Exploratory Study of 3D Printed Biodegradable Cervical Interbody Fusion Cage

Air Force Military Medical University of People's Liberation Army

Status: Active, not recruiting

Conditions: Symptomatic Cervical Disc Disease

Treatments: Device: 3D printed biodegradable cervical fusion cage; Device: PEEK cage

Study type: Interventional

Funder types: Other

Identifiers

NCT04167878

KY20192002-F-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 25 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

ACDF with 3D printed biodegradable cervical fusion cage

Experimental group

Description:

A resorbable cervical interbody cage made of PCL-TCP.

Treatment:

Device: 3D printed biodegradable cervical fusion cage

ACDF with PEEK cage

Active Comparator group

Description:

A structural PEEK cage with autologous bone.

Treatment:

Device: PEEK cage