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Official title Comparison of Radiographic Fusion Rate and Clinical Outcome of ALIF and XLIF Performed With Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen®
ClinicalTrials.gov ID: NCT05238740
What this study is testing
- What it's testing
- 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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)...
- 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
- 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 treatment study within the 30 days preceding and during the present study
The study team makes the final eligibility decision.
Where it's taking place
- Bern, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bern, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.