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

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

Study Overview

• Status: Completed
• Conditions: Spinal Fusion; Cervical Vertebral Fusion

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Spain
  • Zaragoza, Spain, 50015
    • Hospital MAZ Zaragoza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

adult patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cespace; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Work Status at Follow-Up	current profession and working level	Once between 1 to 4 years postoperative
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Aesculap AG
• Investigators: Principal Investigator: Ricardo Arregui, Dr., MD, Hospital MAZ Zaragoza

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2018
• Primary Completion (ACTUAL): December 31, 2018
• Study Completion (ACTUAL): December 31, 2018

Study Registration Dates

• First Submitted: May 25, 2018
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (ACTUAL): June 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 30, 2019
• Last Update Submitted That Met QC Criteria: April 29, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Postoperative complications; Radiography; Spinal fusion; Cervical vertebrae; Coating
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Bone Diseases; Musculoskeletal Abnormalities; Bone Diseases, Developmental; Dysostoses; Klippel-Feil Syndrome
• Other Study ID Numbers: AAG-O-H-1702