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

NCT05238740 | Recruiting

• 1 other identifier: 2021-02219
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Spondylosis; Spondylolisthesis; Degenerative Disc Disease

Keywords

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

Outcome Measures

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)

  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.

  6 or 12 months after intervention

Secondary Outcomes (7)

• Back pain visual analogue scale

  before intervention and at 6 weeks, 6 months and 12 months after intervention

• Leg pain visual analogue scale

  before intervention and at 6 weeks, 6 months and 12 months after intervention

• Quality of life 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

• Disability/ limitations in the activities of daily living 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

• Disability/ limitations at the workplace 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

Other Outcomes (1)

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

  12 months after intervention

Study Arms (2)

Intervention group 5-5.4 cc ViviGen®

ACTIVE COMPARATOR

Biological: 5-5.4 cc ViviGen® The ALIF or XLIF fusion patients assigned to this group will receive 5-5.4 cc ViviGen®

Other: ViviGen®

Control group 4-6mg rhBMP-2

ACTIVE COMPARATOR

Biological: 4-6mg rhBMP-2 The ALIF or XLIF fusion patients assigned to this group will receive 4-6mg rhBMP-2

Other: rhBMP-2

Interventions

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.

Intervention group 5-5.4 cc ViviGen®

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.

Also known as: InductOS

Control group 4-6mg rhBMP-2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Lindenhofgruppe AG: lead

Study Sites (1)

Orthopädie Sonnenhof

Bern, 3006, Switzerland

RECRUITING

Related Publications (7)

• Arrington ED, Smith WJ, Chambers HG, Bucknell AL, Davino NA. Complications of iliac crest bone graft harvesting. Clin Orthop Relat Res. 1996 Aug;(329):300-9. doi: 10.1097/00003086-199608000-00037.

  PMID: 8769465 BACKGROUND

• Birmingham E, Niebur GL, McHugh PE, Shaw G, Barry FP, McNamara LM. Osteogenic differentiation of mesenchymal stem cells is regulated by osteocyte and osteoblast cells in a simplified bone niche. Eur Cell Mater. 2012 Jan 12;23:13-27. doi: 10.22203/ecm.v023a02.

  PMID: 22241610 BACKGROUND

• Johnstone B, Zhang N, Waldorff EI, Semler E, Dasgupta A, Betsch M, Punsalan P, Cho H, Ryaby JT, Yoo J. A Comparative Evaluation of Commercially Available Cell-Based Allografts in a Rat Spinal Fusion Model. Int J Spine Surg. 2020 Apr 30;14(2):213-221. doi: 10.14444/7026. eCollection 2020 Apr.

  PMID: 32355628 BACKGROUND

• Kadam A, Millhouse PW, Kepler CK, Radcliff KE, Fehlings MG, Janssen ME, Sasso RC, Benedict JJ, Vaccaro AR. Bone substitutes and expanders in Spine Surgery: A review of their fusion efficacies. Int J Spine Surg. 2016 Sep 22;10:33. doi: 10.14444/3033. eCollection 2016.

  PMID: 27909654 BACKGROUND

• Manzur M, Virk SS, Jivanelli B, Vaishnav AS, McAnany SJ, Albert TJ, Iyer S, Gang CH, Qureshi S. The rate of fusion for stand-alone anterior lumbar interbody fusion: a systematic review. Spine J. 2019 Jul;19(7):1294-1301. doi: 10.1016/j.spinee.2019.03.001. Epub 2019 Mar 11.

  PMID: 30872148 BACKGROUND

• Singh K, Ahmadinia K, Park DK, Nandyala SV, Marquez-Lara A, Patel AA, Fineberg SJ. Complications of spinal fusion with utilization of bone morphogenetic protein: a systematic review of the literature. Spine (Phila Pa 1976). 2014 Jan 1;39(1):91-101. doi: 10.1097/BRS.0000000000000004.

  PMID: 24026158 BACKGROUND

• Wetzell B, McLean JB, Moore MA, Kondragunta V, Dorsch K. A large database study of hospitalization charges and follow-up re-admissions in US lumbar fusion surgeries using a cellular bone allograft (CBA) versus recombinant human bone morphogenetic protein-2 (rhBMP-2). J Orthop Surg Res. 2020 Nov 19;15(1):544. doi: 10.1186/s13018-020-02078-7.

  PMID: 33213484 BACKGROUND

MeSH Terms

Conditions

Spondylosis; Spondylolisthesis; Intervertebral Disc Degeneration

Interventions

Bone Morphogenetic Protein 2

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis

Intervention Hierarchy (Ancestors)

Bone Morphogenetic Proteins; TGF-beta Superfamily Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Diel Peter, Dr. med.

  Orthopädie Sonnenhof, Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diel Peter, Dr. med

CONTACT

+41 31 358 17 90; peter.diel@sonnenhof.ch

Sabine Berger

CONTACT

+41 79 328 50 24; sabine.berger@lindenhofgruppe.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The CT Reviewer and data analysts, will be blinded as to which bone graft treatment the patient received. Blinding is ensured by coding the electronic case report forms (eCRFs)/ database and images.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a prospective randomized assessor blind monocentric trial. It aims for non-inferiority.

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: February 14, 2022
• Study Start: October 27, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)