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

NCT05262478 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 33

Last updated 2022-03-02

No results posted yet for this study

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.

Conditions

  • Cervical Disc Disease

Interventions

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.

Sponsors & Collaborators

  • Ataturk University

    lead OTHER

Principal Investigators

  • Mehmet K Karadag · Mehmet Kursat Karadag

Eligibility

Min Age
27 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2022-02-01
Completion
2022-02-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05262478 on ClinicalTrials.gov