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

NARecruitingINTERVENTIONAL
Enrollment

99

Participants

Timeline

Start Date

February 1, 2024

Primary Completion Date

February 1, 2026

Study Completion Date

October 1, 2026

Conditions
Degenerative InstabilitySpondylolisthesisPost-discectomy SyndromePost-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."

Trial Locations (1)

1126

RECRUITING

National Center for Spinal Disorders, Budapest

All Listed Sponsors
lead

Sanatmetal Orthopaedic and Traumatologic Equipment Manufacturer Ltd.

INDUSTRY