NCT02485574

Anterior Bridging Cage With Bone Substitute Versus Localized Autobone in Transforaminal Lumbar Interbody Arthrodesis

Prospective, Observational Study of Anterior Bridging Cage Augmented With Bone Substitute Versus Localized Autobone in Transforaminal Lumbar Interbody Arthrodesis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Zenoss Co, Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluation for the pattern of bone bridging of patients who undergo transforaminal lumbar interbody arthrodesis, the investigators hypothesize that auto local bone mixed with β-calcium phosphate + hydroxyapatite (OSTEON 2, Genoss) is not inferior to auto local bone only. In addition, the investigators will analyze anterior new bone bridging pattern between anterior bridging cage newly developed and grafted bone in anterior disc space.

Detailed description

A single center, observational, single arm study to evaluate the efficacy of auto local bone mixed with β-calcium phosphate + hydroxyapatite using interbody fusion assessment on multi-axial CT scan. Its active comparator is auto local bone. Anterior bridging bone between anterior grafted bone and inserted cage will be assessed by using newly developed anterior bridging cage as well as interbody bone bridging between two vertebral bodies on multi-axial reconstructed CT scan. The patients undergoes arthrodesis surgery will have two cages, one augmented with auto local bone will be located at left side of disc space and the other cage augmented with auto local bone mixed with β-calcium phosphate + hydroxyapatite at right side of disc space.

Conditions

• Stenosis
• Fusion of Spine (Disease)

Interventions

Type	Name	Description
PROCEDURE	transforaminal lumbar interbody arthrodesis	Anterior bridging cages augmented with auto bone plus β-calcium phosphate + hydroxyapatite in right side of disc space and anterior bridging cages augmented with auto bone in left side of disc space in transforaminal lumbar interbody arthrodesis.

Timeline

• Start date: 2015-03-01
• Primary completion: 2019-04-01
• Completion: 2019-06-01
• First posted: 2015-06-30
• Last updated: 2021-12-08
• Results posted: 2021-11-09

Locations

1 site across 1 country: South Korea