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

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

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

Study Overview

• Status: Recruiting
• Conditions: Disk Herniated Lumbar; Spondylolisthesis; Disc Disease Degenerative
• Intervention / Treatment: Device: Transforaminal Lumbar Interbody Fusion

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 78

Contacts and Locations

• Study Contact: Name: Stefan Maenz, Dr.; Phone Number: +49746195; Email: stefan.maenz@aesculap.de

Study Locations

• Germany
  • Hessen
    • Frankfurt, Hessen, Germany, 60389
      • Recruiting
      • BG Unfallklinik Frankfurt am Main
      • Contact: Frank Kandziora, Prof. Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients will be recruited consecutively. No selection besides the inclusion and exclusion criteria will take place.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TSPACE 3D; the 3D printed cage (TSPACE 3D) is defined as investigational product	Device: 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
TSPACE XP; the titanium coated PEEK cage (TSPACE XP) is defined as reference product.	Device: 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

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of surgery	Duration of the intervention from first cut to suturing	Intraoperative
Blood loss	Amount of Blood loss due to the intervention	intraoperative
Length of hospital stay	Number of days the patient has to stay in hospital after the intervention	up to patient's discharge from hospital (approximately 5 days postoperatively)
Development of Patient satisfaction over time	The satisfaction of the patient with the spine intervention is evaluated at all postoperative examinations	Throughout the postoperative examinations (at each follow-up 3 months, 1 year, 3 years, 5 years postoperative)
Return to work status		Throughout the postoperative examinations (at each follow-up 3 months, 1 year, 3 years, 5 years postoperative)

Collaborators and Investigators

• Sponsor: Aesculap AG

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2022
• Primary Completion (Estimated): August 1, 2023
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: February 3, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Transforaminal lumbar interbody fusion
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Intervertebral Disc Degeneration; Spondylolisthesis
• Other Study ID Numbers: AAG-O-H-2114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No