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Completed

NCT Number: NCT05262478

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

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.

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Key information

Conditions

Cervical Disc Disease

Age range

27 year–59 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ataturk University

Erzurum, Yakutiye, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alpha-D CDP

Device

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 outcomes

  1. Heterotropic ossification

    Time frame: Postoperative 18-78.months

    McAfee-Mehren classification

Secondary outcomes

  1. visual analog scale

    Time frame: 4 and 12 months after surgery

    (0-10, 0=no pain, 10=extreme pain)

  2. neck disability index

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 2, 2022
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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