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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05237908
Other study ID # AAG-O-H-2114
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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.
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