Natural Matrix Protein

NCT07217964 | Enrolling By Invitation

• 1 other identifier: 2024-2081
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Degenerative Lumbar Spinal Conditions

Keywords

Lumbar; Natural Matrix Protein; Fusion; Allograft

Outcome Measures

Primary Outcomes (1)

• Radiographs

  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

Study Arms (1)

Adult patients (≥ 18 years old) who underwent lumbar fusion

NMP graft with interbody cage

Radiation: Radiographic Evaluation

Interventions

Radiographic Evaluation RADIATION

surgical procedure

Also known as: Surgical

Adult patients (≥ 18 years old) who underwent lumbar fusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

hospital patients

You may qualify if:

• \. Adult patients (≥ 18 years old) who underwent lumbar fusion with an NMP graft and interbody cage

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (4)

• D'Souza M, Macdonald NA, Gendreau JL, Duddleston PJ, Feng AY, Ho AL. Graft Materials and Biologics for Spinal Interbody Fusion. Biomedicines. 2019 Sep 26;7(4):75. doi: 10.3390/biomedicines7040075.

  PMID: 31561556 BACKGROUND

• Rathbone J, Rackham M, Nielsen D, Lee SM, Hing W, Riar S, Scott-Young M. A systematic review of anterior lumbar interbody fusion (ALIF) versus posterior lumbar interbody fusion (PLIF), transforaminal lumbar interbody fusion (TLIF), posterolateral lumbar fusion (PLF). Eur Spine J. 2023 Jun;32(6):1911-1926. doi: 10.1007/s00586-023-07567-x. Epub 2023 Apr 18.

  PMID: 37071155 BACKGROUND

• Martin BI, Mirza SK, Spina N, Spiker WR, Lawrence B, Brodke DS. Trends in Lumbar Fusion Procedure Rates and Associated Hospital Costs for Degenerative Spinal Diseases in the United States, 2004 to 2015. Spine (Phila Pa 1976). 2019 Mar 1;44(5):369-376. doi: 10.1097/BRS.0000000000002822.

  PMID: 30074971 BACKGROUND

• Fehlings MG, Tetreault L, Nater A, Choma T, Harrop J, Mroz T, Santaguida C, Smith JS. The Aging of the Global Population: The Changing Epidemiology of Disease and Spinal Disorders. Neurosurgery. 2015 Oct;77 Suppl 4:S1-5. doi: 10.1227/NEU.0000000000000953.

  PMID: 26378347 BACKGROUND

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• Celeste Abjornson, PhD

  Hospital for Special Surgery, New York

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 15, 2025
• First Posted: October 20, 2025
• Study Start: March 18, 2025
• Primary Completion (Estimated): March 17, 2027
• Study Completion (Estimated): September 17, 2027
• Last Updated: October 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)