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

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05238740
• Other study ID #: 2021-02219
• Status: Recruiting
• Phase: N/A
• Start date: October 27, 2022
• Est. completion date: November 2026

Study information

• Verified date: January 2024
• Source: Lindenhofgruppe AG
• Contact: Diel Peter, Dr. med
• Phone: +41 31 358 17 90
• Email: peter.diel[@]sonnenhof.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 standalone ALIF procedure L5/S1

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Spondylolisthesis
• Spondylosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	Orthopädie Sonnenhof	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Lindenhofgruppe AG

Country where clinical trial is conducted

Switzerland, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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