Cervical Disc DisordersNCT02498028
Clinical Outcome After Anterior Cervical Decompression and Fusion and Cervical Total Disc Replacement
An observational study of Cervical Disc Disorders, run by University Hospital, Bonn at 2 sites in Germany.
Trial summary
The aim of this study is to examine the clinical outcome after anterior cervical decompression and fusion, and cervical disc prostheses in general. Additionally these two surgical methods for degenerative diseases of the cercival spine are analyzed comparatively in order to see whether one procedure should be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Disc Disorders
- What is being tested?
- Cervical Fusion and Cervical disc Prostheses
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2011to Aug 2015
- 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: Patients of the University Hospital of Bonn who are suffering from neck and cervicobrachial pain that cannot be treated anymore by conservative methods and have to undergo surgery such as cervical fusion or cevical disc arthroplasty.
Who may be able to join
- All patients who have to undergo surgery such as spondylodesis or disc prosthesis of the cervical spine because of degenerative diseases and who have been operated in the University Hospital of Bonn between 2011 and 2015.
Who cannot join
- Patients under the age of 18 years
- Pregnant women
- Patients who are not willing to participate in the study
- Patients unable to take part in the study because of any other known restriction or incompatibility
Trial locations and contacts
2 sites in 1 country.
Robert Pflugmacher, PD Dr. med contact
Yorck Rommelspacher, Dr. med contact
Germany2 sites, 2 recruiting
- Recruiting
Universitiy Hospital of Bonn
Bonn, North Rhine-Westphalia, 53127
Charlotte Struwe, struwe.charlotte@web.de
- Recruiting
University hospital Bonn
Bonn, 53127
Yorck Rommelspacher, Dr. med, yorck.rommelspacher@ukb.uni-bonn.de
About this study
The aim of this study is to examine the clinical outcome after anterior cervical decompression and fusion, and cervical disc prostheses in general. Additionally these two surgical methods for degenerative diseases of the cercival spine are analyzed comparatively in order to see whether one procedure should be preferred.
Read the detailed description
The study population consists of patients who are suffering from neck and cervicobrachial pain because of degenerative diseases of the cervical spine. In that population conservative treatment such as analgesia and physiotherapy is no more sufficient, so that surgery is necessary. For surgical treatment are chosen either total disc replacement with an cervical disc prostheses or anterior cervical decompression and fusion.
In the context of this work the clinical success of these surgical methods should be analasied by means of the neck disability index (NDI), the visual analogue scale (VAS) in centimeter, clinical examinations, the satisfaction of patients with the surgery and the occurrence of adverse events. The included patients are examined and seen before and after the surgery.
Furthermore the two different methods are compared to each other in order to detect a possible advantage of one type of surgery.
- Conditions
- Cervical Disc Disorders
- Being tested
- Cervical Fusion, Cervical disc Prostheses
- Keywords
- cervical fusion, cervical arthroplasty, cervicobrachial pain
- Medical subject headings
- Klippel-Feil Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical FusionProcedure or surgery
Cervical Fusion is performed with a titanium cage (Company Peter Brehm, Weisendorf, Germany) and a plating system (Company Aesculap, ABC plating system, Tuttlingen, Germany)
Cervical disc ProsthesesProcedure or surgery
The total disc replacement is performed with eiter a Freedom® Cervical Disc, AxioMed Spine Corporation, Garfield Heights, Ohio, USA or Active® C, Company, Aesculap, Tuttlingen, Germany
| Study group | Role | What they receive |
|---|---|---|
| Cervical Fusion | patients with anterior cerivical decompression and fusion Receives: Procedure: Cervical Fusion | |
| Cervical Disc Prostheses | patients with cervical total disc replacement Receives: Procedure: Cervical disc Prostheses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain as assessed by VAS
Pain objectified by the VAS
Measured: Preoperative (baseline day 0), Follow up (24 months)
Secondary outcomes (1)
Change in Neck disability Index
Restrictions in patients' daily life objecitfied by the NDI (neck disabiliy index)
Measured: Preoperative (baseline day 0), Follow up (24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startJan 2011
- Primary completionJun 2015
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Disc DisordersStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Yorck Rommelspacher, University Hospital, Bonn
- Investigators
- Yorck Rommelspacher, Dr. med, Principal investigator, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498028
- Sponsor's protocol ID
- UKBORTYC01
- Status last verified
- Jul 2015
- First submitted
- 2 May 2015
- Last updated
- 15 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome After Anterior Cervical Decompression and Fusion and Cervical Total Disc Replacement
- ClinicalTrials.gov ID
- NCT02498028
- Acronym / sponsor ID
- UKBORTYC01
- Conditions
- Cervical Disc Disorders
- Keywords
- cervical fusion, cervical arthroplasty, cervicobrachial pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (estimated)
- First posted
- 15 Jul 2015 (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.
The aim of this study is to examine the clinical outcome after anterior cervical decompression and fusion, and cervical disc prostheses in general. Additionally these two surgical methods for degenerative diseases of the cercival spine are analyzed comparatively in order to see whether one procedure should be preferred.
Detailed description
The study population consists of patients who are suffering from neck and cervicobrachial pain because of degenerative diseases of the cervical spine. In that population conservative treatment such as analgesia and physiotherapy is no more sufficient, so that surgery is necessary. For surgical treatment are chosen either total disc replacement with an cervical disc prostheses or anterior cervical decompression and fusion.
In the context of this work the clinical success of these surgical methods should be analasied by means of the neck disability index (NDI), the visual analogue scale (VAS) in centimeter, clinical examinations, the satisfaction of patients with the surgery and the occurrence of adverse events. The included patients are examined and seen before and after the surgery.
Furthermore the two different methods are compared to each other in order to detect a possible advantage of one type of surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical Fusion | – | Procedure: Cervical Fusionpatients with anterior cerivical decompression and fusion |
| Cervical Disc Prostheses | – | Procedure: Cervical disc Prosthesespatients with cervical total disc replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the University Hospital of Bonn who are suffering from neck and cervicobrachial pain that cannot be treated anymore by conservative methods and have to undergo surgery such as cervical fusion or cevical disc arthroplasty.
Key inclusion criteria (1 listed)
- All patients who have to undergo surgery such as spondylodesis or disc prosthesis of the cervical spine because of degenerative diseases and who have been operated in the University Hospital of Bonn between 2011 and 2015.
Key exclusion criteria (4 listed)
- Patients under the age of 18 years
- Pregnant women
- Patients who are not willing to participate in the study
- Patients unable to take part in the study because of any other known restriction or incompatibility
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 |
|---|---|---|
| Cervical FusionCervical Fusion is performed with a titanium cage (Company Peter Brehm, Weisendorf, Germany) and a plating system (Company Aesculap, ABC plating system, Tuttlingen, Germany) | Procedure or surgery | Cervical Fusion |
| Cervical disc ProsthesesThe total disc replacement is performed with eiter a Freedom® Cervical Disc, AxioMed Spine Corporation, Garfield Heights, Ohio, USA or Active® C, Company, Aesculap, Tuttlingen, Germany | Procedure or surgery | Cervical Disc Prostheses |
Primary outcome
Change in pain as assessed by VAS
Time frame: Preoperative (baseline day 0), Follow up (24 months)
Pain objectified by the VAS
1 secondary outcome
Change in Neck disability Index
Time frame: Preoperative (baseline day 0), Follow up (24 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
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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.
Robert Pflugmacher, PD Dr. med contact
Yorck Rommelspacher, Dr. med contact
Yorck Rommelspacher, Dr. med principal investigator
University Hospital, Bonn
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Disc Disorders, run by University Hospital, Bonn at 2 sites 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 4 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 15 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Robert Pflugmacher, PD Dr. med (robert.pflugmacher@ukb.uni-bonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain as assessed by VAS (time frame: Preoperative (baseline day 0), Follow up (24 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 15 Jul 2015.