Prospective Randomized Comparative Study of Interbody Bone Fusion Between Two Osteoinductive Bioactive Bone Substitutes After Anterior Lumbar Interbody Arthrodesis in Degenerative Lumbar Disc Surgery in Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in the Oswestry Disability Index (ODI) score from baseline (preoperative assessment) to 12 months following lumbar spinal fusion surgery for disc degeneration in adult patients.
研究概览
简要总结
Disc degeneration is a progressive deterioration process of the intervertebral disc, which can manifest as significant low back pain and a loss of mobility that interferes with daily activities. This condition is naturally age-related and exacerbated by traumatic events, lifestyle factors, and individual genetic susceptibilities. Treatment for advanced disc degeneration typically involves surgery (spinal fusion) aimed at addressing and fusing the affected intervertebral discs using an interbody implant combined with a bone graft.
Although the use of interbody implants promotes temporary fusion, long-term success largely depends on the bone substitute used, with failure rates ranging from 10 to 20% (unsuccessful fusion, persistent symptoms, need for reoperation). Historically, autologous bone grafting was the standard, but it carries disadvantages related to pain and invasiveness. Synthetic, bioactive bone substitutes are now used, although their effectiveness varies.
Animal studies support the hypothesis that a new substitute based on specific osteo-immunology technology (MagnetOs, Kuros) could offer superior results compared to autologous bone grafts and competing osteo-inductive materials, while being minimally invasive. This study aims to evaluate its properties in terms of bone fusion and its impact on functional scores in patients, hypothesizing a significant improvement in fusion rates and functional scores with this new substitute.
详细描述
Degenerative lumbar spine disease increasingly relies on surgery to treat and fuse one or more pathological intervertebral discs. The transabdominal retroperitoneal, or anterior, approach allows full access to and treatment of the diseased disc, enabling a more physiological restoration of spinal alignment. Implants placed in the interbody position provide immediate vertebral stabilization, while the bone graft or bone substitute added to the interbody implant enables long-term fusion through neo-ossification of the segment.
The quality and speed of fusion achieved largely depend on the bone substitute used, and this fusion is a key factor in obtaining good functional outcomes for the patient. In approximately 10 to 20% of cases, this fusion does not succeed, resulting in persistent pain symptoms and potentially requiring reoperation.
Historically, to achieve this fusion, autologous bone was harvested from another anatomical site, most often the iliac crest. This autologous bone graft requires an additional incision, which is often associated with pain and discomfort. For these reasons, synthetic or biologic bone substitutes have been developed by pharmaceutical engineering to avoid bone harvesting, and are now routinely used in clinical practice.
To date, many bioactive bone substitutes have obtained marketing authorization, but their effectiveness varies depending on their physicochemical composition. It is accepted that the fusion rate could improve by up to 60% depending on the bone substitute used.
Animal studies support the hypothesis that a new bone substitute, referred to here as Substitute A, based on specific osteoimmunology technology (MagnetOs, Kuros), is equivalent to the current gold standard (autologous bone graft) in terms of achieved fusion, and superior to competing osteoinductive products that are routinely used at Montpellier University Hospital and in most other hospitals to achieve spinal fusion (6). This suggests the possibility of achieving equivalent outcomes through a faster, less invasive, less painful procedure with no limitation on the volume of substitute used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 80 years inclusive
- •Oswestry Disability Index (ODI) >25
- •Chronic low back pain and/or radicular pain lasting for more than 6 months
- •Failure of medical and rehabilitative treatment
- •Patient presenting with one of the following: grade 1 degenerative spondylolisthesis without isthmic lysis, or disc degeneration, or mixed pathology (degeneration and lumbar stenosis)
- •Patient eligible for anterior approach spinal fusion surgery with interbody cage
排除标准
- •History of spinal surgery at the lumbar level, excluding isolated discectomies for disc herniation
- •Confirmed osteoporosis
- •Surgical fusion at an adjacent level
- •Contraindication to Magnetos Putty or GlassBone Putty:
- •Use of medications interfering with calcium metabolism
- •Severe systemic or metabolic bone disorders affecting bone healing or lesions
- •Untreated acute or chronic infection requiring appropriate therapy
- •Patients with severe trauma and open external wounds near the defect site, at risk of infection
- •Known allergy to bioactive glass or its components (Ca2+, PO43-, Na+, and Si(OH)4), polyethylene glycol, and/or glycerol
- •Patients who have undergone or will undergo chemotherapy or radiotherapy at or near the implantation site
- •Severe renal or hepatic infections
- •Unrepaired dural tear in craniospinal surgery
- •Patients requiring placement of more than one implant
- •Subject unable to read and/or write fluent French, or illiterate
- •Subject already participating in another interventional clinical trial that could interfere with this study
- •Uncontrolled psychiatric illness
- •Lack of written informed consent after a reflection period
- •Individuals with a dependency or employment relationship with the sponsor or investigator
- •Subject enrolled in another study with an ongoing exclusion period (Article L1121-12)
- •Subject not affiliated with or not a beneficiary of the French social security system (L1121-8-1)
- •Protected populations under French Public Health Code:
- •Pregnant or breastfeeding women (L. 1121-5)
- •Individuals deprived of liberty (art. L. 1121-6) (by judicial, administrative decision or involuntary hospitalization)
- •Protected adults (under guardianship, curatorship, or legal protection) (L. 1121-8)
- •Women planning to become pregnant within the year
研究组 & 干预措施
Intervention group : Interbody fusion with bone substitute Magnetos Putty, Kuros medical
Subjects randomly assigned to the intervention group will benefit from Magnetos Putty, Kuros during surgery
干预措施: Use of bone substitute during intervertebral fusion surgery (Device)
Control group : Interbody fusion with conventional bone substitute GlassBone Putty, Noraker
Subjects randomly assigned to the control group will benefit from GlassBone Putty, Noraker during surgery
干预措施: Use of bone substitute during intervertebral fusion surgery (Device)
结局指标
主要结局
Change in the Oswestry Disability Index (ODI) score from baseline (preoperative assessment) to 12 months following lumbar spinal fusion surgery for disc degeneration in adult patients.
时间窗: Baseline to 12 months post-surgery
The primary efficacy endpoint will assess functional disability improvement by measuring the variation in ODI score between the preoperative evaluation and the 12-month postoperative follow-up. The ODI is a self-administered questionnaire used to assess the degree of disability related to low back pain. It consists of 10 sections, each scored from 0 to 5, resulting in a total score ranging from 0 (no disability) to 50 (maximum disability).
次要结局
- Assessment of interbody fusion at 12 months using CT scan.(12 months post-surgery)
- Evaluation of pain and functional disability using Visual Analog Scale (VAS) for low back and radicular pain at 3 and 12 months postoperatively.(3 months and 12 months post-surgery)
- Oswestry Disability Index (ODI) at 3 and 12 months.(3 months and 12 months post-surgery)
- Use of analgesic and anti-inflammatory medications (steroidal and non-steroidal) at 3 and 12 months postoperatively.(3 months and 12 months post-surgery)
- Rate of patient return to work at 3 and 12 months postoperatively(3 months and 12 months post-surgery)
- Time to resumption of activity within 12 months(From surgery to 12 months postoperatively)
- Rate of re-hospitalization within 3 months following the surgical intervention.(Within 3 months post-surgery)
- Reoperation at the initial surgical site during the 12-month follow-up period.(Within 12 months post-surgery)