Status:
RECRUITING
Comparison of Radiographic Fusion Rate and Clinical Outcome of ALIF and XLIF Performed With Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen®
Lead Sponsor:
Lindenhofgruppe AG
Conditions:
Spondylosis
Spondylolisthesis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 monosegmenta...
Detailed Description
The investigator hypothesize that \- The bony fusion rate on a 12-month CT scan (or earlier at 6-month CT scan) is less than 10% lower in the intervention group compared to the bony fusion rate in th...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT05238740
Start Date
October 27 2022
End Date
December 1 2027
Last Update
June 8 2025
Active Locations (1)
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1
Orthopädie Sonnenhof
Bern, Switzerland, 3006