NCT03565224

Study of Titanium-Coated PEEK Cages for Degenerative Disc Disease

Prospective Follow-up Study of CeSPACE XP - Titanium Coated PEEK Cages - for the Treatment of Degenerative Cervical Disc Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Spinal Fusion
• Cervical Vertebral Fusion

Timeline

• Start date: 2018-01-10
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2018-06-21
• Last updated: 2019-04-30

Locations

1 site across 1 country: Spain