Medium-Term Follow-Up of Alpha-D Cervical Disk Prosthesis

Cervical Disc Disease Clinical Trial

Official title:

Medium-Term Radiological And Clinical Follow-Up of Alpha-D Cervical Disk Prosthesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05262478
• Other study ID #: ATANEUROSURGERY-2
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Cervical Disc Disease

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