Evaluating Natural Matrix Protein (NMP) in Lumbar Spinal Fusion
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Radiographs
Study Overview
Brief Summary
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
Detailed Description
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:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Adult patients (≥ 18 years old) who underwent lumbar fusion
NMP graft with interbody cage
Intervention: Radiographic Evaluation (Radiation)
Outcomes
Primary Outcomes
Radiographs
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
Gbolabo Sokunbi
MD
Hospital for Special Surgery, New York