By InvitationNot Applicable

Natural Matrix Protein

United States100 participantsStarted 2025-03-18

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

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: * Patients experiencing symptomatic lumbar degenerative disc disease who failed conservative management at up to four vertebral levels between L1-S1 between February 2024 and December 2024. * Adult patients (≥ 18 years old) who underwent lumbar fusion with an NMP graft and interbody cage Exclusion Criteria: * Previous lumbar fusion attempts at the level of surgery (adjacent lumbar levels are acceptable) * Active Malignancy * Concurrently under chemotherapy * Active infection at time of surgery * Mentally compromised * Trauma to the operated region

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Radiographs

Timeframe: From May 2025 until May 2027

Trial details

NCT IDNCT07217964

SponsorHospital for Special Surgery, New York

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-03-17

View on ClinicalTrials.gov More Degenerative Lumbar Spinal Conditions trials