Comparison of Standalone Anterior Lumbar Interbody Fusion (ALIF) L5/S1 Performed With Either rhBMP-2 or ViviGen®

Comparison of Radiographic Fusion Rate & Clinical Outcome of Standalone ALIF L5/S1 Performed With Either rhBMP-2 or ViviGen® Cellular Bone Matrix, a Prospective Randomized Assessor Blind, Monocentric Trial

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 standalone ALIF procedure L5/S1

Study Overview

• Status: Recruiting
• Conditions: Degenerative Disc Disease; Spondylosis; Spondylolisthesis
• Intervention / Treatment: Other: ViviGen®; Other: rhBMP-2

Detailed Description

The investigator hypothesize that the intervention group administered ViviGen® would, following surgery, experience:

• Comparable bony fusion rates, evaluated via CT scan one year postoperatively
• Comparable clinical outcome/ simplified COMI-score one year postoperatively
• Comparable/ less inpatient length of stay (LOS)
• Comparable/ less healthcare costs one year postoperatively

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.

• Study Type: Interventional
• Enrollment (Estimated): 168
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diel Peter, Dr. med; Phone Number: +41 31 358 17 90; Email: peter.diel@sonnenhof.ch
• Study Contact Backup: Name: Sabine Berger; Phone Number: +41 79 328 50 24; Email: sabine.berger@lindenhofgruppe.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3006
    • Recruiting
    • Orthopädie Sonnenhof
    • Contact: Peter Diel, Dr.med.; Phone Number: +41 31 358 17 90; Email: peter.diel@sonnenhof.ch
    • Contact: Sabine Berger; Phone Number: +41793285024; Email: sabine.berger@lindenhofgruppe.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Patients that present the indication for performing ALIF procedure L5/S1 (incl. stabilizations), 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 of age
• Patients with tumor/ spine trauma/ known bone disease / parkinsons disease and similar central nervous system (CNS) disorders / diseases or injuries of the peripheral nerves
• Other procedures than ALIF and other lumbar segments than L5/S1
• Current Smoking
• Pregnant or breastfeeding patients
• inadequate 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention group 5-5.4 cc ViviGen®; Biological: 5-5.4 cc ViviGen®The stand-alone ALIF L5/S1 fusion patients assigned to this group will receive 5-5.4 cc ViviGen®	Other: ViviGen®; It will investigate the radiological and clinical outcome of stand-alone ALIF procedure L5/S1 using two arms/ treatments, namely either ViviGen® Bone Matrix (intervention group) or rhBMP-2 (control group). ViviGen®/ rhBMP-2 ratio will be 1:1.
Active Comparator: Control group 4-6mg rhBMP-2; Biological: 4-6mg rhBMP-2The stand-alone ALIF L5/S1 fusion patients assigned to this group will receive 4-6mg rhBMP-2	Other: rhBMP-2; It will investigate the radiological and clinical outcome of stand-alone ALIF procedure L5/S1 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of interbody bony fusion in the lumbar segment L5/S1 using Brantigan, Steffee, Fraser (BSF)	The rate of interbody bony fusion will be assessed by computed tomography and then by a radiologist 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.	12 months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Back pain visual analogue scale	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.	before intervention and at 6 weeks, 6 months and 12 months after intervention
Leg pain visual analogue scale	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.	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)	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.	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)	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.	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)	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.	before intervention and at 6 weeks, 6 months and 12 months after intervention
Patient satisfaction using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score)	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.	6 weeks, 6 months and 12 months after intervention
Complication / side effects using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score)	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.	14 days, 6 weeks, 6 months and 12 months after intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare-costs using hospitalisation length of stay (LOS), occurrence and therapy of side effects/ adverse events and necessary revision operations	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.	12 months after intervention

Collaborators and Investigators

• Sponsor: Lindenhofgruppe AG
• Investigators: Principal Investigator: Diel Peter, Dr. med., Orthopädie Sonnenhof, Bern

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: January 7, 2022
• First Submitted That Met QC Criteria: February 3, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Degenerative Disc Disease; Spondylolisthesis; Spondylosis; ViviGen; Radiographic fusion rate; Anterior lumbar interbody fusion; Recombinant human bone morphogenetic protein-2
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Intervertebral Disc Degeneration; Spondylosis; Spondylolisthesis
• Other Study ID Numbers: 2021-02219

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No