Randomized and self-controlled study with anterior lumbar interbody fusion in a porcine model.
To determine the osteoinductive potential of an equine bone protein extract in anterior interbody spinal fusion.
Interbody spinal fusion with bone graft transplantation is a common spine procedure. Complications related to bone graft harvesting are still a major concern. Equine demineralized bone matrix has been reported to be osteoinductive. However, the application of equine bone protein extract in spine fusion has not been documented. In this experiment, we evaluated equine bone protein extract in a porcine spinal fusion model.
Due to their size and availability, we chose 12 normal Danish landrace pigs, each weighing 50 kg, as our experimental animals. Lumbar spine interbody fusion of L3/4, L4/5 using titanium alloy cages and pedicle screws instrumentation was performed on each pig. Cages packed with either autograft or equine bone protein extract (COLLOSS® E; OSSACUR AG, Oberstenfeld, Germany) were randomly assigned to the 2 levels anteriorly. The pigs were followed for 3 months. After sacrifice, radiograph, microcomputed tomography, and histomorphometry were used to evaluate the spine segments.
All pigs went through the observation without major complications. Radiograph examination after 12 weeks revealed no implant breakage, loosening, or spinal deformity. Microcomputed tomography scanning showed that cages with COLLOSS® E had the same fusion rate (11/12) as those with autograft. Three-dimensional evaluation from microcomputed tomography found a significant difference only in trabecular thickness; trabeculae from COLLOSS® E-filled cages were much thinner (P = 0.04). Histologic evaluations demonstrated longitudinally formed bone trabeculae in both autograft and COLLOSS® E-filled cages. Bone volume calculation from histomorphometry correlates well with that from microcomputed tomography results (R = 0.5; P = 0.01).
In this porcine model, COLLOSS® E is as effective as autograft for anterior spinal fusion.
Equine bone protein extract was tested as bone graft substitute in a porcine anterior spine fusion model. After 3 months of observation, equine bone protein extract achieved the same fusion rate and percentage of new bone formation as autogenous iliac bone graft in this animal model.
From the *Orthopaedic Research Laboratory, Orthopaedic Department E, Aarhus University Hospital, Aarhus, Denmark; and †OSSACUR AG, Oberstenfeld, Germany.
Acknowledgment date: July 19, 2006. First revision date: August 29, 2006. Second revision date: September 20, 2006. Acceptance date: September 22, 2006.
The device(s)/drug(s) that is/are the subject of this manuscript is/are not FDA-approved for this indication and is/are not commercially available in the United States.
Corporate/Industry funds were received in support of this work. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript.
Address correspondence and reprint requests to Haisheng Li, MD, PhD, Orthopaedic Research Laboratory, Orthopaedic Department E, Aarhus University Hospital, Nørrebrogade 44, 8000 Aarhus C, Denmark; E-mail: email@example.com