Clinical trial · Observational
A Prospective Analysis of the Efficacy of Allosync Expand and Autograft Bone Graft in Open Lumbar Spinal Fusion
NCT06415110CI-TRIAL-00093975enrolling by invitationClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess the radiographic and clinical outcomes of spinal fusion following use of Allosync Expand and autograft bone graft.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Spondylolisthesis, Grade 1 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allosync Expand | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Allosync Expand
- description
- All enrolled patients will received Allosync Expand at 1-3 contiguous levels (L1-S1).
- interventionNames
- Device: Allosync Expand
Primary outcomes (1)
- measure
- Lumbar fusion rate assessed via CT
- timeFrame
- 12 months post surgery
- description
- Lumbar fusion rate assessed via CT at 12 months post surgery
Secondary outcomes (3)
- measure
- Clinical outcome via neck visual analog scale (VAS)
- timeFrame
- 12 months post surgery
- description
- Standard of care patient reported neck visual analog scale (VAS) will be used to evaluate patient pain. On a scale of 0 to 10 with a score of 0 being no pain and a score of 10 being worst pain. A low score means a better clinical outcome. A high score means a worse clinical outcome.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria: 1. At least 22years of age at the time of consent 2. Subject must have a documented diagnosis of spondylolisthesis up to Grade I. and have confirmed back and/or radicular pain with associated spinal stenosis as documented by conditions such as: 1. Instability as defined by \>3mm translation or \>5 degree angulation 2. Osteophyte formation of facet joints or vertebral endplates 3. Subject presents with one or more of the following: 1. Radiculopathy 2. Sensory deficit 3. Motor weakness 4. Reflex changes 4. Subject requires lumbar posterolateral arthrodesis at 1-3 contiguous levels (L1-S1). 5. The number of levels decompressed must equal the number of levels fused. 6. Subject must have been unresponsive to conservative care for at least 3 months prior to fusion surgery. 7. Subject must be willing and able to sign an informed consent document. 8. Subject must be willing and able to return for all follow-up visits, agree to participate in postoperative clinical and radiographic evaluations and comply with the required study regimen. Exclusion Criteria: 1. Subject has had prior lumbar spine fusion surgery at any level. 2. Subject has greater than grade 1 spondylolisthesis of the lumbar spine. 3. Subject is pregnant or nursing or planning to become pregnant during the two years (24 months) following arthrodesis 4. Subject has an active local or systemic infection. 5. Subject is a prisoner 6. Patient has any condition (including malignancy), that in the opinion of the Investigator, would prohibit the patient from complying with and/or completing the protocol
References
Publications (0)
Data not yet available
No reference posted for this study.