Evaluating Natural Matrix Protein (NMP) in Lumbar Spinal Fusion
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Radiographs
研究概览
简要总结
This clinical study is a non-randomized, consecutive, single-center, retrospective-prospective investigation of patients who received NMP bioimplant (Induce Biologics, Tampa, FL) in lumbar spinal fusion procedures. The purpose of this study is to assess the radiographic, clinical, and safety outcomes of Natural Matrix Protein (NMP) as a graft alternative in lumbar fusion procedures.
Utilizing the Hospital for Special Surgery's EPIC database under Institutional Review Board approval, all patients with symptomatic lumbar degenerative disc disease who failed conservative management at up to four vertebral levels between L1-S1 between February 2024 and December 2025 will be reviewed.
The inclusion criteria for the study will be adult patients (≥ 18 years old) who underwent lumbar fusion with an NMP graft and interbody cage. The exclusion criteria will include previous lumbar fusion attempts, active malignancy, concurrently under chemotherapy, active infection at time of surgery, mentally compromised, and trauma to the operated region. It is expected approximately 100 patients will fit the inclusion/exclusion criteria.
The objective of the study is to evaluate the clinical outcomes of the subjects treated with NMP
详细描述
Retrospective Data Collection:
Patient data was collected into a data sheet to collect specific elements that relate to safety and efficacy of the procedure utilizing this specific device system. The data elements of interest are:
Patient Summary data (where appropriate: average, sd, range):
Subject demographics Distribution of primary diagnoses
Surgical Information:
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
- 是
入选标准
- •Patients experiencing symptomatic lumbar degenerative disc disease who failed conservative management at up to four vertebral levels between L1-S1 between February 2024 and December
- •Adult patients (≥ 18 years old) who underwent lumbar fusion with an NMP graft and interbody cage
排除标准
- •Previous lumbar fusion attempts at the level of surgery (adjacent lumbar levels are acceptable)
- •Active Malignancy
- •Concurrently under chemotherapy
- •Active infection at time of surgery
- •Mentally compromised
- •Trauma to the operated region
结局指标
主要结局
Radiographs
时间窗: From May 2025 until May 2027
Radiographic: Imaging assessments will be performed by an independent imaging reviewer. The reviewer will be a musculoskeletal radiologist trained in the schedule of imaging assessments and classification systems for performing each assessment. The reviewer will not have access to clinical outcome data. Plain lateral radiographs at baseline, immediate postoperative, 6-month follow-up, and 1-year follow-up. All radiological measurements will be made using Sectra IDS7 (Sectra AB, Linköping, Sweden). Fusion status on radiographs will be graded at each treated segment from an analysis of three components: bridging bone between the vertebral bodies, angular motion, and translational motion. Fusion Status measured on radiographs was derived from the qualitative assessment of bridging bone and the quantitative assessments of angular and translational Motion. The following grading system was implemented: Not Fused: Absence of bridging bone from endplate to endplate
次要结局
未报告次要终点
研究者
Gbolabo Sokunbi
MD
Hospital for Special Surgery, New York