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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05262478

Enrollment

Registered

2022-03-02

Start date

2022-01-01

Completion date

2022-02-15

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Disc Disease

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.

Interventions

DEVICEAlpha-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.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

27 Years to 59 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Heterotropic ossification	Postoperative 18-78.months	McAfee-Mehren classification

Secondary

Measure	Time frame	Description
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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026