Assessing Safety of Cervical Spine Fusion With NMP®
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRed Rock Regeneration Inc.
About this trial
The goal of this retrospective chart review study is to assess safety of NMP® in the treatment of cervical spine degenerative conditions by assessing the incidence and nature of AEs in follow-up (minimum of 90 days and up to 2 year post-operatively) as well as reoperation rates.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients treated with NMP® for Cervical (C2-T1) Interbody fusion (2022-2025) at the study site.
Minimum of 90-day post-operative follow up data available
Disqualifiers
Patients with no follow-up data within 3 months from the surgery date due to missed postoperative appointments.
Trial population
The study population will include up to 300 patients who have been treated with Induce Biologics NMP™ during cervical 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 4-5 months to complete.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Natural Matrix Protein (NMP) Fibers
Biological/VaccineHuman bone allograft
Cervical interbody fusion
Procedure/SurgeryProcedure 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.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Cervical Interbody Fusion with NMP2 interventions
Trial outcomes
Primary outcomes
1
Adverse Event Reporting
assessment of the incidence and nature of AEs. Complications determined to be related to NMP® within at least 3 months post-op will be collected and reported as part of the primary outcome of this study.
Time frame
90 days - 24 months postoperatively2
Re-operation Rates
Re-operation rates determined to be related to NMP® within at least 3 months post-op will be collected and reported as part of the primary outcome of this study.
Time frame
90 days - 24 months postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: