Status:
NOT_YET_RECRUITING
INDUCE: A Prospective 2-Year Spine Registry
Lead Sponsor:
Red Rock Regeneration Inc.
Conditions:
Subjects Treated With NMP as Part of Their Spine Surgery
Degenerative Disc Disease (DDD)
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective of this prospective, observational registry study is to evaluate the safety and effectiveness of Natural Matrix Protein® (NMP®) when used to promote fusion in the cervical or lum...
Detailed Description
This is a multicenter, observational, prospective registry study of up to 1,000 patients across a maximum of 10 US sites. All subjects who meet study entrance criteria and planned to be treated with N...
Eligibility Criteria
Inclusion
- Implanted on-label with NMP in at least one vertebral level in the cervical (C1-C7) or lumbar (L1-S1) spine as part of their surgery
- Total volume of bone graft or bone graft substitute used in index surgery must contain at least 50% NMP by volume per treated level, where NMP is mixed with other graft material.
- Skeletally mature (age≥18 years of age)
- Be willing to sign the study-specific informed consent document prior to index surgery
Exclusion
- Not willing to sign the study-specific informed consent document prior to index surgery
- Use of allogenic growth factor extacts (i.e. OsteoFactor/ProteiOS) or cell based allografts as part of the index surgery (use of autograft or bone marrow aspirate (BMA) is allowed)
- Use of rhBMP-2 (i.e. INFUSE) or synthetic peptide enhanced graft (i.e. iFactor) as part of the index surgery
- Diagnosis of spinal deformity (greater than 20 degrees) or vertebral fracture including treated level
- Unable to comply with postoperative standard of care imaging (e.g. pregnant or nursing female)
- Did not complete baseline patient reported outcomes prior to index surgery
- Incarcerated at the time of surgery or preoperative evaluation
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06971835
Start Date
October 1 2025
End Date
January 1 2029
Last Update
July 22 2025
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