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

Launched by LINDENHOFGRUPPE AG · Feb 3, 2022

Keywords

ClinConnect Summary

This clinical trial is looking to compare two different methods of promoting bone healing in a specific back surgery called Anterior Lumbar Interbody Fusion (ALIF) at the L5/S1 level. The two methods being studied are a bone graft substitute called ViviGen® and a substance known as rhBMP-2. Both approaches aim to help patients with conditions like spondylosis, spondylolisthesis, and degenerative disc disease, which can cause back and leg pain.

To participate in this study, candidates should be between 18 and 70 years old and need to be planning to undergo the ALIF procedure for their back issues. They must also be able to understand the study information and sign a consent form. If selected, participants will undergo the surgery and participate in follow-up evaluations to help researchers learn which method works better for bone healing. It's important to note that certain individuals, such as those with specific health conditions, smokers, and pregnant or breastfeeding women, won't be eligible for this trial.

Gender

ALL

Eligibility criteria

• 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