Comparing two bone grafts for spine surgery outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Orthopädie Sonnenhof
  Bern, Switzerland Recruiting

Study contacts

• Principal investigator: Diel Peter, Dr. med. — Orthopädie Sonnenhof, Bern
• Study coordinator: Diel Peter, Dr. med
• Email: peter.diel@sonnenhof.ch
• Phone: +41 31 358 17 90

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.