N/A
N=69
Anterior Bridging Cage With Bone Substitute Versus Localized Autobone in Transforaminal Lumbar Interbody Arthrodesis
Stenosis · Fusion of Spine (Disease)
Bottom Line
View on ClinicalTrials.gov: NCT02485574 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: InCBB of Both Cages — 1.48; 1.43 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- transforaminal lumbar interbody arthrodesis (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zenoss Co, Ltd
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY InCBB of Both Cages |
1.48; 1.43 | — |
| SECONDARY ABB (Anterior Bone Bridging) Between Cage and Anterior Grafted Bone |
1.80; 1.85 | — |
Summary
The purpose of this study is to evaluation for the pattern of bone bridging of patients who undergo transforaminal lumbar interbody arthrodesis, the investigators hypothesize that auto local bone mixed with β-calcium phosphate + hydroxyapatite (OSTEON 2, Genoss) is not inferior to auto local bone only. In addition, the investigators will analyze anterior new bone bridging pattern between anterior bridging cage newly developed and grafted bone in anterior disc space.
Eligibility Criteria
Inclusion Criteria
- Patients who need lumbar interbody fusion in Degenerative spine disease on L1-S1(Spinal stenosis, HIVD and internal derangement of disk, spine instability)
- Patients who have no communication problems
- Patients who are willing to visit the hospital for any follow-up assessment
- Patients who voluntarily sign on a written consent
Exclusion Criteria
- Patients who have infection
- Patients who have bleeding disorders
- Patients who have immunosuppressed disease
- Patients who can't sign on consent form
- Patients who are in pregnancy or breast feeding
- Patients who have severe osteoporosis
- Patients who can't take general surgery because of severe liver disease or decreased renal function
- Patients who have acute spinal injury, spinal tumor or inflammatory spinal disease
Data sourced from ClinicalTrials.gov (NCT02485574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.