Study of Titanium-Coated PEEK Cages for Degenerative Disc Disease

Completed

• Conditions: Spinal Fusion; Cervical Vertebral Fusion

• Registration Number: NCT03565224
• Lead Sponsor: Aesculap AG

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.

Study Timeline

• Study Start: 2018-01-10
• Study First Submitted: 2018-05-25
• Study First Submitted QC: 2018-06-11
• Study First Posted: 2018-06-21
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-29
• Last Update Posted: 2019-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• Pregnancy
• Patient consent not signed

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neck Disability Index (NDI) during Follow-Up	Once between 1 to 4 years postoperative	The Neck Disability Index(NDI) is a modification of the Oswestry Low Back Pain Disability Index . It is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. The NDI has sufficient support and usefulness to retain its current status as the most commonly used self-report measure for neck pain. The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. All the points can be summed to a total score.

Secondary Outcome Measures

Name	Time	Method
Neck Pain at Follow-Up	Once between 1 to 4 years postoperative	Patient self-reported Neck Pain measured by Visual Analogue Scale (VAS). The VAS is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.
Patient Satisfaction at Follow-Up	Once between 1 to 4 years postoperative	Patient self-reported satisfaction measured by a four-level scale: excellent, good, not satisfied, bad
Arm Pain during Follow-Up	Once between 1 to 4 years postoperative	Patient self-reported Arm Pain measured by Visual Analogue Scale (VAS). The VAS is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.
Work Status at Follow-Up	Once between 1 to 4 years postoperative	current profession and working level
Radiographic Evaluation of Mobility at Follow-Up	Once between 1 to 4 years postoperative	Radiological evaluation: Fusion criteria 1: Degree of Flexion, Degree of Extension, Mobility (Extension-Flexion)
Radiographic Evaluation of Radiolucencies at Follow-Up	Once between 1 to 4 years postoperative	Radiological evaluation: Fusion criteria 3: no radiolucent line along the implant end plate (0%), mild / under 25% radiolucencies, moderate / 25-50% radiolucencies, severe / more than 50% radiolucencies
Neurological Outcome at Follow-Up	1 to 4 years follow-up	Current neurological assessment at follow-up, measured by a four-level scale: no deficit, sensory deficit, motor deficit, sensory \& motor deficit
Radiographic Evaluation of Bone Bridges at Follow-Up	Once between 1 to 4 years postoperative	Radiological evaluation: Fusion criteria 2: no bone bridges between adjacent vertebral bodies, Radiological densities visible compared to directly postop state, Bone Bridges linking adjacent vertebral bodies (anterior / posterior)

Trial Locations

Locations (1)

Hospital MAZ Zaragoza; 🇪🇸 Zaragoza, Spain