Clinical trial NCT06000319: Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion
Official title: Prospective Evaluation of Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Degenerative Disc Disease
Degenerative Spondylolisthesis
Spinal Stenosis
Lead sponsor: Induce Biologics USA Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of interbody fusion
timeFrame: Baseline to 12 months post-operative
measure: Incidence of secondary surgical intervention
timeFrame: Baseline to 12 months post-operative
measure: Incidence of Adverse Product Related Events
timeFrame: Baseline to 12 months post-operative
Secondary outcomes:
measure: Incidence of bridging bone
timeFrame: Baseline to 12 months post-operative
measure: Change in disability score for lumbar fusion patients assessed by Oswestry Disability Index
timeFrame: Baseline to 12 months post-operative
measure: Change in disability score for cervical fusion patients assessed by Neck Disability Index
timeFrame: Baseline to 12 months post-operative
measure: Change in back pain in lumbar fusion patients
timeFrame: Baseline to 12 months post-operative
measure: Change in leg pain in lumbar fusion patients
timeFrame: Baseline to 12 months post-operative
measure: Change in neck pain in cervical fusion patients
timeFrame: Baseline to 12 months post-operative
measure: Change in arm pain in cervical fusion patients
timeFrame: Baseline to 12 months post-operative
Other outcomes:
Locations:
city: Jasper
country: United States
facility: Alabama Back Institute
state: Alabama
Study officials:
affiliation: Alabama Back Institute
name: Mark A Prevost Sr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alabama Back Institute
name: Mark A Prevost II, MD
role: PRINCIPAL_INVESTIGATOR
References: