Comparison of Radiographic Fusion Rate and Clinical Outcome of ALIF and XLIF Performed with Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen®
- Conditions
- SpondylolisthesisDegenerative Disc DiseaseSpondylosis
- Interventions
- Other: ViviGen®Other: rhBMP-2
- Registration Number
- NCT05238740
- Lead Sponsor
- Lindenhofgruppe AG
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 168
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group 5-5.4 cc ViviGen® ViviGen® 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® Control group 4-6mg rhBMP-2 rhBMP-2 Biological: 4-6mg rhBMP-2The stand-alone ALIF L5/S1 fusion patients assigned to this group will receive 4-6mg rhBMP-2
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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.
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.
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 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.
Trial Locations
- Locations (1)
Orthopädie Sonnenhof
🇨🇭Bern, Switzerland