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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group 5-5.4 cc ViviGen® | Active Comparator | Biological: 5-5.4 cc ViviGen® The ALIF or XLIF fusion patients assigned to this group will receive 5-5.4 cc ViviGen® |
|
| Control group 4-6mg rhBMP-2 | Active Comparator | Biological: 4-6mg rhBMP-2 The ALIF or XLIF fusion patients assigned to this group will receive 4-6mg rhBMP-2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ViviGen® | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | The rate of interbody bony fusion will be assessed by computed tomography and then by a radiologist 6 or 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. | 6 or 12 months after intervention |
| 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 |
| 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 |
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
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diel Peter, Dr. med | Contact | +41 31 358 17 90 | peter.diel@sonnenhof.ch | |
| Sabine Berger | Contact | +41 79 328 50 24 | sabine.berger@lindenhofgruppe.ch |
| Name | Affiliation | Role |
|---|---|---|
| Diel Peter, Dr. med. | Orthopädie Sonnenhof, Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopädie Sonnenhof | Recruiting | Bern | 3006 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8769465 | Background | 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. | |
| 22241610 | Background | 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. |
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The study is a prospective randomized assessor blind monocentric trial. It aims for non-inferiority.
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The CT Reviewer and data analysts, will be blinded as to which bone graft treatment the patient received. Blinding is ensured by coding the electronic case report forms (eCRFs)/ database and images.
| rhBMP-2 | Other | 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. |
|
|
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 |
| 32355628 | Background | 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. |
| 27909654 | Background | 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. |
| 30872148 | Background | 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. |
| 24026158 | Background | 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. |
| 33213484 | Background | 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. |
| ID | Term |
|---|---|
| D055009 | Spondylosis |
| D013168 | Spondylolisthesis |
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
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| ID | Term |
|---|---|
| D055396 | Bone Morphogenetic Protein 2 |
| ID | Term |
|---|---|
| D019485 | Bone Morphogenetic Proteins |
| D055411 | TGF-beta Superfamily Proteins |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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