Degenerative Disc Disease, Spondylolisthesis, Spondylosis
Conditions
Keywords
ViviGen, Radiographic fusion rate, Anterior lumbar interbody fusion, Recombinant human bone morphogenetic protein-2, Spondylosis, Spondylolisthesis, Degenerative Disc Disease, Extreme lateral interbody fusion
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.
Interventions
OTHERViviGen®
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.
OTHERrhBMP-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.
Sponsors
Lindenhofgruppe AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes 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.
Intervention model description
The study is a prospective randomized assessor blind monocentric trial. It aims for non-inferiority.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 6 or 12 months after intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Back pain visual analogue scale | before intervention and at 6 weeks, 6 months and 12 months after intervention | 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 | before intervention and at 6 weeks, 6 months and 12 months after intervention | 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) | before intervention and at 6 weeks, 6 months and 12 months after intervention | 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) | before intervention and at 6 weeks, 6 months and 12 months after intervention | 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) | before intervention and at 6 weeks, 6 months and 12 months after intervention | 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) | 6 weeks, 6 months and 12 months after intervention | 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) | 14 days, 6 weeks, 6 months and 12 months after intervention | 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. |
Countries
Switzerland
Contacts
CONTACTDiel Peter, Dr. med
CONTACTKatia Schiegg
PRINCIPAL_INVESTIGATORDiel Peter, Dr. med.
Orthopädie Sonnenhof, Bern
Outcome results
None listed