Study of Titanium-Coated PEEK Cages for Degenerative Disc Disease

Overview

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

Full Title of Study: “Prospective Follow-up Study of CeSPACE XP – Titanium Coated PEEK Cages – for the Treatment of Degenerative Cervical Disc Disease”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: December 31, 2018

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.

Arms, Groups and Cohorts

• 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.

Clinical Trial Outcome Measures

Primary Measures

• Neck Disability Index (NDI) during Follow-Up
  • Time Frame: 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 Measures

• Patient Satisfaction at Follow-Up
  • Time Frame: Once between 1 to 4 years postoperative
  • Patient self-reported satisfaction measured by a four-level scale: excellent, good, not satisfied, bad
• Neck Pain at Follow-Up
  • Time Frame: 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.
• Arm Pain during Follow-Up
  • Time Frame: 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.
• Neurological Outcome at Follow-Up
  • Time Frame: 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
• Work Status at Follow-Up
  • Time Frame: Once between 1 to 4 years postoperative
  • current profession and working level
• Radiographic Evaluation of Mobility at Follow-Up
  • Time Frame: Once between 1 to 4 years postoperative
  • Radiological evaluation: Fusion criteria 1: Degree of Flexion, Degree of Extension, Mobility (Extension-Flexion)
• Radiographic Evaluation of Bone Bridges at Follow-Up
  • Time Frame: 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)
• Radiographic Evaluation of Radiolucencies at Follow-Up
  • Time Frame: 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

Participating in This Clinical Trial

Inclusion Criteria

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

• Pregnancy – Patient consent not signed

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Aesculap AG
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Ricardo Arregui, Dr., MD, Principal Investigator, Hospital MAZ Zaragoza