MedTrace Logo

Confirmatory Investigation to Evaluate the Performance and Safety of ReSpace TiCell Cage Implants in TLIF

NCT06265038 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2024-02-21

No results posted yet for this study

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.

Conditions

  • Degenerative Instability
  • Spondylolisthesis
  • Post-discectomy Syndrome
  • Post-traumatic Instability

Interventions

DEVICE

ReSpace TiCell Cage

ReSpace TiCell Cages are anatomically shaped interbody spacer implants with curved contour. These implants intended to be inserted into the intervertebral disc space for intervertebral body fusion. The interbody spacers are designed to restore height and lordotic angle in the spine. The spacers have teeth on the endplate-engaging surfaces to provide stability, resist shear and rotational forces, and to help prevent migration of the spacer within the disc space. The open central cavity on them allows for placement of graft material allowing for subsequent bone growth through the interior of the devices. ReSpace TiCell Cages are indicated for lumbar spine stabilization (between L.I.-S.I. segments). TLIF spine surgery will be combined with posterior fixation using pedicle screws and rods.

Sponsors & Collaborators

  • Sanatmetal Orthopaedic and Traumatologic Equipment Manufacturer Ltd.

    lead INDUSTRY

Principal Investigators

  • Aron Lazary, MD, PhD · National Center for Spinal Disorders

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2026-02-01
Completion
2026-10-01

Countries

  • Hungary

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06265038 on ClinicalTrials.gov