Spinal FusionNCT03565224
Study of Titanium-Coated PEEK Cages for Degenerative Disc Disease
An observational study of Spinal Fusion and Cervical Vertebral Fusion, run by Aesculap AG at 1 site in Spain.
Trial summary
Prospective Follow-up study of CeSPACE XP coated PEEK cages for the treatment of degenerative cervical disc disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Fusion, Cervical Vertebral Fusion
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2018to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients
Who may be able to join
- All consecutive patients who received a CeSPACE XP cage between August 2013 and January 2017
Who cannot join
- Pregnancy
- Patient consent not signed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Spinal Fusion, Cervical Vertebral Fusion
- Keywords
- Cervical vertebrae, Postoperative complications, Radiography, Spinal fusion, Coating
- Medical subject headings
- Klippel-Feil Syndrome, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Once between 1 to 4 years postoperative
Secondary outcomes (8)
Patient Satisfaction at Follow-Up
Patient self-reported satisfaction measured by a four-level scale: excellent, good, not satisfied, bad
Measured: 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.
Measured: 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.
Measured: 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
Measured: 1 to 4 years follow-up
Work Status at Follow-Up
current profession and working level
Measured: 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)
Measured: 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)
Measured: 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
Measured: Once between 1 to 4 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start10 Jan 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal FusionStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ricardo Arregui, Dr., MD, Principal investigator, Hospital MAZ Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565224
- Sponsor's protocol ID
- AAG-O-H-1702
- Status last verified
- Apr 2019
- First submitted
- 25 May 2018
- Last updated
- 30 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Follow-up Study of CeSPACE XP - Titanium Coated PEEK Cages - for the Treatment of Degenerative Cervical Disc Disease
- ClinicalTrials.gov ID
- NCT03565224
- Acronym / sponsor ID
- AAG-O-H-1702
- Conditions
- Spinal Fusion, Cervical Vertebral Fusion
- Keywords
- Cervical vertebrae, Postoperative complications, Radiography, Spinal fusion, Coating
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 21 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients
Key inclusion criteria (1 listed)
- All consecutive patients who received a CeSPACE XP cage between August 2013 and January 2017
Key exclusion criteria (2 listed)
- Pregnancy
- Patient consent not signed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
Patient Satisfaction at Follow-Up
Time frame: Once between 1 to 4 years postoperative
Neck Pain at Follow-Up
Time frame: Once between 1 to 4 years postoperative
Arm Pain during Follow-Up
Time frame: Once between 1 to 4 years postoperative
Neurological Outcome at Follow-Up
Time frame: 1 to 4 years follow-up
Work Status at Follow-Up
Time frame: Once between 1 to 4 years postoperative
Radiographic Evaluation of Mobility at Follow-Up
Time frame: Once between 1 to 4 years postoperative
Radiographic Evaluation of Bone Bridges at Follow-Up
Time frame: Once between 1 to 4 years postoperative
Radiographic Evaluation of Radiolucencies at Follow-Up
Time frame: Once between 1 to 4 years postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
Related trials for Spinal Fusion
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
RecruitingObservational study
Lumbar & Sacroiliac Fusion Study Involving Previously Implanted Devices
Fusion of Spine, Sacroiliac; Fusion
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo Arregui, Dr., MD principal investigator
Hospital MAZ Zaragoza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Fusion and Cervical Vertebral Fusion, run by Aesculap AG at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index (NDI) during Follow-Up (time frame: Once between 1 to 4 years postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019.