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

RecruitingNAAges 18 Years - 70 YearsAllLindenhofgruppe AG
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion criteria: 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 criteria: * 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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What it tests

  • ViviGen®
  • rhBMP-2
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Where

1 site
Orthopädie Sonnenhof
Bern, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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