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

Spondylolisthesis Clinical Trial

— PRINTLIF  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05237908
• Other study ID #: AAG-O-H-2114
• Status: Active, not recruiting
• Start date: February 18, 2022
• Est. completion date: August 2028

Study information

• Verified date: June 2024
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 78
• Est. completion date: August 2028
• Est. primary completion date: May 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Disc Disease Degenerative
• Disk Herniated Lumbar
• Intervertebral Disc Degeneration
• Spondylolisthesis

Intervention

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

Locations

Country	Name	City	State
Germany	BG Unfallklinik Frankfurt am Main	Frankfurt	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of surgery	Duration of the intervention from first cut to suturing	Intraoperative
Other	Blood loss	Amount of Blood loss due to the intervention	intraoperative
Other	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)
Other	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)
Other	Return to work status		Throughout the postoperative examinations (at each follow-up 3 months, 1 year, 3 years, 5 years postoperative)
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.