Back to resultsComparison of Standalone Anterior Lumbar Interbody Fusion (ALIF) L5/S1 Performed With Either rhBMP-2 or ViviGen®
Primary Purpose
Spondylosis, Spondylolisthesis, Degenerative Disc Disease
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
ViviGen®
rhBMP-2
Sponsored by
About this trial
This is an interventional other trial for Spondylosis focused on measuring ViviGen, Radiographic fusion rate, Anterior lumbar interbody fusion, Recombinant human bone morphogenetic protein-2, Spondylosis, Spondylolisthesis, Degenerative Disc Disease
Eligibility Criteria
Inclusion Criteria:
Patients that present the indication for performing ALIF procedure L5/S1, e.g.,treating conditions such as spondylosis, spondylolisthesis and degenerative disc disorders with back and/or leg pain
- Patients must be 18 -65 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 65 of age
- Patients with tumor/ spinetrauma/ known bone disease / parkinsons disease and similar CNS disorders / diseases or injuries of the peripheral nerves
- Smoking
- Pregnant or breastfeeding patients
- inadequate communication skills (IC F, D)
- 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
Sites / Locations
- Orthopädie SonnenhofRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Intervention group 5-5.4 cc ViviGen®
Control group 4-6mg rhBMP-2
Arm Description
Biological: 5-5.4 cc ViviGen®The stand-alone ALIF L5/S1 fusion patients assigned to this group will receive 5-5.4 cc ViviGen®
Biological: 4-6mg rhBMP-2The stand-alone ALIF L5/S1 fusion patients assigned to this group will receive 4-6mg rhBMP-2
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05238740
Brief Title
Comparison of Standalone Anterior Lumbar Interbody Fusion (ALIF) L5/S1 Performed With Either rhBMP-2 or ViviGen®
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 27, 2022 (Actual)
Primary Completion Date
November 2026 (Anticipated)
Study Completion Date
November 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lindenhofgruppe AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 standalone ALIF procedure L5/S1
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study is a prospective randomized assessor blind monocentric trial. It aims for non-inferiority.
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
168 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group 5-5.4 cc ViviGen®
Arm Type
Active Comparator
Arm Description
Biological: 5-5.4 cc ViviGen®The stand-alone ALIF L5/S1 fusion patients assigned to this group will receive 5-5.4 cc ViviGen®
Arm Title
Control group 4-6mg rhBMP-2
Arm Type
Active Comparator
Arm Description
Biological: 4-6mg rhBMP-2The stand-alone ALIF L5/S1 fusion patients assigned to this group will receive 4-6mg rhBMP-2
Intervention Type
Other
Intervention Name(s)
ViviGen®
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
rhBMP-2
Other Intervention Name(s)
InductOS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of interbody bony fusion in the lumbar segment L5/S1 using Brantigan, Steffee, Fraser (BSF)
Description
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.
Time Frame
12 months after intervention
Secondary Outcome Measure Information:
Title
Back pain visual analogue scale
Description
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.
Time Frame
before intervention and at 6 weeks, 6 months and 12 months after intervention
Title
Leg pain visual analogue scale
Description
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.
Time Frame
before intervention and at 6 weeks, 6 months and 12 months after intervention
Title
Quality of life using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score)
Description
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.
Time Frame
before intervention and at 6 weeks, 6 months and 12 months after intervention
Title
Disability/ limitations in the activities of daily living using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score)
Description
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.
Time Frame
before intervention and at 6 weeks, 6 months and 12 months after intervention
Title
Disability/ limitations at the workplace using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score)
Description
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.
Time Frame
before intervention and at 6 weeks, 6 months and 12 months after intervention
Title
Patient satisfaction using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score)
Description
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.
Time Frame
6 weeks, 6 months and 12 months after intervention
Title
Complication / side effects using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score)
Description
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.
Time Frame
14 days, 6 weeks, 6 months and 12 months after intervention
Other Pre-specified Outcome Measures:
Title
Healthcare-costs using hospitalisation length of stay (LOS), occurrence and therapy of side effects/ adverse events and necessary revision operations
Description
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.
Time Frame
12 months after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diel Peter, Dr. med
Phone
+41 31 358 17 90
Email
peter.diel@sonnenhof.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Sabine Berger
Phone
+41 79 328 50 24
Email
sabine.berger@lindenhofgruppe.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diel Peter, Dr. med.
Organizational Affiliation
Orthopädie Sonnenhof, Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopädie Sonnenhof
City
Bern
ZIP/Postal Code
3006
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Diel, Dr.med.
Phone
+41 31 358 17 90
Email
peter.diel@sonnenhof.ch
First Name & Middle Initial & Last Name & Degree
Sabine Berger
Phone
+41793285024
Email
sabine.berger@lindenhofgruppe.ch
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
8769465
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.
Results Reference
background
PubMed Identifier
22241610
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.
Results Reference
background
PubMed Identifier
32355628
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.
Results Reference
background
PubMed Identifier
27909654
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.
Results Reference
background
PubMed Identifier
30872148
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.
Results Reference
background
PubMed Identifier
24026158
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.
Results Reference
background
PubMed Identifier
33213484
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.
Results Reference
background
Learn more about this trial
Comparison of Standalone Anterior Lumbar Interbody Fusion (ALIF) L5/S1 Performed With Either rhBMP-2 or ViviGen®
We'll reach out to this number within 24 hrs