Prospective Evaluation of Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of interbody fusion
研究概览
简要总结
The aim of this study is to evaluate the effectiveness and safety of Natural Matrix Protein™ (NMP™) fibers when used in cervical or lumbar interbody fusion in patients with degenerative disc disease (DDD), spinal stenosis, spondylolisthesis undergoing cervical or lumbar interbody spine fusion at no more than 3 adjacent levels.
详细描述
The study involves a retrospective review of patients' medical records and prospective collection of X-rays, and patient outcome questionnaires.
The study population will include 100 consecutive lumbar interbody fusion and 100 consecutive cervical interbody fusion patients who meet the inclusion criteria and do not meet the exclusion criteria.
There will be 4 prospective study visits following consent. Follow-up will occur in accordance with standard of care practice and will continue to 12 months post-surgery
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject was diagnosed with DDD, spinal stenosis, or spondylolisthesis;
- •Subject has undergone cervical or lumbar interbody spine fusion at no more than 3 adjacent levels between C2 and T1 or between L1 and S1;
- •Subject has undergone cervical or lumbar interbody spine fusion using NMP Fibers;
- •Subject must be 18 years of age or older at the time of consent;
- •Subject must be willing and able to sign an informed consent document;
- •Subject must be willing and able to return to the study clinic for all follow-up visits, agree to participate in post-operative clinical and radiographic evaluations.
排除标准
- •Subject is under 18 years of age at the time of consent;
- •Subject is currently experiencing major mental illness (psychosis, schizophrenia, major affective disorder) which in the opinion of the investigator may indicate that the symptoms are psychological rather than of physical origin;
- •Subject is currently imprisoned.
研究组 & 干预措施
Lumbar Interbody Fusion with NMP
Subject has undergone lumbar interbody spine fusion at no more than 3 adjacent levels between L1 and S1 where NMP fibers have been used as a bone void filler
干预措施: Natural Matrix Protein (NMP) Fibers (Biological)
Lumbar Interbody Fusion with NMP
Subject has undergone lumbar interbody spine fusion at no more than 3 adjacent levels between L1 and S1 where NMP fibers have been used as a bone void filler
干预措施: Lumbar interbody fusion (Procedure)
Cervical Interbody Fusion with NMP
Subject has undergone cervical interbody spine fusion at no more than 3 adjacent levels between C2 and T1 where NMP fibers have been used as a bone void filler
干预措施: Natural Matrix Protein (NMP) Fibers (Biological)
Cervical Interbody Fusion with NMP
Subject has undergone cervical interbody spine fusion at no more than 3 adjacent levels between C2 and T1 where NMP fibers have been used as a bone void filler
干预措施: Cervical interbody fusion (Procedure)
结局指标
主要结局
Incidence of interbody fusion
时间窗: Baseline to 12 months post-operative
Flexion and Extensions radiographs will be assessed for fusion at each level to be fused Fusion is defined as: (1) less than 5 degrees of motion by flexion extension X-ray and (2) no radiological features of non-union (radiolucency, implant migration, loss of graft height, supplemental fixation failure). Both fusion criteria have to be met to be considered a fusion success at the index level.
Incidence of secondary surgical intervention
时间窗: Baseline to 12 months post-operative
Secondary surgical interventions (SSI) include revision, re-operation, removal, or supplemental fixation at the index levels
Incidence of Adverse Product Related Events
时间窗: Baseline to 12 months post-operative
the incidence of the following will be reported: bone resorption with cage migration or subsidence, local inflammation with seromas, ectopic bone formation, radiculitis.
次要结局
- Change in neck pain in cervical fusion patients(Baseline to 12 months post-operative)
- Change in arm pain in cervical fusion patients(Baseline to 12 months post-operative)
- Incidence of bridging bone(Baseline to 12 months post-operative)
- Change in disability score for lumbar fusion patients assessed by Oswestry Disability Index(Baseline to 12 months post-operative)
- Change in disability score for cervical fusion patients assessed by Neck Disability Index(Baseline to 12 months post-operative)
- Change in back pain in lumbar fusion patients(Baseline to 12 months post-operative)
- Change in leg pain in lumbar fusion patients(Baseline to 12 months post-operative)