Spinal fusion surgery is an important treatment for various spinal disorders including degenerative disc disease, traumatic injuries, and chronic instability. The procedure aims to permanently connect two or more vertebrae to eliminate motion and reduce pain.
However, as implant technology and biologic treatments for spinal fusion evolve, so does the need for accurate, reliable, and clinically relevant preclinical models. The models are essential for evaluating the performance, safety, and integration of new spine fusion devices and techniques before they ever reach the operating room.
Key Takeaways
- Spine surgery is a technically demanding procedure in orthopedics and its success depends heavily on highly effective devices and biologics.
- Preclinical models are essential for evaluating spine fusion devices and biologics.
- Relevant animal models and advanced imaging techniques allow researchers to simulate real-world surgical conditions and assess the success of fusion procedures over time.
Importance of Preclinical Models in Spine Fusion Development
Preclinical models serve as the critical proving ground for spinal fusion innovations. They simulate the physiological, mechanical, and biological environment of the human spine, allowing researchers to assess whether a device or biologic treatment can achieve effective bone fusion without complications.
Spine fusion is a complex healing process. It relies on the interaction between mechanical stabilization, biological activity, and host bone response. A preclinical model must capture all these elements to generate meaningful, translatable data that regulatory bodies and clinicians can trust.
Critical Elements of Spine Fusion Preclinical Studies
Preclinical models lead to effective spine fusion surgery through the following elements:
1. Anatomically Relevant Models
The choice of model is critical. Animal models such as sheep, pigs, or goats are often used because their spinal anatomy and biomechanics closely resemble those of humans. These models provide insight into how devices will perform in weight-bearing, dynamic environments, particularly at different spinal levels like the lumbar or cervical spine.
2. Implant Evaluation and Mechanical Testing
Preclinical models allow for testing of fusion cages, rods, plates, screws, and biologics in real anatomical settings. Researchers assess how well implants maintain spinal alignment, bear physiological loads, and resist loosening or migration. Mechanical assessments often include testing under compressive, torsional, and bending forces to simulate patient movement over time.
3. Fusion Assessment and Bone Integration
A key measure of success in spinal fusion is the quality and rate of bone bridging between vertebrae. Preclinical studies use radiographic imaging, CT scans, and histological analysis to determine whether true fusion has occurred. Histomorphometry provides detailed insights into new bone formation, vascularization, and implant-tissue interaction.
4. Biologic and Biomaterial Performance
Many spine fusion systems now incorporate biologic agents like bone graft substitutes, growth factors, or stem cells. Preclinical models are essential for evaluating the efficacy, safety, and inflammatory response to these materials. They help determine whether biologics enhance fusion rates or introduce new risks.
5. Chronic Studies and Longitudinal Data
Because spinal fusion is a process that unfolds over months, long-term preclinical studies are critical. Chronic models track how implants and biologics perform over time, identifying potential failure modes, degradation behavior, and complications such as pseudoarthrosis or adjacent segment disease.
The Role of Preclinical Research Partners
Working with a specialized preclinical research facility provides several advantages. These partners offer:
- Expertise in spine-specific surgical models
- Custom protocol development to meet regulatory and sponsor needs
- Integrated imaging, biomechanics, and histology services
- GLP-compliant studies designed for FDA or other global submissions
With access to experienced surgical teams and a proven track record in orthopedic and spine studies, preclinical research partners accelerate product development while ensuring data quality and reliability.
Partner With IBEX for Effective and Timely Preclinical Research
IBEX offers specialized preclinical models for spine fusion surgery, designed to evaluate implant performance, bone integration, and biologic efficacy in clinically relevant settings.
With short lead times and our orthopedic experts, we can guarantee to deliver the data you need to meet regulatory requirements and accelerate innovation. Schedule your consultation to learn more about our preclinical research capabilities.
