Design, Development, Funding, and Implementation of the CSRS Registry: A Prospective Multicenter Clinical Cervical...

Area of Science:

• Spine Surgery Research
• Clinical Data Registries
• Patient-Reported Outcomes

Background:

• Significant practice variation exists in cervical spine surgery.
• Randomized clinical trials have limitations in evaluating real-world patient populations and diverse surgical implants.
• A need exists for high-quality research on the safety and effectiveness of cervical spine procedures.

Purpose of the Study:

• To describe the design, development, and implementation of the Cervical Spine Surgery (CSRS) National Registry.
• To collect data for 1000 patients with cervical myelopathy and radiculopathy.
• To enable research on the safety and effectiveness of cervical spine surgeries and implants.

Main Methods:

• A prospective, national cervical spine surgery registry was established.
• Data collected included patient demographics, radiographic imaging, surgical approach, and implant details.
• Validated patient-reported outcome measures (PROMs) were collected from multiple clinical sites across the US.

Main Results:

• 1000 patients were enrolled, with 31% follow-up at 1 year.
• Patients diagnosed with radiculopathy, myelopathy, or both showed significant improvements in PROMs post-surgery.
• Key outcome scores (NDI, P-mJOA, CSDI, PROMIS-10 Physical Health) demonstrated statistically significant improvements at 1-year follow-up.

Conclusions:

• The CSRS Registry has successfully collected valuable clinical outcomes data.
• The collected data is being utilized for comparative effectiveness research.
• The registry facilitates evaluations of the long-term safety and effectiveness of spinal implants.