Study of Titanium-Coated PEEK Cages for Degenerative Disc Disease

Spinal Fusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03565224
• Other study ID #: AAG-O-H-1702
• Status: Completed
• Start date: January 10, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2019
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy

• Patient consent not signed

Related Conditions & MeSH terms

• Cervical Vertebral Fusion
• Klippel-Feil Syndrome
• Spinal Fusion

Locations

Country	Name	City	State
Spain	Hospital MAZ Zaragoza	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of Patients with Adverse Events and Serious Adverse Events during Follow-up	Number of Patients who had potential reoperations and revisions	Up to 4 years postoperative
Primary	Neck Disability Index (NDI) during Follow-Up	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.	Once between 1 to 4 years postoperative
Secondary	Patient Satisfaction at Follow-Up	Patient self-reported satisfaction measured by a four-level scale: excellent, good, not satisfied, bad	Once between 1 to 4 years postoperative
Secondary	Neck Pain at Follow-Up	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.	Once between 1 to 4 years postoperative
Secondary	Arm Pain during Follow-Up	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.	Once between 1 to 4 years postoperative
Secondary	Neurological Outcome at Follow-Up	Current neurological assessment at follow-up, measured by a four-level scale: no deficit, sensory deficit, motor deficit, sensory & motor deficit	1 to 4 years follow-up
Secondary	Work Status at Follow-Up	current profession and working level	Once between 1 to 4 years postoperative
Secondary	Radiographic Evaluation of Mobility at Follow-Up	Radiological evaluation: Fusion criteria 1: Degree of Flexion, Degree of Extension, Mobility (Extension-Flexion)	Once between 1 to 4 years postoperative
Secondary	Radiographic Evaluation of Bone Bridges at Follow-Up	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)	Once between 1 to 4 years postoperative
Secondary	Radiographic Evaluation of Radiolucencies at Follow-Up	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	Once between 1 to 4 years postoperative