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

February 21, 2022 updated by: Mehmet Kursat Karadag, Ataturk University

Medium-Term Radiological And Clinical 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Yakutiye
      • Erzurum, Yakutiye, Turkey
        • Ataturk University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

27 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We included 33 patients with cervical disc hernia and associated radiculopathy upon radiological examination, who underwent a cervical discectomy and received cervical disc protheses (CDP; arthroplasty) with a single-level anterior discectomy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Alpha-D cervical disc prosthesis
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heterotropic ossification
Time Frame: Postoperative 18-78.months
McAfee-Mehren classification
Postoperative 18-78.months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual analog scale
Time Frame: 4 and 12 months after surgery
(0-10, 0=no pain, 10=extreme pain)
4 and 12 months after surgery
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.
4 and 12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Investigators

  • Principal Investigator: Mehmet K Karadag, Mehmet Kursat Karadag

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

February 1, 2022

Study Completion (Actual)

February 15, 2022

Study Registration Dates

First Submitted

February 21, 2022

First Submitted That Met QC Criteria

February 21, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 21, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • ATANEUROSURGERY-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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