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

Zenoss

Status: Completed

Conditions: Fusion of Spine (Disease); Stenosis

Treatments: Procedure: transforaminal lumbar interbody arthrodesis

Study type: Interventional

Funder types: Other

Identifiers

NCT02485574

KSong

Details and patient eligibility

About

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.

Full 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.

Enrollment: 69 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients who need lumbar interbody fusion in Degenerative spine disease on L1-S1(Spinal stenosis, HIVD and internal derangement of disk, spine instability)
• Patients who have no communication problems
• Patients who are willing to visit the hospital for any follow-up assessment
• Patients who voluntarily sign on a written consent

Exclusion criteria

• Patients who have infection
• Patients who have bleeding disorders
• Patients who have immunosuppressed disease
• Patients who can't sign on consent form
• Patients who are in pregnancy or breast feeding
• Patients who have severe osteoporosis
• Patients who can't take general surgery because of severe liver disease or decreased renal function
• Patients who have acute spinal injury, spinal tumor or inflammatory spinal disease

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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69 participants in 2 patient groups

Left cage- auto bone

Experimental group

Description:

At the operated segment, left cage was filled with auto bone only. We evaluated bone bridging between inside and outside the cage in transforaminal lumbar interbody arthrodesis.

Treatment:

Procedure: transforaminal lumbar interbody arthrodesis

Right cage- auto local bone mixed with β-calcium phosphate + hydroxyapatite

Experimental group

Description:

At the operated segment, right cage was filled with auto local bone mixed with β-calcium phosphate + hydroxyapatite. We evaluated bone bridging between inside and outside the cage in transforaminal lumbar interbody arthrodesis.

Treatment:

Procedure: transforaminal lumbar interbody arthrodesis