drug effects; D019736:Prostheses and Implants / Q000009:adverse effects; D011859:Radiography; D012086:Reoperation; D012445:Sacrococcygeal Region; D013123:Spinal Fusion / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D013169:Spondylolysis / Q000601:surgery; D016212:Transforming Growth Factor beta; D014182:Transplantation, Autologous; D016896:Treatment Outcome
C525819:BMP7 protein, human; D055419:Bone Morphogenetic Protein 7; D019485:Bone Morphogenetic Proteins; D004343:Drug Implants; D016212:Transforming Growth Factor beta