By InvitationNot Applicable

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

United States200 participantsStarted 2024-01-04

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Incidence of interbody fusion

Timeframe: Baseline to 12 months post-operative

Incidence of secondary surgical intervention

Timeframe: Baseline to 12 months post-operative

Incidence of Adverse Product Related Events

Timeframe: Baseline to 12 months post-operative

Trial details

NCT IDNCT06000319

SponsorInduce Biologics USA Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-02-01

View on ClinicalTrials.gov More Degenerative Disc Disease trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.