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Clinical Trials in Switzerland / NCT05238740
Recruiting Not applicable

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

NCT05238740 · tracked via the Priya Life Science Switzerland tracker
Sponsor
Lindenhofgruppe AG
Phase
Not applicable
Started
2022-10-27
Last updated
2026-08-26

Condition(s) studied

SpondylosisSpondylolisthesisDegenerative Disc Disease

Investigational drug(s) / intervention(s)

ViviGen®rhBMP-2

ViviGen®: It will investigate the radiological and clinical outcome of ALIF procedure L5/S1 and XLIF L4/L5 procedure using two arms/ treatments, namely either ViviGen® Bone Matrix (intervention group) or rhBMP-2 (control group). ViviGen®/ rhBMP-2 ratio will be 1:1.

rhBMP-2: It will investigate the radiological and clinical outcome of ALIF procedure L5/S1 and XLIF L4/L5 procedure using two arms/ treatments, namely either ViviGen® Bone Matrix (intervention group) or rhBMP-2 (control group). ViviGen®/ rhBMP-2 ratio will be 1:1.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Rate of interbody bony fusion in the treated patients confirmed at 12-month CT or earlier at 6-month CT using Brantigan, Steffee, Fraser (BSF) — 6 or 12 months after intervention
    The rate of interbody bony fusion will be assessed by computed tomography and then by a radiologist 6 or 12 months after the intervention. Modified Brantigan, Steffee, Fraser (BSF) classification of interbody fusion success will be defined as follows: BSF-1: Radiographical pseudarthrosis is indicated by collapse of the construct, loss of disc height, vertebral slip, broken screws, displacement of the Synfix cage, or significant resorption of the bone graft, or lucency visible around the periphery of the graft or cage. BSF-2: Radiographical locked pseudarthrosis is indicated by lucency visible in the middle of the cages with solid bone growing into the cage from each vertebral endplate. BSF-3: Radiographical fusion: bone bridges at least half of the fusion area with at least the density originally achieved at surgery. Radiographical fusion through one cage (half of the fusion area) is considered to be mechanically solid fusion even if there is lucency on the opposite side.

Trial sites (1)

FacilityCityRegionStatus
Orthopädie Sonnenhof Bern Switzerland Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05238740 on ClinicalTrials.gov ↗ ← All trials in Switzerland