Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06265038
Status:
RECRUITING
Last Update Posted:
2024-02-21
First Post:
2024-02-09
Brief Title:
Confirmatory Investigation to Evaluate the Performance and Safety of ReSpace TiCell Cage Implants in TLIF
Sponsor:
Sanatmetal Orthopaedic and Traumatologic Equipment Manufacturer Ltd
Organization:
Sanatmetal Orthopaedic and Traumatologic Equipment Manufacturer Ltd
Study Overview
Official Title:
A Prospective Single Center Confirmatory Investigation to Evaluate the Performance and Safety of ReSpace TiCell Cage Implants in Transforaminal Lumbar Interbody Fusion
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients back hipbuttock 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
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 patients back hipbuttock 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 fusionanterior to psoas OLIFATP 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None