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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stenosis, Fusion of Spine (Disease)

Intervention / Treatment
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* Procedure: transforaminal lumbar interbody arthrodesis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Left cage- auto bone<br>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. | Procedure: transforaminal lumbar interbody arthrodesis<br>* 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.<br>* Other names: Auto-local bone;|
| Experimental: Right cage- auto local bone mixed with β-calcium phosphate + hydroxyapatite<br>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. | Procedure: transforaminal lumbar interbody arthrodesis<br>* 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.<br>* Other names: Auto-local bone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| InCBB of Both Cages | We used the concept of InCBB (intra-cage bridging bone) to evaluate the fusion status. InCBB was defined as the bridging bone between the upper and lower vertebrae through the void of the cage(s) and divided into right (Rt.) and left (Lt.) InCBB according to the cage position. We graded bridging scores from 0 to 2 based on the degree of completion of the bridging bone in InCBBs (grade 0: no bridging at the superior and inferior endplates; grade 1: incomplete bridging; bridging at the superior or inferior endplate, but with a clear radiolucent line; grade 2: complete bridging). | 12 month postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ABB (Anterior Bone Bridging) Between Cage and Anterior Grafted Bone | We defined ABB as the bridging bone between the extra-cage grafted bone and intra-cage grafted bone through the holes in each cage. Since the cages used in this study each have 4 anterior holes, there can be a minimum of 0 and a maximum of 8 ABBs in a patient. | 12 month postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone bridging, Arthrodesis, Lumbar, Cage