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NCT Number: NCT05237908

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Disk Herniated Lumbar Bone Diseases Disc Disease Degenerative Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases Spondylolisthesis Spondylolysis Spondylosis

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

BG Unfallklinik Frankfurt am Main

Frankfurt am Main, Hesse, 60389, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transforaminal Lumbar Interbody Fusion

Device

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

Primary outcomes

  1. Clinical outcome measured with the Oswestry Disability Index

    Time frame: 1 year postoperatively

    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.

Secondary outcomes

  1. Clinical improvement: pain

    Time frame: preoperatively, at 3 months, 1 year, 2 years and 5 years postoperatively

    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"

  2. Development Quality of life (EQ-5D-5L)

    Time frame: preoperatively, at 3 months, 1 year, 2 years and 5 years postoperatively

    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.

  3. Radiological outcome: Fusion

    Time frame: 1 year postoperatively

    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.

  4. Radiological outcome: Implant subsidence

    Time frame: 1 year postoperatively

    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

  5. Radiological outcome: Implant migration

    Time frame: 1 year postoperatively

    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).

  6. Rate of (Serious) adverse events

    Time frame: throughout the studies duration up to five years postoperatively

    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.

  7. Development of Clinical outcome measured with the Oswestry Disability Index

    Time frame: preoperatively, at 3 months, 1 year, 2 years and 5 years postoperatively.

    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.

Other outcomes

  1. Duration of surgery

    Time frame: Intraoperative

    Duration of the intervention from first cut to suturing

  2. Blood loss

    Time frame: intraoperative

    Amount of Blood loss due to the intervention

  3. Length of hospital stay

    Time frame: up to patient's discharge from hospital (approximately 5 days postoperatively)

    Number of days the patient has to stay in hospital after the intervention

  4. Development of Patient satisfaction over time

    Time frame: Throughout the postoperative examinations (at each follow-up 3 months, 1 year, 3 years, 5 years postoperative)

    The satisfaction of the patient with the spine intervention is evaluated at all postoperative examinations

  5. Return to work status

    Time frame: Throughout the postoperative examinations (at each follow-up 3 months, 1 year, 3 years, 5 years postoperative)

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study 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

Acronym: PRINTLIF

Important dates

Study start
2022
Primary completion
2023
Study completion
2028
First posted
Feb 14, 2022
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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