Natural Matrix Protein (NMP)

June 4, 2026 updated by: Gbolabo Sokunbi, Hospital for Special Surgery, New York

Evaluating Natural Matrix Protein (NMP) in Lumbar Spinal Fusion

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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:

Length of constructs with note of non-contiguous constructs Levels treated Patient Assessments and Questionnaires prior to surgery Type and brand of interbody implant(s) used (if applicable) Induce and other bone graft materials used Adverse Events (defined in section 3.5) Description of adverse events Radiographic imaging at pre-operative, discharge, and follow-up time points of 6 months post-operatively (as available)

Prospective Data Collection:

Patients will be consented at their 12 month follow-up to participate in the clinical study. Clinical and radiographic data will be collected.

12 month radiographic data (SOC x-rays and CTs) Patient Assessment Questionnaires Surgeon Assessment of Patient Classification of any Secondary Surgical Procedures Adverse Events If patient has not achieved fusion, patient will be asked if they would be willing to follow-up at 24 months

Radiographic Assessment Imaging assessments will be performed by an independent imaging reviewer. The reviewer will be a musculoskeletal radiologist. The reviewer will be trained on 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, 1-year follow-up, and 2-year follow-up (if available) will be utilized. 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 and in accordance to FDA guidance. The following grading system was implemented:

Not Fused: Absence of bridging bone from endplate to endplate in the intervertebral space, or angular motion > 3 degrees, or translational motion > 2 mm.

Fused: Presence of bridging bone from endplate to endplate in the intervertebral space, angular motion ≤ 3 degrees, and translational motion ≤ 2mm.

Retrospective-prospectively collected data will be recorded from subject electronic medical records

Study enrollment consists of 100 consecutive subjects who have consented to the study.

Statistical Analysis:

A performance goal methodology will be utilized to assess the primary outcome of fusion rate compared to literature controls. A literature review was conducted to find appropriate comparative studies that had similar criteria for the assessment of fusion for the performance model. The following studies are 1 level and 2 level lumbar interbody fusion studies that we used as the comparators:

Fairbank J. Re: Zigler J, Delamarter R, Spivak J, et al. Results of the prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential fusion for the treatment of 1-level degenerative disc disease. Spine 2007;32:1155-62. Spine (Phila Pa 1976). 2007 Dec 1;32(25):2929-30; author reply 2930-1. doi: 10.1097/BRS.0b013e31815b84ca. PMID: 18246024.

Delamarter R, Zigler JE, Balderston RA, Cammisa FP, Goldstein JA, Spivak JM. Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement compared with circumferential arthrodesis for the treatment of two-level lumbar degenerative disc disease: results at twenty-four months.

From this modelling, our primary outcome performance goal would be an 96% fusion rate with a confidence interval of 93-99%.

Sample size calculation A total sample of 101 patients is needed for this study to estimate a fusion rate of 0.96 with two-sided 95% confidence interval of (0.93,0.99).

Statistical analysis plan Counts and percentages of fusion status will be summarized. 95% confidence interval for the proportion estimate will also be calculated. VAS satisfaction and ODI score will be summarized as mean and standard deviation, or median and IQR based on the distribution of them.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

hospital patients

Description

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 2024.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult patients (≥ 18 years old) who underwent lumbar fusion
NMP graft with interbody cage
Radiation: Radiographic Evaluation
surgical procedure
Other Names:
  • Surgical

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From May 2025 until May 2027

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery, New York

Investigators

  • Study Director: Celeste Abjornson, PhD, Hospital for Special Surgery, New York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2025

Primary Completion (Estimated)

March 17, 2027

Study Completion (Estimated)

September 17, 2027

Study Registration Dates

First Submitted

October 15, 2025

First Submitted That Met QC Criteria

October 15, 2025

First Posted (Actual)

October 20, 2025

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-2081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

data is aggragated for reporting

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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