Comparison of Radiographic Fusion Rate and Clinical Outcome of ALIF and XLIF Performed With Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen®

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorLindenhofgruppe AG

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

Treatment groups

168 Participants
are divided into 2 treatment groups

Sponsors and collaborators