Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK Cages

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-18

Study Completion Date

2028-08-31

Brief Summary

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Prospective, Randomized, Single-Blind Study for the Evaluation of the Clinical Outcome and the Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK Cages in Transforaminal Lumbar Interbody Fusion

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Detailed Description

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This clinical study is a regulatory Post Market Clinical Follow-Up (PMCF) measure and is aiming to collect clinical data on the performance and safety of the TSPACE® 3D implants. It is designed as a prospective, randomized, single-blind, non-interventional study in order to gain clinical data within the routine clinical application of the investigational device.

The study shall answer the question if there are detectable differences between the established titanium coated Polyether Ether Ketone (PEEK) cages of the manufacturer and the new 3D printed cages. Differences shall be observed in terms of clinical outcome, quality of life, patient satisfaction, radiological outcome and occurrence of Adverse Events / Serious Adverse Events.

Conditions

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Disk Herniated Lumbar Disc Disease Degenerative Spondylolisthesis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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TSPACE 3D

the 3D printed cage (TSPACE 3D) is defined as investigational product

Transforaminal Lumbar Interbody Fusion

Intervention Type DEVICE

Interbody Fusion means the operative immobilization or ankylosis of two or more vertebrae by fusion of the vertebral bodies with a short bone graft or often with diskectomy or laminectomy. (From Blauvelt and Nelson, A Manual of Orthopaedic Terminology, 5th ed, p236; Dorland, 28th ed

TSPACE XP

the titanium coated PEEK cage (TSPACE XP) is defined as reference product.

Transforaminal Lumbar Interbody Fusion

Intervention Type DEVICE

Interbody Fusion means the operative immobilization or ankylosis of two or more vertebrae by fusion of the vertebral bodies with a short bone graft or often with diskectomy or laminectomy. (From Blauvelt and Nelson, A Manual of Orthopaedic Terminology, 5th ed, p236; Dorland, 28th ed

Interventions

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Transforaminal Lumbar Interbody Fusion

Interbody Fusion means the operative immobilization or ankylosis of two or more vertebrae by fusion of the vertebral bodies with a short bone graft or often with diskectomy or laminectomy. (From Blauvelt and Nelson, A Manual of Orthopaedic Terminology, 5th ed, p236; Dorland, 28th ed

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Indication for one, two or three-segment lumbar interbody fusion according to Instructions for use
* Written informed consent for the documentation of clinical and radiological results
* Willingness and mental ability to participate at the follow-up examinations

Exclusion Criteria

* Patient is not willing or able to participate at the follow-up examination
* Patient age \< 18 years and \>80 years
* Patient is pregnant
* Previous instrumented lumbar spine surgery

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No