NCT01452022

Performance of Inductigraft in Spinal Fusion

A Prospective Open-label Non-randomdised Multi-centre Clinical Study to Evaluate the Performance of Inductigraft in Posterolateral Fusion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label non-randomised, prospective, post market study to evaluate the performance of Inductigraft (osteoinductive synthetic bone graft) in patients receiving posterolateral lumbar spine fusion through assessment of successful fusion at 12 months post operation using x-rays and CT scans. Quality of life questionnaires also used to assess clinical outcome measures such as pain and quality of life. Patients followed up for 24 months after surgery.

Conditions

• Degenerative Disk Disease
• Spinal Stenosis of Lumbar Region

Interventions

Type	Name	Description
DEVICE	Inductigraft	Synthetic bone graft

Timeline

• Start date: 2011-10-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2011-10-14
• Last updated: 2017-04-05

Locations

15 sites across 5 countries: Germany, Hungary, Ireland, Spain, United Kingdom