Comparing two bone grafts for spine surgery outcomes

Comparison of Radiographic Fusion Rate and Clinical Outcome of Anterior Lumbar and Extreme Lateral Interbody Fusion Performed With Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen® Cellular Bone Matrix, a Prospective Randomised Assessor Blind, Monocentric Trial

This study is testing whether two different bone grafts can help patients with spine surgery heal better and achieve solid bone fusion.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 168 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Lindenhofgruppe AG (industry)
• Locations: 1 site (Bern)
• Trial ID: NCT05238740 on ClinicalTrials.gov

What this trial studies

This study aims to compare the effectiveness of two different bone graft substitutes, ViviGen® and recombinant human bone morphogenetic protein-2 (rhBMP-2), in achieving bony fusion during anterior lumbar interbody fusion (ALIF) and extreme lateral interbody fusion (XLIF) procedures. It will prospectively evaluate the radiographic fusion rates and clinical outcomes in patients undergoing these surgeries for conditions like spondylosis and degenerative disc disease. Follow-up assessments will be conducted at multiple intervals up to one year post-surgery to monitor fusion rates and patient recovery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with indications for monosegmental ALIF or XLIF procedures due to spondylosis, spondylolisthesis, or degenerative disc disease.

Not a fit: Patients with spinal tumors, trauma, known bone diseases, or those outside the age range of 18 to 70 may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into more effective bone graft options for spinal fusion surgeries, potentially improving patient outcomes.

How similar studies have performed: Previous studies have shown varying success with similar bone graft substitutes, but this specific comparison is novel.

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

Where this trial is running

Bern

• Orthopädie Sonnenhof — Bern, Switzerland (RECRUITING)

Study contacts

• Principal investigator: Diel Peter, Dr. med. — Orthopädie Sonnenhof, Bern
• Study coordinator: Diel Peter, Dr. med

Conditions: Spondylosis, Spondylolisthesis, Degenerative Disc Disease, ViviGen, Radiographic fusion rate, Anterior lumbar interbody fusion, Recombinant human bone morphogenetic protein-2, Extreme lateral interbody fusion