By InvitationNot Applicable

INDUCE: A Prospective 2-Year Spine Registry

United States1,000 participantsStarted 2026-02-17

Plain-language 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 lumbar spine. The secondary objective is to assess patient reported outcomes following the use of NMP in the treatment of the spine.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Fusion

Timeframe: 6 month and 12 month post surgery, and 24 month post surgery

Serious Adverse Events and Subsequent Surgical Interventions

Timeframe: Through study completion, an average of 2 years.

Trial details

NCT IDNCT06971835

SponsorRed Rock Regeneration Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-12

View on ClinicalTrials.gov More Subjects Treated With NMP as Part of Their Spine Surgery trials