Disk Herniated LumbarPRINTLIFNCT05237908
Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK Cages
An observational study of Disk Herniated Lumbar and Disc Disease Degenerative, run by Aesculap AG at 1 site in Germany.
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 Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Disk Herniated Lumbar, Disc Disease Degenerative, Spondylolisthesis
- What is being tested?
- Transforaminal Lumbar Interbody Fusion
- Type of treatment
- Medical device
- How many people
- 78 participants
- Where
- 1 siteGermany
- Study dates
- 18 Feb 2022to Aug 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited consecutively. No selection besides the inclusion and exclusion criteria will take place.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
BG Unfallklinik Frankfurt am Main
Frankfurt am Main, Hesse, 60389
About this study
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
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
Read the 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.
- Being tested
- Transforaminal Lumbar Interbody Fusion
- Keywords
- Transforaminal lumbar interbody fusion
- Medical subject headings
- Intervertebral Disc Degeneration, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transforaminal Lumbar Interbody FusionDevice
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
| Study group | Role | What they receive |
|---|---|---|
| TSPACE 3D | the 3D printed cage (TSPACE 3D) is defined as investigational product Receives: Device: Transforaminal Lumbar Interbody Fusion | |
| TSPACE XP | the titanium coated PEEK cage (TSPACE XP) is defined as reference product. Receives: Device: Transforaminal Lumbar Interbody Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year postoperatively
Secondary outcomes (7)
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"
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: preoperatively, at 3 months, 1 year, 2 years and 5 years postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start18 Feb 2022
- Primary completion22 May 2023
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disk Herniated LumbarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237908
- Sponsor's protocol ID
- AAG-O-H-2114
- Acronym
- PRINTLIF
- Status last verified
- Jun 2026
- First submitted
- 3 Feb 2022
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No