A Prospective, Single Center, Confirmatory Investigation to Evaluate the Performance and Safety of ReSpace TiCell Cage Implants in Transforaminal Lumbar Interbody Fusion

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Each subject must meet all the following criteria to be enrolled in this study:

• All subjects who had previously indicated for TLIF surgery can participate in this study, with the following evidence:

⁃ Has degenerative disease of the lumbosacral spine in one or two adjacent levels (L1 to S1), manifested by:

∙ Low back pain, or

‣ Irradiating leg or buttock pain, paresthesia, numbness, or weakness, or

‣ History of neurogenic claudication.

⁃ Has radiographic evidence (e.g. CT, MRI, x-ray, etc.) of degenerative lumbosacral disease including at least one of the following:

∙ Instability as defined by ≥3 mm translation or ≥5-degree angulation

‣ Decreased disc height, on average by ≥2 mm, but dependent upon the spinal level

‣ Scarring/thickening of ligamentum flavum or annulus fibrosis

‣ Herniated nucleus pulposus

‣ Vacuum phenomenon

‣ Grade 1 spondylolisthesis/retrolisthesis based on the Meyerding classification (Meyerding, Henry William, 1932), or lateral listhesis demonstrated by coronal plane translation (slippage) of the superior (cranial) vertebral body lateral to the inferior (caudal) vertebral body less than or equal to 3mm, or

‣ Stenosis, or narrowing, of the lumbar spinal canal and/or intervertebral foramen requiring significant decompression leading to segmental instability, or

‣ Recurrent disc herniation

• Further inclusion criteria:

• Skeletally mature adults ages 18 - 80 years of age

• Able to read and understand all documents used in this study, including the informed consent and patient-reported outcome questionnaires

Locations
Other Locations
Hungary
National Center for Spinal Disorders
RECRUITING
Budapest
Contact Information
Primary
Bálint Kozma
bkozma@sanatmetal.hu
+3630 6861784
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 99
Treatments
Other: Prospective, single-arm, open-label clinical trial.
Single center, prospective cohort, single-arm, open-label clinical trial Standard-of-care \& Sanatmetal ReSpace TiCell Cage implantation A single-center study is sufficient to provide confirmatory data on performance and safety of the investigational device.
Related Therapeutic Areas
Sponsors
Leads: Sanatmetal Orthopaedic and Traumatologic Equipment Manufacturer Ltd.

This content was sourced from clinicaltrials.gov

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