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

NCT05237908 | Active Not Recruiting

• 1 other identifier: AAG-O-H-2114
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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

Conditions

Disk Herniated Lumbar; Disc Disease Degenerative; Spondylolisthesis

Keywords

Transforaminal lumbar interbody fusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Clinical improvement: pain

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

• Development Quality of life (EQ-5D-5L)

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

• Radiological outcome: Fusion

  1 year postoperatively

• Radiological outcome: Implant subsidence

  1 year postoperatively

• Radiological outcome: Implant migration

  1 year postoperatively

Other Outcomes (5)

• Duration of surgery

  Intraoperative

• Blood loss

  intraoperative

• Length of hospital stay

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

Study Arms (2)

TSPACE 3D

the 3D printed cage (TSPACE 3D) is defined as investigational product

Device: Transforaminal Lumbar Interbody Fusion

TSPACE XP

the titanium coated PEEK cage (TSPACE XP) is defined as reference product.

Device: Transforaminal Lumbar Interbody Fusion

Interventions

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

TSPACE 3D; TSPACE XP

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will be recruited consecutively. No selection besides the inclusion and exclusion criteria will take place.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aesculap AG: lead

Study Sites (1)

BG Unfallklinik Frankfurt am Main

Frankfurt am Main, Hesse, 60389, Germany

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spondylolisthesis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 14, 2022
• Study Start: February 18, 2022
• Primary Completion: May 22, 2023
• Study Completion (Estimated): August 1, 2028
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)