An observational study in Disk Herniated Lumbar, Disc Disease Degenerative and Spondylolisthesis, sponsored by Aesculap AG. Active, not recruiting at 1 site in Germany. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Aesculap AG · Observational
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
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.
464 studies on the registry are indexed under Intervertebral Disc Degeneration; 98 are open to participants now.
This study's planned enrollment of 78 is below the median of 120 across 166 observational studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →Aesculap AG is the lead sponsor of 104 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients will be recruited consecutively. No selection besides the inclusion and exclusion criteria will take place.
Exclusion Criteria:
the 3D printed cage (TSPACE 3D) is defined as investigational product
Device: Transforaminal Lumbar Interbody Fusion
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
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.
Time frame: 1 year postoperatively
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"
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: preoperatively, at 3 months, 1 year, 2 years and 5 years postoperatively.
Duration of surgery
Duration of the intervention from first cut to suturing
Time frame: Intraoperative
Blood loss
Amount of Blood loss due to the intervention
Time frame: intraoperative
Length of hospital stay
Number of days the patient has to stay in hospital after the intervention
Time frame: 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
Time frame: Throughout the postoperative examinations (at each follow-up 3 months, 1 year, 3 years, 5 years postoperative)
Return to work status
Time frame: Throughout the postoperative examinations (at each follow-up 3 months, 1 year, 3 years, 5 years postoperative)
Plan to share: No
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This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Intervertebral Disc Degeneration→
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