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 monosegmental ALIF procedure L5/S1 and in monosegmental XLIF procedure L4/5
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
Patients under 18 years and over 70 years of age
Patients with tumour / spine trauma / known bone disease / Parkinson's disease and similar CNS disorders / diseases or injuries of the peripheral nerves
Other procedures or segment than mentioned in the inclusion citeriaAdditional planed spine surgeries after index surgery
Current smoking
Parallel
ViviGen®
Other interventionIt will investigate the radiological and clinical outcome of ALIF procedure L5/S1 and XLIF L4/L5 procedure using two arms/ treatments, namely either ViviGen® Bone Matrix (intervention group) or rhBMP-2 (control group). ViviGen®/ rhBMP-2 ratio will be 1:1.
rhBMP-2
Other interventionIt will investigate the radiological and clinical outcome of ALIF procedure L5/S1 and XLIF L4/L5 procedure using two arms/ treatments, namely either ViviGen® Bone Matrix (intervention group) or rhBMP-2 (control group). ViviGen®/ rhBMP-2 ratio will be 1:1.
Rate of interbody bony fusion in the treated patients confirmed at 12-month CT or earlier at 6-month CT using Brantigan, Steffee, Fraser (BSF)
The rate of interbody bony fusion will be assessed by computed tomography and then by a radiologist 6 or 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.
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.
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.
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.
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.
Healthcare-costs using hospitalisation length of stay (LOS), occurrence and therapy of side effects/ adverse events and necessary revision operations
Healthcare-costs will be assessed by using hospitalisation length of stay (LOS), occurrence and therapy of side effects/ adverse events and necessary revision operations at 12 months after intervention.
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