Multicentric, Prospective Study of Efficacy and Safety of Lumbar Interbody Fusion With MatriTMBONE Associated With Autologous Marrow
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- patients' proportion which an intervertebral fusion
研究概览
简要总结
The main objective of this clinical study is the estimation of the rate of intersomatic fusion observed 12 months after lumbar interbody fusion by posterior approach with PEEK interbody cage of fusion in PEEK performed with autologous bone of decortication and osseous substitute with a biomaterial (MatriBONE associated with the autologous bone marrow), associated with a posterolateral bone graft performed with MatriBone waxed with bone marrow. Indication is dedicated for patients by painful degenerative osteoarthritis, by narrow lumbar canal and\or spondylolisthesis.
详细描述
This clinical study corresponds to a TLIF surgery using a per-operating artificial substitute specific biomaterial: autologous osteoblasts punctured on iliac crest and put on a collagen support waxed with tri-calcium phosphate (which is osteoconductive) to perform a intervertebral body fusion.
Biomaterial MATRITM BONE: Device of class III, with marking IT in the indication of arthrodesis. It will be administered during the lumbar interbody fusion's procedure.
The material is a matrix of collagen mineralized containing a homogeneous mixture of collagen cleansed of type I+III and an osseous biphasic substitute HA / TCP. The proportion of both constituents is 90 % of osseous substitute for 10 % of collagen en masse. The collagen is reduced in approximately 1 month and the osseous substitute leads to an osseous reshaping in 6 - 9 months approximately.
The follow up will last 12 months with 2 visits (6 and 12 months after surgery), 2 CT scan slides before inclusion and at 12 months, classical X-rays before inclusion and at 6 and 12 months, questionnaires (visual analogic scale for pain, and quality of life with OSWESTRY and SF36 scales) before inclusion and at 6 and 12 months, and biological exams (CRP/VS, for inflammation) at each visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 65 years old.
- •Body mass index lower than 35
- •Degenerative osteoarthritis painful and invalidating degenerative lumbar vertebra for at least 6 months and resistance fighter in the conservative treatment
- •Narrow lumbar canal and\or spondylolisthesis with neurological disorder associated with signs of primary instability or induced to neurological liberation
- •Patient requiring a surgery on a single interbody level.
- •Given informed consent
- •Patient with French health system
排除标准
- •For women: no efficient contraception (intra uterine device, or contraceptive pill)
- •Pregnant or feeding women
- •Surgery zone local infection local
- •Lumbar interbody fusion of more than two levels
- •Spondylolisthesis of high rank (stage 3 or 4 of the classification of Meyerding)
- •Scoliosis lumbar vertebra gives a complex to (Cobb angle> 40°)
- •All surgical contraindications
- •Severe hyperparathyroidism: calcium > 2,45 mmol/l and [PTH] ≥ 50pg / ml
- •Uncontrolled diabetes (untreated or non stabilized by treatment)
- •Long corticoid treatment (more than 6 months and stopped since less than 3 months)
- •Current Chemotherapy or during the last three months
- •Antecedent of regional radiotherapy
- •All contraindication to MatriTM BONE: osteomyelitis, bone degenerative disease or necrosis of surgery site.
- •Known turned out Osteoporosis untreated (dexa: > 2 DS)
- •Subject participating in another research including a period of always current exclusion in the pre-inclusion
- •Person placed under protection of justice
- •Severely altered physical and\or psychological Health, which according to, the investigator, can affect to participant's compliance to the study.
研究组 & 干预措施
TLIF surgery
干预措施: The Transforaminal Lumbar Interbody Fusion (TLIF) surgery (Procedure)
结局指标
主要结局
patients' proportion which an intervertebral fusion
时间窗: 12 months
The main assessment criteria of this study are patients' proportion which an intervertebral fusion is documented to CT scanners The intervertebral fusion is documented by the revealing of at least an osseous continuous span of a vertebral level in the other one on one of three CT scan slides centred on the cage.
次要结局
- NOTION OF TOLERANCE: Frequency and gravity of unwanted Adverse Events linked to the procedure and\or the use of the biomaterial(12 months)
- Quality of life evaluation(12 years)
- Evaluation of the pain(12 months)