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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- 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)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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)
时间窗: 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.
次要结局
- Back pain visual analogue scale(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)
- 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)
- 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)
- Leg pain visual analogue scale(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)
- 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)