Comparison of Standalone Anterior Lumbar Interbody Fusion (ALIF) L5/S1 Performed With Either rhBMP-2 or ViviGen®

Study Overview
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Brief Summary
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The aim of this study is to prospectively investigate the potential for bony fusion of ViviGen® bone graft substitute in comparison to rhBMP-2 in standalone ALIF procedure L5/S1

Detailed Description
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The investigator hypothesize that the intervention group administered ViviGen® would, following surgery, experience: Comparable bony fusion rates, evaluated via CT scan one year postoperatively Comparable clinical outcome/ simplified COMI-score one year postoperatively Comparable/ less inpatient length of stay (LOS) Comparable/ less healthcare costs one year postoperatively For patients included in the study, all follow-up is recorded, with regards to radiological and clinical outcome. Follow up will be evaluated after 14 days, 6 weeks, 6 and 12 months. Last follow up will be 1 year after surgery.

Official Title
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Comparison of Radiographic Fusion Rate & Clinical Outcome of Standalone ALIF L5/S1 Performed With Either rhBMP-2 or ViviGen® Cellular Bone Matrix, a Prospective Randomized Assessor Blind, Monocentric Trial

Conditions
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Spondylosis, Spondylolisthesis, Degenerative Disc Disease

Intervention / Treatment
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* Other: ViviGen®
* Other: rhBMP-2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients that present the indication for performing ALIF procedure L5/S1 (incl. stabilizations), e.g.,treating conditions such as spondylosis, spondylolisthesis and degenerative disc disorders with back and/or leg pain Patients must be 18 -70 years of age Patients must have understood and signed the study information and the informed consent form Patients are willing and able to complete scheduled follow-up evaluations / questionnaires as described in the Informed Consent Exclusion Criteria: Patients under 18 years and over 70 of age Patients with tumor/ spine trauma/ known bone disease / parkinsons disease and similar central nervous system (CNS) disorders / diseases or injuries of the peripheral nerves Other procedures than ALIF and other lumbar segments than L5/S1 Current Smoking Pregnant or breastfeeding patients inadequate language skills in German Inability to give informed consent Refusal to participate in the study, unsigned study consent Participation in another interventional study within the 30 days preceding and during the present study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a prospective randomized assessor blind monocentric trial. It aims for non-inferiority.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group 5-5.4 cc ViviGen®<br>Biological: 5-5.4 cc ViviGen®The stand-alone ALIF L5/S1 fusion patients assigned to this group will receive 5-5.4 cc ViviGen® | Other: ViviGen®<br>* It will investigate the radiological and clinical outcome of stand-alone ALIF procedure L5/S1 using two arms/ treatments, namely either ViviGen® Bone Matrix (intervention group) or rhBMP-2 (control group). ViviGen®/ rhBMP-2 ratio will be 1:1.<br>|
| Active Comparator: Control group 4-6mg rhBMP-2<br>Biological: 4-6mg rhBMP-2The stand-alone ALIF L5/S1 fusion patients assigned to this group will receive 4-6mg rhBMP-2 | Other: rhBMP-2<br>* It will investigate the radiological and clinical outcome of stand-alone ALIF procedure L5/S1 using two arms/ treatments, namely either ViviGen® Bone Matrix (intervention group) or rhBMP-2 (control group). ViviGen®/ rhBMP-2 ratio will be 1:1.<br>* Other names: InductOS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of interbody bony fusion in the lumbar segment L5/S1 using Brantigan, Steffee, Fraser (BSF) | The rate of interbody bony fusion will be assessed by computed tomography and then by a radiologist 12 months after the intervention. Modified Brantigan, Steffee, Fraser (BSF) classification of interbody fusion success will be defined as follows: BSF-1: Radiographical pseudarthrosis is indicated by collapse of the construct, loss of disc height, vertebral slip, broken screws, displacement of the Synfix cage, or significant resorption of the bone graft, or lucency visible around the periphery of the graft or cage. BSF-2: Radiographical locked pseudarthrosis is indicated by lucency visible in the middle of the cages with solid bone growing into the cage from each vertebral endplate. BSF-3: Radiographical fusion: bone bridges at least half of the fusion area with at least the density originally achieved at surgery. Radiographical fusion through one cage (half of the fusion area) is considered to be mechanically solid fusion even if there is lucency on the opposite side. | 12 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Back pain visual analogue scale | The back pain visual analogue scale (VAS 1-10) will be assessed before intervention and at 6 weeks, 6 months and 12 months after intervention. | before intervention and at 6 weeks, 6 months and 12 months after intervention | 
| Leg pain visual analogue scale | The leg pain visual analogue scale (VAS 1-10) will be assessed before intervention and at 6 weeks, 6 months and 12 months after intervention. | before intervention and at 6 weeks, 6 months and 12 months after intervention | 
| Quality of life using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score) | Quality of life will be assessed by using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score) before intervention and at 6 weeks, 6 months and 12 months after intervention. | before intervention and at 6 weeks, 6 months and 12 months after intervention | 
| Disability/ limitations in the activities of daily living using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score) | Disability / limitations in the activities of daily living will be assessed by using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score) before intervention and at 6 weeks, 6 months and 12 months after intervention. | before intervention and at 6 weeks, 6 months and 12 months after intervention | 
| Disability/ limitations at the workplace using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score) | Disability / limitations at the workplace will be assessed by using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score) before intervention and at 6 weeks, 6 months and 12 months after intervention. | before intervention and at 6 weeks, 6 months and 12 months after intervention | 
| Patient satisfaction using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score) | Patient satisfaction will be assessed by using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score) at 6 weeks, 6 months and 12 months after intervention. | 6 weeks, 6 months and 12 months after intervention | 
| Complication / side effects using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score) | Complication / side effects will be assessed by using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score) at 14 days, 6 weeks, 6 months and 12 months after intervention. | 14 days, 6 weeks, 6 months and 12 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recombinant human bone morphogenetic protein-2, Spondylosis, Degenerative Disc Disease, Spondylolisthesis, ViviGen, Radiographic fusion rate, Anterior lumbar interbody fusion