Overview
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 standalone ALIF procedure L5/S1
Description
The investigator hypothesize that the intervention group administered ViviGen® would, following surgery, experience:
- Comparable bony fusion rates, evaluated via CT scan one year postoperatively
- Comparable clinical outcome/ simplified COMI-score one year postoperatively
- Comparable/ less inpatient length of stay (LOS)
- Comparable/ less healthcare costs one year postoperatively
For patients included in the study, all follow-up is recorded, with regards to radiological and clinical outcome. Follow up will be evaluated after 14 days, 6 weeks, 6 and 12 months. Last follow up will be 1 year after surgery.
Eligibility
Inclusion Criteria:
Patients that present the indication for performing ALIF procedure L5/S1 (incl.
stabilizations), 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 of age
- Patients with tumor/ spine trauma/ known bone disease / parkinsons disease and similar
central nervous system (CNS) disorders / diseases or injuries of the peripheral nerves
- Other procedures than ALIF and other lumbar segments than L5/S1
- Current Smoking
- Pregnant or breastfeeding patients
- inadequate 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