Natural Matrix Protein

NCT ID: NCT07217964

Last Updated: 2025-10-17

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-18
• Study Completion Date: 2027-09-17

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:

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. J Bone Joint Surg Am. 2011 Apr 20;93(8):705-15. doi: 10.2106/JBJS.I.00680. Epub 2011 Mar 11. PMID: 21398574.

Burkus JK, Heim SE, Gornet MF, Zdeblick TA. Is INFUSE bone graft superior to autograft bone? An integrated analysis of clinical trials using the LT-CAGE lumbar tapered fusion device. J Spinal Disord Tech. 2003 Apr;16(2):113-22. doi: 10.1097/00024720-200304000-00001. PMID: 12679664.

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).

References Fleiss, J. L., Levin, B., Paik, M.C. 2003. Statistical Methods for Rates and Proportions. Third Edition. John Wiley & Sons. New York.

Newcombe, R. G. 1998. 'Two-Sided Confidence Intervals for the Single Proportion: Comparison of Seven Methods.' Statistics in Medicine, 17, pp. 857-872.

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.

Conditions

Degenerative Lumbar Spinal Conditions

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

NMP graft with interbody cage

Radiographic Evaluation

Intervention Type: RADIATION

surgical procedure

Interventions

Radiographic Evaluation

surgical procedure

Intervention Type: RADIATION

Other Intervention Names

Surgical

Eligibility Criteria

Inclusion Criteria

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

-

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Gbolabo Sokunbi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Celeste Abjornson, PhD

Role: STUDY_DIRECTOR

Hospital for Special Surgery, New York

Locations

Hospital for Special Surgery

New York, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 31561556 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37071155 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30074971 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26378347 (View on PubMed)

Other Identifiers

2024-2081

Identifier Type: -

Identifier Source: org_study_id