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Exploratory Study of 3D Printed Biodegradable Cervical Interbody Fusion Cage

Sponsor
Xijing Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04167878
Collaborator
(none)
10
Enrollment
2
Arms
13
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

A small sample, single center, non-randomized, noninferiority clinical trial to evaluate the safety and effectiveness of 3D printed biodegradable cervical interbody fusion cage in anterior cervical discectomy and fusion (ACDF) for treating patients with a symptomatic degenerative cervical disc disease at one level from C2/C4 to C7/T1.

Condition or Disease Intervention/Treatment Phase
  • Device: 3D printed biodegradable cervical fusion cage
  • Device: PEEK cage
 N/A

Detailed Description

The study will evaluate if 3D printed biodegradable cervical interbody fusion cage is non-inferior to poly-ether-ether-ketone (PEEK) cage in single-level ACDF with the use of local autologous bone. 3D printed biodegradable cervical interbody fusion cage is a restorable cervical interbody cage for the treatment of fusion, following discectomy, of the cervical spine from C2/C4 disc space to the C7/T1 disc space. The material used to prepare the implant is a mixture of polycaprolactone (PCL) and tricalcium phosphate (TCP), which is called PCL-TCP. The implant has proper strength and connective porosity. The PCL-TCP cage is intended to be used with a supplemental fixation system.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A total of 5 couple， 10 patients will be assigned into investigational (n=5) and control groups (n=5).A total of 5 couple， 10 patients will be assigned into investigational (n=5) and control groups (n=5).
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
3D Printed Biodegradable Cervical Interbody Fusion Cage in Anterior Cervical Discectomy and Fusion，a Small Sample and Exploratory Research
Anticipated Study Start Date :
Dec 1, 2019
Anticipated Primary Completion Date :
Dec 30, 2020
Anticipated Study Completion Date :
Dec 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: ACDF with 3D printed biodegradable cervical fusion cage

A resorbable cervical interbody cage made of PCL-TCP.

Device: 3D printed biodegradable cervical fusion cage
ACDF with 3D printed biodegradable cervical interbody fusion cage for spinal fusion procedure at one level (C2 to T1) of the cervical spine.
Other Names:
  • 3D printed PCL-TCP cage

    		•
    Active Comparator: ACDF with PEEK cage

    A structural PEEK cage with autologous bone.

    Device: PEEK cage
    ACDF with PEEK cage for spinal fusion procedure at one level (C2 to T1) of the cervical spine.

    Outcome Measures

    Primary Outcome Measures

    1. Radiologic evaluation [12 months]

      Radiologic fusion assessed by roentgenographic examination or CT scan

    Secondary Outcome Measures

    1. Japanese Orthopaedic Association Scores (JOA scores) [12 months]

      The whole name is Japanese Orthopaedic Association Scores for Assessment of Cervical spondylosis, the range of JOA is 0-17 and the full score is 17 to represent a normal function.

    2. Measurement of Pain: Visual Analog Scale (VAS) [12 months]

      The whole name is Visual Analog Scale which is ranged from 0-10, with 0 being the least and 10 being the worst pain experienced.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Skeletally mature patients aged between 25 and 85 years (inclusive);

    2. Symptomatic cervical disc disease (SCDD) in the vertebral level between C2/C3 to C7/T1, correlated with radiculopathy or myelopathy;

    3. Radiographic confirmation (by CT, MRI, x-ray, etc.) of any of the following: herniated nucleus pulposus, spondylosis or loss of disc height;

    4. Requires only one cervical vertebral level to be surgically treated;

    5. Failed at least 12 weeks of conservative treatment;

    6. Patient must understand and sign the Informed Consent document that has been approved by the Ethics committee;

    7. No significant restrictions showed by the pre-surgical routine test and examination.

    Exclusion Criteria:

    1. Skeletally immature patients;

    2. Prior radiation history at anterior cervical area;

    3. Prior surgery at the level to be treated;

    4. More than one vertebral level requiring treatment, confirmed radiologically by X-ray, CT, or MRI

    5. Complication of ossification of the ligamentum flavum, and Ossification of the posterior longitudinal ligament;

    6. Clinically compromised vertebral bodies at the affected level(s) due to trauma or tuberculosis

    7. Severe osteoporosis;

    8. Active systemic or local infection;

    9. Participation in other investigational device or drug clinical trials within 3 months of surgery;

    10. Other patients whom the investigator believe not appropriate.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Xijing Hospital

    Investigators

    • Principal Investigator: Zheng Guo, doctor, Department of orthopedics， Xijing Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xijing Hospital
    ClinicalTrials.gov Identifier:
    NCT04167878
    Other Study ID Numbers:
    • KY20192002-F-2
    First Posted:
    Nov 19, 2019
    Last Update Posted:
    Nov 29, 2019
    Last Verified:
    Mar 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 29, 2019