Radiographic and Clinical Outcomes of Anterior and Transforaminal Lumbar Interbody Fusions: A Systematic Review and Meta-analysis of Comparative Studies.
Remi M Ajiboye, Haddy Alas, Gina M Mosich...
https://pubmed.ncbi.nlm.nih.gov/28622187Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06265038
A Prospective, Single Center, Confirmatory Investigation to Evaluate the Performance and Safety of ReSpace TiCell Cage Implants in Transforaminal Lumbar Interbody Fusion
Led by Sanatmetal Orthopaedic and Traumatologic Equipment Manufacturer Ltd. · Updated on 2024-02-21
99
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the performance and safety of ReSpace TiCell Cage implants used in Transforaminal Lumbar Interbody Fusion (TLIF) surgery. This study aims to confirm if these implants provide better results than current standard treatments for patients with degenerative lumbar spine conditions causing pain and reduced mobility. It also looks at whether the implants reduce back, hip, and leg pain, improve quality of life, and maintain overall safety. The study involves a single group of adult participants undergoing TLIF surgery with the ReSpace TiCell Cage implant combined with posterior fixation using pedicle screws and rods. The implant is designed to stabilize and restore the spine's height and curve, helping bone grow through the device. This single-center, open-label trial will follow participants for up to 24 months to assess outcomes. Participants will be monitored through regular visits at 3, 6, 12, and 24 months after surgery. Assessments include CT imaging to check spinal fusion, pain measurement using a visual analog scale, and disability evaluation with the Oswestry Disability Index. The study tracks safety and effectiveness throughout this period to understand how well the implant supports spine healing and improves patient well-being.
CONDITIONS
Brief Title
Confirmatory Investigation to Evaluate the Performance and Safety of ReSpace TiCell Cage Implants in TLIF
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Diagnosed with degenerative disease of the lumbosacral spine at one or two adjacent levels (L1 to S1)
- Symptoms include low back pain, radiating leg or buttock pain, numbness, weakness, or history of neurogenic claudication
- Radiographic evidence of degenerative lumbosacral disease including instability, decreased disc height, ligament thickening, herniated nucleus pulposus, vacuum phenomenon, Grade 1 spondylolisthesis/retrolisthesis, spinal stenosis, or recurrent disc herniation
- Able to read and understand study documents and questionnaires
- Previously indicated for TLIF surgery
You will not qualify if you...
- Prior fusion or stabilization surgery at involved or adjacent spinal levels (microdiscectomy, discectomy, laminectomy allowed)
- Lumbar instability greater than Grade 2 sagittal listhesis or lateral listhesis over 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 last 12 months without recent DEXA scan if fragility fracture present
- Body Mass Index over 40 (morbid obesity)
- Active or prior malignancy excluding certain skin cancers
- Active bacterial infection
- Recent use (within 30 days) of medications that impair bone or soft tissue healing
- Co-morbidities or autoimmune/endocrine disorders affecting bone metabolism
- Known allergies to study treatment components or history of anaphylaxis
- Mental incompetence or psychiatric conditions affecting consent
- Participation in other investigational therapies for spinal conditions recently or planned during study
- Pregnancy or breastfeeding
- Substance use disorder (except nicotine)
- Any condition affecting ability to comply with study instructions
- Belonging to a vulnerable population
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - 1 day or hospital stay duration
Participants undergo transforaminal lumbar interbody fusion (TLIF) surgery with implantation of the ReSpace TiCell Cage device along with posterior fixation using pedicle screws and rods, followed by immediate post-operative care.
1 surgical visit and immediate post-operative care
Post-operative Follow-up
Duration - 24 months
Participants are monitored after surgery to assess recovery, pain, disability, and fusion status through clinical assessments and imaging.
4 visits at Months 3, 6, 12, and 24
Trial Site Locations
Total: 1 location
1
National Center for Spinal Disorders
Budapest, Pest County, Hungary, 1126
Actively Recruiting
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Research Team
B
Bálint Kozma
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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Published Research Related To This Trial
Mini-transforaminal lumbar interbody fusion versus anterior lumbar interbody fusion augmented by percutaneous pedicle screw fixation: a comparison of surgical outcomes in adult low-grade isthmic spondylolisthesis.
Jin-Sung Kim, Byung-Uk Kang, Sang-Ho Lee...
https://pubmed.ncbi.nlm.nih.gov/19342933Which lumbar interbody fusion technique is better in terms of level for the treatment of unstable isthmic spondylolisthesis?
Jin-Sung Kim, Kil-Yong Lee, Sang-Ho Lee...
https://pubmed.ncbi.nlm.nih.gov/20121352Transforaminal lumbar interbody fusion versus anterior lumbar interbody fusion as an adjunct to posterior instrumented correction of degenerative lumbar scoliosis: three year clinical and radiographic outcomes.
Dennis G Crandall, Jan Revella
https://pubmed.ncbi.nlm.nih.gov/19752698Transforaminal versus anterior lumbar interbody fusion in long deformity constructs: a matched cohort analysis.
Ian G Dorward, Lawrence G Lenke, Keith H Bridwell...
https://pubmed.ncbi.nlm.nih.gov/23442780Clinical and radiological outcome of anterior-posterior fusion versus transforaminal lumbar interbody fusion for symptomatic disc degeneration: a retrospective comparative study of 133 patients.
Antonio A Faundez, James D Schwender, Yair Safriel...
https://pubmed.ncbi.nlm.nih.gov/19125304Anterior/posterior lumbar fusion versus transforaminal lumbar interbody fusion: analysis of complications and predictive factors.
H T Hee, F P Castro, M E Majd...
https://pubmed.ncbi.nlm.nih.gov/11723406Posterolateral fusion (PLF) versus transforaminal lumbar interbody fusion (TLIF) for spondylolisthesis: a systematic review and meta-analysis.
Jay M Levin, Joseph E Tanenbaum, Michael P Steinmetz...
https://pubmed.ncbi.nlm.nih.gov/29452283Modeled cost-effectiveness of transforaminal lumbar interbody fusion compared with posterolateral fusion for spondylolisthesis using N(2)QOD data.
Leah Y Carreon, Steven D Glassman, Zoher Ghogawala...
https://pubmed.ncbi.nlm.nih.gov/26895529Does Transforaminal Lumbar Interbody Fusion Have Advantages over Posterolateral Lumbar Fusion for Degenerative Spondylolisthesis?
Takahito Fujimori, Hai Le, William W Schairer...
https://pubmed.ncbi.nlm.nih.gov/25844282