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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05262478
Other study ID # ATANEUROSURGERY-2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date February 15, 2022

Study information

Verified date February 2022
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date February 15, 2022
Est. primary completion date February 1, 2022
Accepts healthy volunteers No
Gender All
Age group 27 Years to 59 Years
Eligibility Inclusion Criteria: - cervical disc hernia - underwent cervical discectomy and received cervical disc prostheses Exclusion Criteria: - history of cervical surgery, - kyphotic deformity, - rheumatological or other systemic diseases, - severe osteophytes caused by advanced degenerative disc disease - severe spinal stenosis

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Alpha-D CDP
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.

Locations

Country Name City State
Turkey Ataturk University Erzurum Yakutiye

Sponsors (1)

Lead Sponsor Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. Review. — View Citation

Park 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Heterotropic ossification McAfee-Mehren classification Postoperative 18-78.months
Secondary visual analog scale (0-10, 0=no pain, 10=extreme pain) 4 and 12 months after surgery
Secondary 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. 4 and 12 months after surgery
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