Clincosm LogoSign in Get a demo

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

Sponsor
Ataturk University (Other)
Overall Status
Completed
CT.gov ID
NCT05262478
Collaborator
(none)
33
Enrollment
1
Location
1.5
Actual Duration (Months)
22.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Alpha-D CDP

Study Design

Study Type:
Observational
Actual Enrollment :
33 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Medium-Term Radiological And Clinical Follow-Up of Alpha-D Cervical Disk Prosthesis
Actual Study Start Date :
Jan 1, 2022
Actual Primary Completion Date :
Feb 1, 2022
Actual Study Completion Date :
Feb 15, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Heterotropic ossification [Postoperative 18-78.months]

    McAfee-Mehren classification

Secondary Outcome Measures

  1. visual analog scale [4 and 12 months after surgery]

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

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
27 Years to 59 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ataturk University Erzurum Yakutiye Turkey

Sponsors and Collaborators

  • Ataturk University

Investigators

  • Principal Investigator: Mehmet K Karadag, Mehmet Kursat Karadag

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mehmet Kursat Karadag, Principal Investigator, Ataturk University
ClinicalTrials.gov Identifier:
NCT05262478
Other Study ID Numbers:
  • ATANEUROSURGERY-2
First Posted:
Mar 2, 2022
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 2, 2022