NCT02250248

AttraX® Putty vs. Autograft in XLIF®

AttraX® Putty vs. Autograft in eXtreme Lateral Interbody Fusion (XLIF®): A Prospective Randomized Single-Center Evaluation of Radiographic and Clinical Outcomes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: NuVasive · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the clinical success of AttraX Putty as a bone graft substitute for autograft in XLIF procedures.

Detailed description

This is a single-center, prospective, randomized study. Subjects will be recruited from patients already under the Investigator's care who are indicated for XLIF with iliac crest bone graft (ICBG) autograft or AttraX Putty. To minimize bias, all consecutive patients at a given investigational site who meet eligibility requirements will be asked to consent to participate in the study whereby the biologic (ICBG autograft or AttraX Putty) will be randomly assigned. All subjects will be followed for 24 months following surgery to quantify the clinical and radiographic improvements of each biologic compared to baseline and in comparison with each other.

Conditions

• Degenerative Conditions of the Lumbar Spine

Interventions

Type	Name	Description
BIOLOGICAL	AttraX Putty
OTHER	Iliac Crest Bone Graft (ICBG)

Timeline

• Start date: 2014-12-01
• Primary completion: 2021-05-21
• Completion: 2021-05-21
• First posted: 2014-09-26
• Last updated: 2025-12-22

Locations

1 site across 1 country: Brazil