Degenerative Cervical Spinal StenosisC5registryNCT02875431
Multicentric Registry for the Detection of C5 Palsy After Anterior Cervical Discectomy and Fusion
An observational study of Degenerative Cervical Spinal Stenosis and Cervical Disc Herniation, run by Technical University of Munich at 1 site in Germany.
Trial summary
Detect the reason for the frequently occurring C5 palsy after anterior cervical discectomy and fusion Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Degenerative Cervical Spinal Stenosis, Cervical Disc Herniation, Suspected Cervical Spine Instability
- What is being tested?
- Patients undergo ACDF or cervical vertebral body replacement
- Type of treatment
- Surgery or procedure
- How many people
- 1,087 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2016to Nov 2017
- How long will I take part?
- 3 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: ACDF or cervical vertebral body replacement due to herniated disc, spinal stenosis or trauma
Who may be able to join
- ACDF or cervical vertebral body replacement due to herniated disc, spinal stenosis or trauma
Who cannot join
- infectious disease or neurodegenerative disease
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Neurosurgery
Munich, Bavaria, 81675
Sandro M Krieg, MD, MBA, sandro.krieg@tum.de
About this study
Official title: Registry for the Detection of C5 Palsy After ACDF
Detect the reason for the frequently occurring C5 palsy after anterior cervical discectomy and fusion
Read the detailed description
A registry which includes all known and individually analyzed but even new factors are evaluated in order to perform a multivariate analysis for the detection of risk factors of C5 palsy after anterior cervical discectomy and fusion which is a very disabling and still cryptic complication.
- Conditions
- Degenerative Cervical Spinal Stenosis, Cervical Disc Herniation, Suspected Cervical Spine Instability
- Being tested
- Patients undergo ACDF or cervical vertebral body replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients undergo ACDF or cervical vertebral body replacementProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| ACDF or cervical vertebral body replacement | Not described Receives: Procedure: Patients undergo ACDF or cervical vertebral body replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
C5 palsy
defined as deterioration on BMRC scale of C5 innervated muscles
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Cervical Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- 1,087 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University Innsbruck, Charite University, Berlin, Germany, University Hospital, Geneva, Klinik für Neurochirurgie, Köln-Mehrheim, Wirbelsäulenzentrum, St. Josephs-Hospital, Wiesbaden, Vivantes Clinic Neukölln, Helios Klinikum Krefeld, Universitätsklinikum Hamburg-Eppendorf, Klinikum Karlsbad-Langensteinbach, Ludwig-Maximilians - University of Munich, Zentrum für Wirbelsäulenchirurgie Kempen
- Responsible party
- Sponsor
- Investigators
- Bernhard Meyer, MD, Study chair, TU München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875431
- Sponsor's protocol ID
- C5 registry
- Acronym
- C5registry
- Status last verified
- Aug 2016
- First submitted
- 12 Aug 2016
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry for the Detection of C5 Palsy After ACDF
- ClinicalTrials.gov ID
- NCT02875431
- Acronym / sponsor ID
- C5registry / C5 registry
- Conditions
- Degenerative Cervical Spinal Stenosis, Cervical Disc Herniation, Suspected Cervical Spine Instability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,087 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Medical University Innsbruck, Charite University, Berlin, Germany, University Hospital, Geneva, Klinik für Neurochirurgie, Köln-Mehrheim, Wirbelsäulenzentrum, St. Josephs-Hospital, Wiesbaden, Vivantes Clinic Neukölln, Helios Klinikum Krefeld, Universitätsklinikum Hamburg-Eppendorf, Klinikum Karlsbad-Langensteinbach, Ludwig-Maximilians - University of Munich, Zentrum für Wirbelsäulenchirurgie Kempen
- Study start
- Aug 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 23 Aug 2016 (estimated)
- 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.
Detect the reason for the frequently occurring C5 palsy after anterior cervical discectomy and fusion
Detailed description
A registry which includes all known and individually analyzed but even new factors are evaluated in order to perform a multivariate analysis for the detection of risk factors of C5 palsy after anterior cervical discectomy and fusion which is a very disabling and still cryptic complication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACDF or cervical vertebral body replacement | – | Procedure: Patients undergo ACDF or cervical vertebral body replacement |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ACDF or cervical vertebral body replacement due to herniated disc, spinal stenosis or trauma
Key inclusion criteria (1 listed)
- ACDF or cervical vertebral body replacement due to herniated disc, spinal stenosis or trauma
Key exclusion criteria (1 listed)
- infectious disease or neurodegenerative disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients undergo ACDF or cervical vertebral body replacement | Procedure or surgery | ACDF or cervical vertebral body replacement |
Primary outcome
C5 palsy
Time frame: 3 months
defined as deterioration on BMRC scale of C5 innervated muscles
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2016.
- Individual participant dataSharing planned: No
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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.
Bernhard Meyer, MD study chair
TU München
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 Degenerative Cervical Spinal Stenosis and Cervical Disc Herniation, run by Technical University of Munich at 1 site in Germany.
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 1 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: status not confirmed, as of the sponsor's last update on 23 Aug 2016. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandro M Krieg, MD, MBA (+498941409482, sandro.krieg@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C5 palsy (time frame: 3 months). 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 23 Aug 2016.