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

Completed

• Conditions: Cervical Disc Disease
• Interventions: Device: Alpha-D CDP

• Registration Number: NCT05262478
• Lead Sponsor: Ataturk University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2022-02
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-15
• Study First Submitted: 2022-02-21
• Study First Submitted QC: 2022-02-21
• Last Update Submitted: 2022-02-21
• Study First Posted: 2022-03-02
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Alpha-D cervical disc prosthesis	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.

Primary Outcome Measures

Name	Time	Method
Heterotropic ossification	Postoperative 18-78.months	McAfee-Mehren classification

Secondary Outcome Measures

Name	Time	Method
visual analog scale	4 and 12 months after surgery	(0-10, 0=no pain, 10=extreme pain)
neck disability index	4 and 12 months after surgery	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.

Trial Locations

Locations (1)

Ataturk University; 🇹🇷 Erzurum, Yakutiye, Turkey