Spinal Fusion Clinical Trial
Official title:
The OsteoStrand Plus Deformity Study
Verified date | March 2023 |
Source | SeaSpine, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A clinical study evaluating outcomes for patients with spinal deformity.
Status | Active, not recruiting |
Enrollment | 28 |
Est. completion date | June 30, 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: -=18 years of age - Indicated for deformity correction surgery - Require spinal fusion at four or more levels - Are willing to return for follow-up visits - Willing to sign the Informed Consent Forms Exclusion Criteria: - Uncontrolled diabetes - Morbid obesity - history of alcohol or drug abuse - Corticosteroid use - Fever or leukocytosis - Systemic infection - Active malignancy - Elevation of white blood cell count - Osteoporosis - Disease of bone metabolism - Unsuitable or insufficient bone support - Skeletal immaturity - Prior fusion - Use of steroids, immune suppressants, osteoporosis medications - Use of internal bone stimulators - Institutionalized or a prisoner - Undergoing (Undergone) a worker's compensation case - Pregnancy (includes women who are currently pregnant, lactating or wishing to become pregnant during the study duration) - Participation in another research study involving another implant, product or drug that may affect the outcomes of this clinical study within the last 30 days, or planned during this clinical study - Any other condition that the Investigator determines is unacceptable for enrollment into this clinical study |
Country | Name | City | State |
---|---|---|---|
United States | Sonoran Spine | Tempe | Arizona |
Lead Sponsor | Collaborator |
---|---|
SeaSpine, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of fusion for the demineralized bone matrix cohort vs bone morphogenic protein cohort | Proportion of spinal levels in the demineralized bone matrix cohort vs bone morphogenic protein cohort achieving fusion. | 12 Months | |
Secondary | Clinical outcomes | Oswestry Disability Index (ODI) | 24 Months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04037059 -
Impact of Body Habitus (Arm Span and Abdominal Girth) on Activities of Daily Living (ADL)
|
||
Recruiting |
NCT03883022 -
Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery
|
N/A | |
Not yet recruiting |
NCT06003010 -
Yoga for Adolescent Idiopathic Scoliosis (AIS) Patients
|
N/A | |
Completed |
NCT01136590 -
Multicenter, Randomized Placebo-controlled Clinical Trial to Evaluate the Effect of Perioperative Use of Tranexamic Acid on Transfusion Requirements and Surgical Bleeding in Major Spine Surgery
|
Phase 4 | |
Completed |
NCT01235650 -
Prevalence of Inadvertent Hyperventilation During Intraoperative Anesthetic Care
|
N/A | |
Completed |
NCT03459404 -
Sufentanil NanoTab PCA System/15 mcg for Acute Post-Operative Pain in Vertebral Surgery: A Preliminary Investigation
|
||
Recruiting |
NCT05010148 -
A Clinical Trial of Intravenous Lidocaine After Spinal Surgery to Prevent Delirium and Reduce Pain
|
Phase 3 | |
Recruiting |
NCT04605120 -
Allogeinic Bone Paste
|
N/A | |
Completed |
NCT03826329 -
Risk Factors of Second Surgery for Adjacent Segment Disease Following Anterior Cervical Discectomy and Fusion
|
||
Recruiting |
NCT04601363 -
Personalized Spine Study Group (PSSG) Registry
|
||
Recruiting |
NCT05323448 -
Efficacy of ARISTA-AH for Restoring Hemostasis Following Posterior Long-segment Spinal Fusion.
|
N/A | |
Completed |
NCT00994656 -
Is Pleth Variability Index (PVI) a Surrogate for Pulse Pressure Variations (PPV) in Pediatric Spine Fusion (SF) Surgery?
|
N/A | |
Completed |
NCT00152152 -
Use of Radiostereometric Analysis Beads (RSA) to Measure Motion in the Spine, Following Lumbar Spinal Surgery
|
N/A | |
Terminated |
NCT03425799 -
Efficacy and Safety of Tranexamic Acid in Spinal Fusion Surgery
|
Phase 3 | |
Not yet recruiting |
NCT06368245 -
Durability of Suppl. Rod Constructs-SuppleMentAry Rod Technique for Long-segment Posterior Instrumented Spinal Fusions
|
||
Withdrawn |
NCT03908203 -
Minimally Invasive Surgery Techniques for One-level Degenerative Lumbar Deformities Correction
|
N/A | |
Terminated |
NCT03378973 -
The Effects of Dexmedetomidine Dose on Motor Evoked Potentials
|
Phase 4 | |
Completed |
NCT05936047 -
Bone Marrow Clot for Posterior Lumbar Fusion
|
N/A | |
Not yet recruiting |
NCT03692845 -
Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion
|
N/A | |
Completed |
NCT00152165 -
Use of Radiostereometric Analysis (RSA) Following Spinal Fusion Versus the DYNESYS Stabilization System
|
N/A |