About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- ViviGen®
- rhBMP-2