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NCT Number: NCT05238740

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

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

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Key information

Conditions

Spondylosis Bone Diseases Degenerative Disc Disease Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases Spondylolisthesis Spondylolysis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The investigator hypothesize that

  • The bony fusion rate on a 12-month CT scan (or earlier at 6-month CT scan) is less than 10% lower in the intervention group compared to the bony fusion rate in the control group

For patients included in the study, all follow-up is recorded, with regards to radiological and clinical outcome. Follow up will be evaluated after 14 days, 6 weeks, 6 and 12 months. Last follow up will be 1 year after surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ViviGen®

Other

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

Other

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.

Other names: InductOS

Primary outcomes

  1. 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)

    Time frame: 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.

Secondary outcomes

  1. Back pain visual analogue scale

    Time frame: before intervention and at 6 weeks, 6 months and 12 months after intervention

    The back pain visual analogue scale (VAS 1-10) will be assessed before intervention and at 6 weeks, 6 months and 12 months after intervention.

  2. Leg pain visual analogue scale

    Time frame: before intervention and at 6 weeks, 6 months and 12 months after intervention

    The leg pain visual analogue scale (VAS 1-10) will be assessed before intervention and at 6 weeks, 6 months and 12 months after intervention.

  3. Quality of life using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score)

    Time frame: before intervention and at 6 weeks, 6 months and 12 months after intervention

    Quality of life will be assessed by using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score) before intervention and at 6 weeks, 6 months and 12 months after intervention.

  4. Disability/ limitations in the activities of daily living using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score)

    Time frame: before intervention and at 6 weeks, 6 months and 12 months after intervention

    Disability / limitations in the activities of daily living will be assessed by using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score) before intervention and at 6 weeks, 6 months and 12 months after intervention.

  5. Disability/ limitations at the workplace using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score)

    Time frame: before intervention and at 6 weeks, 6 months and 12 months after intervention

    Disability / limitations at the workplace will be assessed by using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score) before intervention and at 6 weeks, 6 months and 12 months after intervention.

  6. Patient satisfaction using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score)

    Time frame: 6 weeks, 6 months and 12 months after intervention

    Patient satisfaction will be assessed by using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score) at 6 weeks, 6 months and 12 months after intervention.

  7. Complication / side effects using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score)

    Time frame: 14 days, 6 weeks, 6 months and 12 months after intervention

    Complication / side effects will be assessed by using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score) at 14 days, 6 weeks, 6 months and 12 months after intervention.

Other outcomes

  1. Healthcare-costs using hospitalisation length of stay (LOS), occurrence and therapy of side effects/ adverse events and necessary revision operations

    Time frame: 12 months after intervention

    Healthcare-costs will be assessed by using hospitalisation length of stay (LOS), occurrence and therapy of side effects/ adverse events and necessary revision operations at 12 months after intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Diel Peter, Dr. med

CONTACT

[email protected]

+41 31 358 17 90

Sabine Berger

CONTACT

[email protected]

+41 79 328 50 24

Sponsors and collaborators

Lead sponsor

Lindenhofgruppe AG

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 14, 2022
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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