Comparison of Radiographic Fusion Rate and Clinical Outcome of ALIF and XLIF Performed With Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen®
Comparison of Radiographic Fusion Rate and Clinical Outcome of Anterior Lumbar and Extreme Lateral Interbody Fusion Performed With Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen® Cellular Bone Matrix, a Prospective Randomised Assessor Blind, Monocentric Trial
Lindenhofgruppe AG
168 participants
Oct 27, 2022
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Inclusion Criteria4
- Patients who have an indication for a monosegmental ALIF procedure on the L5/S1 segment or a monosegmental XLIF procedure on L4/5 (both ALIF and XLIF procedure with or without an additional pedicular stabilisation), 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 Criteria9
- 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
- Pregnant or breastfeeding patients (or patient planning a pregnancy within one year after surgery)
- Insufficient 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
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Interventions
It 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.
It 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.
Locations(1)
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NCT05238740