Clinical trial NCT05237908: Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK Cages
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Disk Herniated Lumbar
Disc Disease Degenerative
Spondylolisthesis
Keywords: Transforaminal lumbar interbody fusion
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2022-02-14
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited consecutively. No selection besides the inclusion and exclusion criteria will take place.

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical outcome measured with the Oswestry Disability Index
timeFrame: 1 year postoperatively
Secondary outcomes:
measure: Clinical improvement: pain
timeFrame: preoperatively, at 3 months, 1 year, 2 years and 5 years postoperatively
measure: Development Quality of life (EQ-5D-5L)
timeFrame: preoperatively, at 3 months, 1 year, 2 years and 5 years postoperatively
measure: Radiological outcome: Fusion
timeFrame: 1 year postoperatively
measure: Radiological outcome: Implant subsidence
timeFrame: 1 year postoperatively
measure: Radiological outcome: Implant migration
timeFrame: 1 year postoperatively
measure: Rate of (Serious) adverse events
timeFrame: throughout the studies duration up to five years postoperatively
measure: Development of Clinical outcome measured with the Oswestry Disability Index
timeFrame: preoperatively, at 3 months, 1 year, 2 years and 5 years postoperatively.
Other outcomes:
measure: Duration of surgery
timeFrame: Intraoperative
measure: Blood loss
timeFrame: intraoperative
measure: Length of hospital stay
timeFrame: up to patient's discharge from hospital (approximately 5 days postoperatively)
measure: Development of Patient satisfaction over time
timeFrame: Throughout the postoperative examinations (at each follow-up 3 months, 1 year, 3 years, 5 years postoperative)
measure: Return to work status
timeFrame: Throughout the postoperative examinations (at each follow-up 3 months, 1 year, 3 years, 5 years postoperative)
Locations:
city: Frankfurt
country: Germany
facility: BG Unfallklinik Frankfurt am Main
state: Hessen
Study officials:
References: