Clinical trial · Observational
Bone Graft Materials Observational Registry
A Prospective Patient Registry for Bone Graft Substitutes in Spinal Fusion: Patient Outcomes and Use in Clinical Practice
NCT00974623CI-TRIAL-00026799APPROACH-001terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Parent sponsor company (Baxter Healthcare) company cut funding
Summary
Brief summary (as posted)
A multi-center, prospective, observational patient registry to collect information on the clinical outcomes and "real world" use of approved and commercially available bone graft substitutes, autograft and allograft.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Myelopathy | — | UNRESOLVED | — |
| Degenerative Disc Disease | — | UNRESOLVED | — |
| Failed Back Surgery Syndrome | — | UNRESOLVED | — |
| Herniated Disc | — | UNRESOLVED | — |
| Spinal Cord Neoplasms | Spinal Cord Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Spinal Deformity | — | UNRESOLVED | — |
| Spinal Stenosis | — | UNRESOLVED | — |
| Spondylolithesis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bone graft substitute, autograft or allograft | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Spinal Fusion
- description
- Patients who undergo a planned spinal fusion procedure requiring approved bone grafting materials (e.g., bone grft substitutes, allograft or autograft).
- interventionNames
- Device: Bone graft substitute, autograft or allograft
Primary outcomes (1)
- measure
- Evidence of successful radiographic fusion
- timeFrame
- 6 months, 12 months & 24 months
Secondary outcomes (2)
- measure
- Maintenance or improvement in neurological status, as compared to baseline scores
- timeFrame
- 6 months 12 months & 24 months
- measure
- Improvement of pain/function in comparison to pre-operative QOL scores
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The patient has failed conservative treatment and is a candidate for spinal fusion surgery. * The patient is ≥18 years old and of legal age of consent. * The patient is, in the investigator's opinion, psychosocially, mentally, and physically able to fully comply with this protocol, including the post-operative regimen, required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent. * The patient is skeletally mature (epiphyses closed). * The patient has signed the IRB approved informed consent. * The patient is willing and able to participate in post-operative clinical and radiographic follow up evaluations for 2 years. Exclusion Criteria: * Patient has systemic infection or infection at the surgical site. * Patient has a medical condition that would interfere with post-operative assessments and care (i.e., neuromuscular disease, psychiatric disease, paraplegia, quadriplegia, etc.). * Patient is in poor general health or any concurrent disease process that would place the patient in excessive risk to surgery (i.e., significant circulatory or pulmonary problems, or cardiac disease). * Patient has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the patient's ability to complete the protocol required follow-up. * The patient is pregnant/breastfeeding at the time of enrollment, or plans to become pregnant during the course of the study. * Patient is participating in another investigational study, which could confound results.
References
Publications (0)
Data not yet available
No reference posted for this study.