Skip to main content
OpenTrials
Completed

NCT Number: NCT03565224

Study of Titanium-Coated PEEK Cages for Degenerative Disc Disease

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spinal Fusion Bone Diseases Bone Diseases, Developmental Cervical Vertebral Fusion Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dysostoses Klippel-Feil Syndrome Musculoskeletal Abnormalities Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital MAZ Zaragoza

Zaragoza, 50015, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnancy
  • Patient consent not signed

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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

  5. Work Status at Follow-Up

    Time frame: Once between 1 to 4 years postoperative

    current profession and working level

  6. 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)

  7. 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)

  8. 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

Other outcomes

  1. Rate of Patients with Adverse Events and Serious Adverse Events during Follow-up

    Time frame: Up to 4 years postoperative

    Number of Patients who had potential reoperations and revisions

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 21, 2018
Registry last updated
Apr 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.