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Occipito-Cervical Stabilization Using Occipital Condyle Screw

NCT03250611 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-08-15

No results posted yet for this study

Summary

The Occipito-Cervical (OC) junction is the most cephalad portion of the spinal axis, with anatomical osseous complex that allows significant mobility while maintaining biomechanical stability. OC instability is a rare disorder with potentially life-threatening consequences. Instability may manifest as disabling pain, cranial nerve dysfunction, paralysis, or even sudden death. The most common acute presentation is secondary to major trauma. Other pathologic processes that may lead to chronic instability include rheumatoid arthritis, infections, tumors, and even congenital malformations; OC fusion in aforementioned cases each according is then indicated.

Stabilization of the OC junction remains a challenge, owing to the regional anatomy and poor occipital bone purchase. OC stabilization techniques have undergone continuous refinement. Early techniques involving simple posterior only bone grafts demonstrated a high rate of failure and have largely been replaced by rigid posterior fixation systems using rods/screws or plates, providing superior biomechanical stability and higher rates of fusion. One of the very modern modalities of fixation methods is the Occipital Condyle Screw (OCS) as a sole cranial anchor; believing that decreasing the length of lever arm of the construct, increasing the length of the screw purchase, and decreasing stresses addressed on the rod with no need to excessively bend it for the occipital slope may enhance the construct rigidity, and leaving a greater clear metal-free area of the occiput for graft contact may have a real potential benefits in fusion rates.

Conditions

  • Cervical Instabilities Spine

Interventions

PROCEDURE

Occipital Condyle Screw

Occipito-Cervical Screw-Rod Fixation Technique

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Mohamed El-Meshtawy, MD · Assiut University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-30
Primary Completion
2019-06-30
Completion
2020-01-31

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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 NCT03250611 on ClinicalTrials.gov