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Recruiting NCT05238740

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

No phase Interventional Spondylosis Spondylolisthesis Degenerative Disc Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ViviGen®, rhBMP-2.
Who it may be relevant to
Registry conditions: Spondylosis, Spondylolisthesis, Degenerative Disc Disease. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Other ViviGen®
    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 rhBMP-2
    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.

Primary outcome measures

  • 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]
Secondary outcome measures (7)
  • Back pain visual analogue scale [Time frame: before intervention and at 6 weeks, 6 months and 12 months after intervention]
  • Leg pain visual analogue scale [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 14 days, 6 weeks, 6 months and 12 months after intervention]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Switzerland · 1 center
  • Orthopädie Sonnenhof — Bern

Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT05238740 · 2021-02219

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗