Comparison of Radiographic Fusion Rate and Clinical Outcome of ALIF and XLIF Performed With Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen®
Recruiting now · Not applicable
Conditions studied: Spondylosis, Spondylolisthesis, Degenerative Disc Disease
In brief
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
Key facts
- Study ID
- NCT05238740
- Run by
- Lindenhofgruppe AG
- People needed
- 168
- Starts
- 2022-10-27
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2025-06-08
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 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
You may not qualify 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 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
Where it is running
- Orthopädie Sonnenhof — Bern, Switzerland (enrolling)
Full record on ClinicalTrials.gov
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