NCT06265038

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: Sanatmetal Orthopaedic and Traumatologic Equipment Manufacturer Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Degenerative disc and facet joint disease of the lumbar spine is common in the ageing population and is one of the most frequent causes of disability. Lumbar spondylosis may result in mechanical back pain, radicular and claudicant symptoms, reduced mobility and poor quality of life. Surgical interbody fusion of degenerative levels is an effective treatment option to stabilize the painful motion segment, and may provide indirect decompression of the neural elements, restore lordosis and correct deformity. Lumbar interbody fusion (LIF) involves placement of an implant (cage, spacer or structural graft) within the intervertebral space after discectomy and endplate preparation. At this time LIF is performed using five main approaches; posterior lumbar interbody fusion (PLIF), transforaminal lumbar interbody fusion (TLIF), oblique lumbar interbody fusion/anterior to psoas (OLIF/ATP), anterior lumbar interbody fusion (ALIF) and lateral lumbar interbody fusion (LLIF). There is no clear definitive evidence for one approach being superior to another in terms of fusion or clinical outcomes. These operations can also be performed using mini-open or minimally invasive (MIS) approaches, however it has not yet been demonstrated that MIS-TLIF is clinically superior to traditional open TLIF procedure. Interbody fusion is preferable to postero-lateral 'onlay' fusion techniques due to lower rates of postoperative complications and pseudoarthrosis. Posterior interbody fusion (PLIF), combined with segmental instrumentation, has become increasingly popular since it was first described by Mercer in 1936 and expanded upon by Cloward. More recently however, the transforaminal approach to the intervertebral disc, known as transforaminal lumbar interbody fusion (TLIF), has gained popularity. Originally described by Harms in the late 1990s, the TLIF has arguably developed into the most commonly performed and efficacious posterior interbody fusion method in modern spine surgery. Transforaminal lumbar interbody fusion (TLIF) utilizes a more lateral window in order to access the interbody space without excessive dural retraction. Theoretical advantages of TLIF include increased fusion success, more complete foraminal decompression, better correction of deformity, and more effective treatment of discogenic pain. Transforaminal lumbar interbody fusion (TLIF) have demonstrated excellent fusion rates with acceptable complication profiles for treating single and multilevel lumbar disc pathology and instability. TLIF have been shown to be superior to posterolateral fusion alone for deformity correction and more cost effective than anterior interbody combined with posterior segmental instrumentation.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-02-01
• Primary completion: 2026-02-01
• Completion: 2026-10-01
• First posted: 2024-02-20
• Last updated: 2024-02-21

Locations

1 site across 1 country: Hungary