Cervical Disc DiseaseNCT05262478
Medium-Term Follow-Up of Alpha-D Cervical Disk Prosthesis
An observational study of Cervical Disc Disease, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Prostheses use subsequently became prevalent and a number of studies were conducted. However, prosthesis-associated heterotropic ossification (HO) in the segments with prostheses was reported in 2005, which disrupted mobility and caused fusion. Read more about this study
- Who is it for?
- Ages 27 to 59 years
- Conditions the study is for
- Cervical Disc Disease
- What is being tested?
- Alpha-D CDP
- Type of treatment
- Medical device
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 15 Feb 2022
- 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 27 to 59 years
- All sexes
- No healthy volunteers
- Adult
Study population: We included 33 patients with cervical disc hernia and associated radiculopathy upon radiological examination, who underwent a cervical discectomy and received cervical disc protheses (CDP; arthroplasty) with a single-level anterior discectomy.
Who may be able to join
- cervical disc hernia
- underwent cervical discectomy and received cervical disc prostheses
Who cannot join
- history of cervical surgery,
- kyphotic deformity,
- rheumatological or other systemic diseases,
- severe osteophytes caused by advanced degenerative disc disease
- severe spinal stenosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medium-Term Radiological And Clinical Follow-Up of Alpha-D Cervical Disk Prosthesis
Prostheses use subsequently became prevalent and a number of studies were conducted. However, prosthesis-associated heterotropic ossification (HO) in the segments with prostheses was reported in 2005, which disrupted mobility and caused fusion.
In the present study, we aimed to investigate the clinical outcomes, HO incidence, and prosthesis mobility in the patients following the operative use of Alpha-D disc prosthesis as developed and used by the authors to treat cervical disk diseases.
- Conditions
- Cervical Disc Disease
- Being tested
- Alpha-D CDP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-D CDPDevice
Alpha-D cervical disc prosthesis was developed jointly by the Spine Center of Koç University Faculty of Medicine and Toledo University Bioengineering Department. It was designed as a single unit to ensure user-friendly administration for surgeons, and it was designed and manufactured to reproduce the movements of the normal cervical movement segment.
| Study group | Role | What they receive |
|---|---|---|
| Alpha-D cervical disc prosthesis | Alpha-D cervical disc prosthesis was developed jointly by the Spine Center of Koç University Faculty of Medicine and Toledo University Bioengineering Department. It was designed as a single unit to ensure user-friendly administration for surgeons, and it was designed and manufactured to reproduce the movements of the normal cervical movement segment. Receives: Device: Alpha-D CDP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heterotropic ossification
McAfee-Mehren classification
Measured: Postoperative 18-78.months
Secondary outcomes (2)
visual analog scale
(0-10, 0=no pain, 10=extreme pain)
Measured: 4 and 12 months after surgery
neck disability index
The questionnaire has 10 items concerning pain and activities of daily living including personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation.
Measured: 4 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Jan 2022
- Primary completion1 Feb 2022
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical Disc DiseaseStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe 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
- Retrospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Kursat Karadag, Ataturk University
- Investigators
- Mehmet K Karadag, Principal investigator, Mehmet Kursat Karadag
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262478
- Sponsor's protocol ID
- ATANEUROSURGERY-2
- Status last verified
- Feb 2022
- First submitted
- 21 Feb 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Leven D, Meaike J, Radcliff K, Qureshi S. Cervical disc replacement surgery: indications, technique, and technical pearls. Curr Rev Musculoskelet Med. 2017 Jun;10(2):160-169. doi: 10.1007/s12178-017-9398-3.
PubMed 28493215Park JH, Rhim SC, Roh SW. Mid-term follow-up of clinical and radiologic outcomes in cervical total disk replacement (Mobi-C): incidence of heterotopic ossification and risk factors. J Spinal Disord Tech. 2013 May;26(3):141-5. doi: 10.1097/BSD.0b013e31823ba071.
PubMed 22105106
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medium-Term Radiological And Clinical Follow-Up of Alpha-D Cervical Disk Prosthesis
- ClinicalTrials.gov ID
- NCT05262478
- Acronym / sponsor ID
- ATANEUROSURGERY-2
- Conditions
- Cervical Disc Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 2 Mar 2022 (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.
Prostheses use subsequently became prevalent and a number of studies were conducted. However, prosthesis-associated heterotropic ossification (HO) in the segments with prostheses was reported in 2005, which disrupted mobility and caused fusion.
In the present study, we aimed to investigate the clinical outcomes, HO incidence, and prosthesis mobility in the patients following the operative use of Alpha-D disc prosthesis as developed and used by the authors to treat cervical disk diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alpha-D cervical disc prosthesis | – | Device: Alpha-D CDPAlpha-D cervical disc prosthesis was developed jointly by the Spine Center of Koç University Faculty of Medicine and Toledo University Bioengineering Department. It was designed as a single unit to ensure user-friendly administration for surgeons, and it was designed and manufactured to reproduce the movements of the normal cervical movement segment. |
Who may qualify
- Ages
- 27 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- We included 33 patients with cervical disc hernia and associated radiculopathy upon radiological examination, who underwent a cervical discectomy and received cervical disc protheses (CDP; arthroplasty) with a single-level anterior discectomy.
Key inclusion criteria (2 listed)
- cervical disc hernia
- underwent cervical discectomy and received cervical disc prostheses
Key exclusion criteria (5 listed)
- history of cervical surgery,
- kyphotic deformity,
- rheumatological or other systemic diseases,
- severe osteophytes caused by advanced degenerative disc disease
- severe spinal stenosis
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 |
|---|---|---|
| Alpha-D CDPAlpha-D cervical disc prosthesis was developed jointly by the Spine Center of Koç University Faculty of Medicine and Toledo University Bioengineering Department. It was designed as a single unit to ensure user-friendly administration for surgeons, and it was designed and manufactured to reproduce the movements of the normal cervical movement segment. | Device | Alpha-D cervical disc prosthesis |
Primary outcome
Heterotropic ossification
Time frame: Postoperative 18-78.months
McAfee-Mehren classification
2 secondary outcomes
visual analog scale
Time frame: 4 and 12 months after surgery
neck disability index
Time frame: 4 and 12 months after surgery
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 2 Mar 2022.
- Background: PubMed 28493215Leven D, Meaike J, Radcliff K, Qureshi S. Cervical disc replacement surgery: indications, technique, and technical pearls. Curr Rev Musculoskelet Med. 2017 Jun;10(2):160-169. doi: 10.1007/s12178-017-9398-3.
- Background: PubMed 22105106Park JH, Rhim SC, Roh SW. Mid-term follow-up of clinical and radiologic outcomes in cervical total disk replacement (Mobi-C): incidence of heterotopic ossification and risk factors. J Spinal Disord Tech. 2013 May;26(3):141-5. doi: 10.1097/BSD.0b013e31823ba071.
- Individual participant dataSharing planned: Undecided
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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.
Mehmet K Karadag principal investigator
Mehmet Kursat Karadag
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 Cervical Disc Disease, run by Ataturk University at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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 2 Mar 2022. 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 Turkey (Türkiye). 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?
Heterotropic ossification (time frame: Postoperative 18-78.months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05262478, which also lists 2 linked publications.
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 2 Mar 2022.