Surgeon Resources & Scientific Data

Clinical Research

Rigorous clinical trials, peer-reviewed evidence, and regulatory-certified data validating orthopedic and spinal innovations for global healthcare procurement.

Evidence-Driven Medical Technology

At Orthofix, clinical research forms the bedrock of our medical device development. We are committed to generating high-level scientific evidence to support our broad portfolio of spinal reconstruction, bone growth therapy, biologic substitutes, and limb restoration systems. Our international team of clinical research professionals collaborates with global medical institutions to execute rigorous investigational plans compliant with global regulatory standards including US FDA Investigational Device Exemptions (IDE) and EU MDR certification.

500+
Peer-Reviewed Publications
40+
Years Clinical Rigor
FDA & CE
Regulatory Validation
70+
Global Clinical Sites

Clinical Evidence & Research Programs

Explore comprehensive multi-center research, post-market surveillance data, and investigator-initiated scientific studies engineered for hospital procurement authorities and surgical specialists.

Surgeon reviewing clinical evidence and medical research documentation
Clinical Data

Clinical Evidence by Therapeutic Area

Discover published clinical trial results across spinal fusion, bio-materials, non-invasive electromagnetic therapies, and extremity reconstruction. Our clinical studies demonstrate validated fusion success rates, reduced surgical complications, and accelerated bone healing across international patient populations.

Published Data: Spine & Orthopedics Peer-Reviewed Validation
Medical research team conducting clinical investigation in laboratory environment
Research Collaboration

Investigator-Initiated Research Program

In addition to company-sponsored IDE trials, Orthofix actively supports independent clinical investigators worldwide. We provide competitive scientific grants, protocol consultation, and technical resources to advance biomechanical engineering, osteogenic research, and minimally invasive surgical techniques.

Global Grant Support Independent Clinical Studies

Regulatory Compliance & OEM Standards

For international healthcare distributors, hospital networks, and surgical centers, quality assurance is paramount. Orthofix clinical research adheres to stringently monitored GCP (Good Clinical Practice) protocols and international regulatory frameworks.

Every clinical dataset provides reliable, verifiable outcomes that empower hospital tender committees and international procurement officers to make confident purchasing decisions.

  • US FDA 510(k), PMA, and IDE regulatory approval compliance
  • European Union Medical Device Regulation (EU MDR 2017/745) certified
  • ISO 13485 quality system certification across global manufacturing facilities
  • Post-Market Clinical Follow-up (PMCF) registries ensuring long-term safety

Scientific Rigor for Global Partners

Our clinical operations team supports healthcare partners with technical dossiers, clinical evaluation reports (CER), health economic data, and surgical technique guides designed to streamline product registration and hospital adoption.

Verified Clinical Performance & Safety

Partner with Orthofix Clinical Research

Interested in accessing full clinical study reports, discussing distribution opportunities, or participating in ongoing clinical trials? Connect directly with our global medical operations team.

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