Clinical trial NCT03565224: Study of Titanium-Coated PEEK Cages for Degenerative Disc Disease
Official title: Prospective Follow-up Study of CeSPACE XP - Titanium Coated PEEK Cages - for the Treatment of Degenerative Cervical Disc Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Fusion
Cervical Vertebral Fusion
Keywords: Cervical vertebrae
Postoperative complications
Radiography
Spinal fusion
Coating
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2018-06-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients

Brief 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Pregnancy
* Patient consent not signed

Primary outcomes:
measure: Neck Disability Index (NDI) during Follow-Up
timeFrame: Once between 1 to 4 years postoperative
Secondary outcomes:
measure: Patient Satisfaction at Follow-Up
timeFrame: Once between 1 to 4 years postoperative
measure: Neck Pain at Follow-Up
timeFrame: Once between 1 to 4 years postoperative
measure: Arm Pain during Follow-Up
timeFrame: Once between 1 to 4 years postoperative
measure: Neurological Outcome at Follow-Up
timeFrame: 1 to 4 years follow-up
measure: Work Status at Follow-Up
timeFrame: Once between 1 to 4 years postoperative
measure: Radiographic Evaluation of Mobility at Follow-Up
timeFrame: Once between 1 to 4 years postoperative
measure: Radiographic Evaluation of Bone Bridges at Follow-Up
timeFrame: Once between 1 to 4 years postoperative
measure: Radiographic Evaluation of Radiolucencies at Follow-Up
timeFrame: Once between 1 to 4 years postoperative
Other outcomes:
measure: Rate of Patients with Adverse Events and Serious Adverse Events during Follow-up
timeFrame: Up to 4 years postoperative
Locations:
city: Zaragoza
country: Spain
facility: Hospital MAZ Zaragoza
Study officials:
affiliation: Hospital MAZ Zaragoza
name: Ricardo Arregui, Dr., MD
role: PRINCIPAL_INVESTIGATOR
References: