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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• 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) [Срок оценки: 6 or 12 months after intervention]

Вторичные конечные точки (7)

• Back pain visual analogue scale [Срок оценки: before intervention and at 6 weeks, 6 months and 12 months after intervention]
• Leg pain visual analogue scale [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 14 days, 6 weeks, 6 months and 12 months after intervention]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Швейцария · 1 центр

• Orthopädie Sonnenhof — Bern

Публикации

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• 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

Идентификаторы

NCT: NCT05238740 · 2021-02219

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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