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

Study Overview
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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

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.

Official Title
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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

Conditions
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Disk Herniated Lumbar, Disc Disease Degenerative, Spondylolisthesis

Intervention / Treatment
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* Device: Transforaminal Lumbar Interbody Fusion


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TSPACE 3D<br>the 3D printed cage (TSPACE 3D) is defined as investigational product | Device: Transforaminal Lumbar Interbody Fusion<br>* 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<br>|
| TSPACE XP<br>the titanium coated PEEK cage (TSPACE XP) is defined as reference product. | Device: Transforaminal Lumbar Interbody Fusion<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome measured with the Oswestry Disability Index | The Oswestry Disability Index is designed to measure back-specific disability. The questionnaire is self-administered and has 10 items concerning pain and activities of daily living including personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling. It is a self-administered questionnaire Each section is scored on a 0-5 scale, 5 is for maximum disability. The index is calculated by dividing the total score by the total possible score, which is multiplied by 100 and expressed as a percentage. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible. | 1 year postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement: pain | Pain will be assessed by the patient using the Visual Analogue Scale (VAS) which state 0 at one end representing no pain and 100 at the opposite end representing maximal/worst pain | preoperatively, at 3 months, 1 year, 2 years and 5 years postoperatively | 
| Development Quality of life (EQ-5D-5L) | EQ-5D-5L is a standardized 5-dimension 5-level measure of the health status and is developed by the EuroQol Group in order to have a simple and generic measure for clinical and economic assessment. In order to analyze the quality of life of the patients, the EQ-5D-5L is used. The score is self-completed by the patient and will therefore be used in German. | preoperatively, at 3 months, 1 year, 2 years and 5 years postoperatively | 
| Radiological outcome: Fusion | Bone fusion: After interbody fusion surgery fusion of the treated segment is aspired. Thus, the implant design shall allow on-/ingrowth to/into the material. The fusion status can be determined from radiographs (static or dynamic). Bony fusion can be characterized quantitatively by the fusion rate. | 1 year postoperatively | 
| Radiological outcome: Implant subsidence | Implant penetration into the vertebral body occurs frequently after spinal reconstruction. Interbody fusion cages may subside into the vertebral body and lead to kyphotic deformity | 1 year postoperatively | 
| Radiological outcome: Implant migration | Interbody fusion cages might migrate forward into the retroperitoneum or backwards into the vertebral canal and can, thus, cause serious clinical consequences (e.g. compression of nerve roots or dura mater). | 1 year postoperatively | 
| Rate of (Serious) adverse events | Occurrence of complications potentially associated with the implanted devices can never be fully excluded during spinal surgery. In order to monitor potential complication and to identify so far unknown complications adverse events (AE) and serious adverse events (SAE) deemed related to the investigational device are recorded. | throughout the studies duration up to five years postoperatively | 
| Development of Clinical outcome measured with the Oswestry Disability Index | The Oswestry Disability Index is designed to measure back-specific disability. The questionnaire is self-administered and has 10 items concerning pain and activities of daily living including personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling. It is a self-administered questionnaire Each section is scored on a 0-5 scale, 5 is for maximum disability. The index is calculated by dividing the total score by the total possible score, which is multiplied by 100 and expressed as a percentage. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible. | preoperatively, at 3 months, 1 year, 2 years and 5 years postoperatively. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transforaminal lumbar interbody fusion