Study of Titanium-Coated PEEK Cages for Degenerative Disc Disease

Aesculap

Status: Completed

Conditions: Cervical Vertebral Fusion; Spinal Fusion

Study type: Observational

Funder types: Industry

Identifiers

NCT03565224

AAG-O-H-1702

Details and patient eligibility

About

Prospective Follow-up study of CeSPACE XP coated PEEK cages for the treatment of degenerative cervical disc disease

Full description

Anterior cervical discectomy and fusion (ACDF) has been accepted as the standard procedure for the treatment of myelopathy and radiculopathy in the cervical spine. A tricortical iliac crest bone graft is the traditional inter-body fusion material that can show perfect bony fusion and maintain the patency of the neuroforamen. However, donor site complications were reported in fusion with an iliac bone graft, such as subcutaneous hematomas, infections, and chronic wound pain.

Currently, the titanium cage and polyetheretherketone (PEEK) cage are the two most common cages in clinical practice. The ideal cage should lead to a high fusion rate and prevent complications, such as subsidence and loss of correction.

Even though a titanium cage can provide long-term stabilization, increase lordosis, and increase foramina height compared with the iliac bone graft, some inferior clinical outcomes appeared in clinical practice. Loss of correction is a major complication of subsidence that may eventually affect cervical spinal function after the operation.

A modulus of elasticity close to cortical bone might contribute to advantages in stress distribution and load sharing, which can contribute to a lower subsidence rate and, thus, better clinical results, making PEEK cages more welcomed by surgeons.

It is supposed, that in the cervical fusion procedure, a porous coating of a PEEK cage will lead to favourable results. Therefore, the present study intends to show these results, in a larger patient cohort who received such a coated cervical cage.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All consecutive patients who received a CeSPACE XP cage between August 2013 and January 2017

Exclusion criteria

• Pregnancy
• Patient consent not signed

Trial design

50 participants in 1 patient group

Cespace

Description:

The patients have been operated with Cespace Titanium Coated PEEK Cage for Degenerative Disc Disease between 2014 and 2017. All patients are invited to the Hospital for Follow-Up. Depending on the date of Initial Intervention the timeframe of follow-up for the individual Patient is 1 to 4 years.