Actively Recruiting
Confirmatory Investigation to Evaluate the Performance and Safety of ReSpace TiCell Cage Implants in TLIF
Led by Sanatmetal Orthopaedic and Traumatologic Equipment Manufacturer Ltd. · Updated on 2024-02-21
99
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to confirm superiority for the efficacy of the ReSpace Ticell Cage implants in Transforaminal Lumbar Interbody Fusion compared to state-of-the-art. The secondary objective of the study is to evaluate further efficacy and safety of the ReSpace Ticell Cage implants in Transforaminal Lumbar Interbody Fusion with the following secondary efficacy and safety objectives: * To evaluate if implantation causes significant reduction in patient's back, hip/buttock, and leg pain. * To evaluate if implantation causes significant increase quality of life of the patients. * To evaluate if using the device can be considered as safe overall.
CONDITIONS
Official Title
Confirmatory Investigation to Evaluate the Performance and Safety of ReSpace TiCell Cage Implants in TLIF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Previously indicated for TLIF surgery for degenerative lumbosacral spine disease in one or two adjacent levels (L1 to S1)
- Symptoms include low back pain, radiating leg or buttock pain, paresthesia, numbness, weakness, or neurogenic claudication
- Radiographic evidence of degenerative disease such as instability, decreased disc height, ligament thickening, herniated nucleus pulposus, vacuum phenomenon, Grade 1 spondylolisthesis/retrolisthesis, stenosis requiring decompression, or recurrent disc herniation
- Able to read and understand study documents and patient-reported outcome questionnaires
You will not qualify if you...
- Prior surgical procedures at involved or adjacent spinal levels except microdiscectomy, discectomy, laminectomy, or decompression
- Significant lumbar instability with sagittal listhesis greater than Grade 2 or lateral listhesis greater than 3 mm
- Planned use of internal or external bone growth stimulator
- Lumbar scoliosis greater than 30 degrees
- Diagnosis of osteoporosis with T-score -2.5 or below in the last 12 months without recent DEXA if fragility fracture present
- Morbid obesity with BMI over 40
- Active or prior malignancy excluding certain skin cancers
- Active bacterial infection local or systemic
- Use of bone or soft tissue healing-inhibiting medications within 30 days prior to implantation
- Co-morbidities precluding surgery
- Autoimmune diseases affecting bone metabolism or spine
- Endocrine or metabolic disorders affecting bone growth
- Known allergies to study treatment components or materials
- History of anaphylaxis
- Mental incompetence
- Use of investigational therapies for spinal conditions within 3 months prior or planned during 24-month follow-up
- Pregnancy or breastfeeding
- Substance use disorder excluding nicotine
- Conditions interfering with study compliance
- Vulnerable population status
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Center for Spinal Disorders
Budapest, Pest County, Hungary, 1126
Actively Recruiting
Research Team
B
Bálint Kozma
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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