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Enrolling by invitation NCT06000319

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

— Observational Degenerative Disc Disease Degenerative Spondylolisthesis Spinal Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Natural Matrix Protein (NMP) Fibers, Lumbar interbody fusion, Cervical interbody fusion.
Who it may be relevant to
Registry conditions: Degenerative Disc Disease, Degenerative Spondylolisthesis, Spinal Stenosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Incidence of interbody fusion [Time frame: Baseline to 12 months post-operative]
  • Incidence of secondary surgical intervention [Time frame: Baseline to 12 months post-operative]
  • Incidence of Adverse Product Related Events [Time frame: Baseline to 12 months post-operative]
Secondary outcome measures (7)
  • Incidence of bridging bone [Time frame: Baseline to 12 months post-operative]
  • Change in disability score for lumbar fusion patients assessed by Oswestry Disability Index [Time frame: Baseline to 12 months post-operative]
  • Change in disability score for cervical fusion patients assessed by Neck Disability Index [Time frame: Baseline to 12 months post-operative]
  • Change in back pain in lumbar fusion patients [Time frame: Baseline to 12 months post-operative]
  • Change in leg pain in lumbar fusion patients [Time frame: Baseline to 12 months post-operative]
  • Change in neck pain in cervical fusion patients [Time frame: Baseline to 12 months post-operative]
  • Change in arm pain in cervical fusion patients [Time frame: Baseline to 12 months post-operative]

Eligibility criteria

Inclusion criteria

  • Subject was diagnosed with DDD, spinal stenosis, or spondylolisthesis;
  • 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;
  • Subject has undergone cervical or lumbar interbody spine fusion using NMP Fibers;
  • Subject must be 18 years of age or older at the time of consent;
  • Subject must be willing and able to sign an informed consent document;
  • 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

  • Subject is under 18 years of age at the time of consent;
  • 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;
  • Subject is currently imprisoned.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Alabama Back Institute — Jasper

Identifiers

NCT: NCT06000319 · CT-NMP-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗