Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion

Prospective Evaluation of Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion

The aim of this study is to evaluate the effectiveness and safety of Natural Matrix Protein™ (NMP™) fibers when used in cervical or lumbar interbody fusion in patients with degenerative disc disease (DDD), spinal stenosis, spondylolisthesis undergoing cervical or lumbar interbody spine fusion at no more than 3 adjacent levels.

Study Overview

• Status: Not yet recruiting
• Conditions: Degenerative Disc Disease; Spinal Stenosis; Degenerative Spondylolisthesis
• Intervention / Treatment: Biological: Natural Matrix Protein (NMP) Fibers; Procedure: Lumbar interbody fusion; Procedure: Cervical interbody fusion

Detailed Description

The study involves a retrospective review of patients' medical records and prospective collection of X-rays, and patient outcome questionnaires.

The study population will include 100 consecutive lumbar interbody fusion and 100 consecutive cervical interbody fusion patients who meet the inclusion criteria and do not meet the exclusion criteria.

There will be 4 prospective study visits following consent. Follow-up will occur in accordance with standard of care practice and will continue to 12 months post-surgery

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Sean A Peel, Ph.D.; Phone Number: 416-898-9724; Email: sean.peel@redrockregen.com

Study Locations

• United States
  • Alabama
    • Jasper, Alabama, United States, 35501
      • Southern Orthopedic Sports Medicine Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will include up to 200 patients who have been treated with Induce Biologics NMP™ during cervical or lumbar interbody fusion. All subjects who meet all inclusion criteria and do not meet any exclusion criteria will be included in the study. It is expected that enrollment will take 12 months to complete.

Description

Inclusion Criteria:

1. Subject was diagnosed with DDD, spinal stenosis, or spondylolisthesis;
2. Subject has undergone cervical or lumbar interbody spine fusion at no more than 3 adjacent levels between C2 and T1 or between L1 and S1;
3. Subject has undergone cervical or lumbar interbody spine fusion using NMP Fibers;
4. Subject must be 18 years of age or older at the time of consent;
5. Subject must be willing and able to sign an informed consent document;
6. Subject must be willing and able to return to the study clinic for all follow-up visits, agree to participate in post-operative clinical and radiographic evaluations.

Exclusion Criteria:

1. Subject is under 18 years of age at the time of consent;
2. Subject is currently experiencing major mental illness (psychosis, schizophrenia, major affective disorder) which in the opinion of the investigator may indicate that the symptoms are psychological rather than of physical origin;
3. Subject is currently imprisoned.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lumbar Interbody Fusion with NMP; Subject has undergone lumbar interbody spine fusion at no more than 3 adjacent levels between L1 and S1 where NMP fibers have been used as a bone void filler	Biological: Natural Matrix Protein (NMP) Fibers; human bone allograft; Procedure: Lumbar interbody fusion; Procedure that involves removing the intervertebral disk from the disk space between between 2 or more vertebrae between L1 and S1. When the disk space has been cleared out, the surgeon fills the void between the vertebrae with a bone void filler.
Cervical Interbody Fusion with NMP; Subject has undergone cervical interbody spine fusion at no more than 3 adjacent levels between C2 and T1 where NMP fibers have been used as a bone void filler	Biological: Natural Matrix Protein (NMP) Fibers; human bone allograft; Procedure: Cervical interbody fusion; Procedure that involves removing the intervertebral disk from the disk space between between 2 or more vertebrae between C2 and T1. When the disk space has been cleared out, the surgeon fills the void between the vertebrae with a bone void filler.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of interbody fusion	Flexion and Extensions radiographs will be assessed for fusion at each level to be fused Fusion is defined as: (1) less than 5 degrees of motion by flexion extension X-ray and (2) no radiological features of non-union (radiolucency, implant migration, loss of graft height, supplemental fixation failure). Both fusion criteria have to be met to be considered a fusion success at the index level.	Baseline to 12 months post-operative
Incidence of secondary surgical intervention	Secondary surgical interventions (SSI) include revision, re-operation, removal, or supplemental fixation at the index levels	Baseline to 12 months post-operative
Incidence of Adverse Product Related Events	the incidence of the following will be reported: bone resorption with cage migration or subsidence, local inflammation with seromas, ectopic bone formation, radiculitis.	Baseline to 12 months post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of bridging bone	Plane radiographs will be evaluated for the presence of bridging bone at each level to be fused.	Baseline to 12 months post-operative
Change in disability score for lumbar fusion patients assessed by Oswestry Disability Index	Disability will be assessed using the Oswestry Disability Index (ODI). ODI is a questionnaire to collect a patient's responses to questions about perceived function (disability) in 10 everyday activities in patients with acute or chronic low back pain. Each question consists of 6 statements about 1 activity which are scored from 0 to 5. With 0 indicating the least disability and 5 the greatest. The scores are combined to a single score from 0 (no disability) to 50 (completely disabled)	Baseline to 12 months post-operative
Change in disability score for cervical fusion patients assessed by Neck Disability Index	Disability will be assessed using the Neck Disability Index (NDI). NDI is a questionnaire to collect a patient's responses to questions about perceived function (disability) in 10 everyday activities in patients with acute or chronic neck pain. Each question consists of 6 statements about 1 activity which are scored from 0 to 5. With 0 indicating the least disability and 5 the greatest. The scores are combined to a single score from 0 (no disability) to 50 (completely disabled)	Baseline to 12 months post-operative
Change in back pain in lumbar fusion patients	Pain will be assessed by Visual Analogue Scale (VAS) for back pain. VAS is a straight horizontal line of fixed length. The ends are defined as the extreme limits of the pain to be measured from the left (no pain) to the right (worst pain imaginable) and the patient marks on the line how much pain they are experiencing at that time. The VAS score is determined by measuring in millimeters from the end of the line to the point that the patient marks. The minimum score is 0 and the maximum score is 100. The larger the number the worse the pain being experienced	Baseline to 12 months post-operative
Change in leg pain in lumbar fusion patients	Pain will be assessed by Visual Analogue Scale (VAS) for back pain. VAS is a straight horizontal line of fixed length. The ends are defined as the extreme limits of the pain to be measured from the left (no pain) to the right (worst pain imaginable) and the patient marks on the line how much pain they are experiencing at that time. The VAS score is determined by measuring in millimeters from the end of the line to the point that the patient marks. The minimum score is 0 and the maximum score is 100. The larger the number the worse the pain being experienced.	Baseline to 12 months post-operative
Change in neck pain in cervical fusion patients	Pain will be assessed by Visual Analogue Scale (VAS) for back pain. VAS is a straight horizontal line of fixed length. The ends are defined as the extreme limits of the pain to be measured from the left (no pain) to the right (worst pain imaginable) and the patient marks on the line how much pain they are experiencing at that time. The VAS score is determined by measuring in millimeters from the end of the line to the point that the patient marks. The minimum score is 0 and the maximum score is 100. The larger the number the worse the pain being experienced.	Baseline to 12 months post-operative
Change in arm pain in cervical fusion patients	Pain will be assessed by Visual Analogue Scale (VAS) for back pain. VAS is a straight horizontal line of fixed length. The ends are defined as the extreme limits of the pain to be measured from the left (no pain) to the right (worst pain imaginable) and the patient marks on the line how much pain they are experiencing at that time. The VAS score is determined by measuring in millimeters from the end of the line to the point that the patient marks. The minimum score is 0 and the maximum score is 100. The larger the number the worse the pain being experienced.	Baseline to 12 months post-operative

Collaborators and Investigators

• Sponsor: Induce Biologics USA Inc.
• Investigators: Principal Investigator: Mark A Prevost Sr, MD, Southern Orthopedic Sports Medicine Associates; Principal Investigator: Mark A Prevost II, MD, Southern Orthopedic Sports Medicine Associates

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 25, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Intervertebral Disc Degeneration; Spinal Stenosis; Spondylolisthesis
• Other Study ID Numbers: CT-NMP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No