Clinical trial NCT05238740: Comparison of Radiographic Fusion Rate and Clinical Outcome of ALIF and XLIF Performed With Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen®
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Lindenhofgruppe AG
Sponsor class: INDUSTRY
First posted: 2022-02-14
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a prospective randomized assessor blind monocentric trial. It aims for non-inferiority.
Primary purpose: OTHER

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

Detailed description: 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.

Eligibility criteria: 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 outcomes:
measure: 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)
timeFrame: 6 or 12 months after intervention
Secondary outcomes:
measure: Back pain visual analogue scale
timeFrame: before intervention and at 6 weeks, 6 months and 12 months after intervention
measure: Leg pain visual analogue scale
timeFrame: before intervention and at 6 weeks, 6 months and 12 months after intervention
measure: Quality of life using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score)
timeFrame: before intervention and at 6 weeks, 6 months and 12 months after intervention
measure: Disability/ limitations in the activities of daily living using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score)
timeFrame: before intervention and at 6 weeks, 6 months and 12 months after intervention
measure: Disability/ limitations at the workplace using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score)
timeFrame: before intervention and at 6 weeks, 6 months and 12 months after intervention
measure: Patient satisfaction using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score)
timeFrame: 6 weeks, 6 months and 12 months after intervention
measure: Complication / side effects using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score)
timeFrame: 14 days, 6 weeks, 6 months and 12 months after intervention
Other outcomes:
measure: Healthcare-costs using hospitalisation length of stay (LOS), occurrence and therapy of side effects/ adverse events and necessary revision operations
timeFrame: 12 months after intervention
Locations:
city: Bern
country: Switzerland
facility: Orthopädie Sonnenhof
Study officials:
affiliation: Orthopädie Sonnenhof, Bern
name: Diel Peter, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.
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.
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.