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Clinical Trials/NCT05262478
NCT05262478
Completed
Not Applicable

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

Ataturk University1 site in 1 country33 target enrollmentStarted: January 1, 2022Last updated:
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ConditionsCervical Disc Disease

Overview

Phase
Not Applicable
Status
Completed
Enrollment
33
Locations
1
Primary Endpoint
Heterotropic ossification
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
27 Years to 59 Years (Adult)
Sex
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

Outcomes

Primary Outcomes

Heterotropic ossification

Time Frame: Postoperative 18-78.months

McAfee-Mehren classification

Secondary Outcomes

  • visual analog scale(4 and 12 months after surgery)
  • neck disability index(4 and 12 months after surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mehmet Kursat Karadag

Principal Investigator

Ataturk University

Study Sites (1)

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