NCT04627454

Brief Summary

  • Evaluation of outcome of DCI in treatment of cervical disc disease to patients admitted to neurosurgery department, Asyut University Hospitals.
  • Give the effective treatment, pain control and can detect the best method could be used.
  • Improve the outcome of these patients and decease rate of recurrence and complications.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

November 25, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

7 months

First QC Date

September 1, 2020

Last Update Submit

November 8, 2020

Conditions

Cervical Disc DiseaseCervical Disc HerniationCervical Disc Degeneration

Keywords

Dynamic cervical implant

Outcome Measures

Primary Outcomes (2)

  • Change of preoperative neck and radicular pain

    Pain measurement post op. To evaluate the effectiveness of DCI ( by Oswestry disability index ) that is measured through 10 questions each is. Scored from 0 to 5. A maximum score of 50, then multiply the results by 2 . Scores are stratified into severity: 0-20 minor disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippling bback bain, 81-100 either patients are bed ridden or they are exaggerated their symptoms.

    Two days post operative

  • Evaluation the motor power

    Evaluation patients' motor activity comparing preoperative and postoperative motor power.Assessment of motor function can be graded in patients able to obey commands as follows (right compared to left.

    Three months

Study Arms (2)

dynamic cervical implant

EXPERIMENTAL

dynamic cervical implant in treatment of cervical disc disease

Procedure: Discectomy and insertion of dynamic cervical implant in cervical disc herniation

discectomy

EXPERIMENTAL

insertion of dynamic cervical implant post cervical discectomy single level

Procedure: Discectomy and insertion of dynamic cervical implant in cervical disc herniation

Interventions

Discectomy and insertion of dynamic cervical implant in cervical disc herniationPROCEDURE

The surgical technique included the use of a conventional anterior cervical approach and discectomy and insertion of dynamic cervical implant after discectomy without fixation

discectomydynamic cervical implant

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with single level cervical disc herniation ( C3 - C7 ).
  • Patients with cervical canal stenosis.
  • Patients with degenerative disc disease.
  • Patient with cervical disc disease not responding to medical treatment.
  • Age of the patient: any age.
  • Patients fit for surgery.

You may not qualify if:

  • Patients with multilevel cervical disc herniation.
  • Patients with segmental instability.
  • Patients with previous cervical spine surgery.
  • Patients with cervical kyphosis, active infection or known allergy to titanium.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Interventions

Diskectomy

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresTherapeuticsDecompression, SurgicalSurgical Procedures, Operative

Study Officials

  • Abdel Hai Moussa Abdel Latif, prof.

    Assiut university hospital, neurosurgery department

    STUDY DIRECTOR

  • Ahmed Elsayed Abo Kresha, prof.

    Assiut university hospital, neurosurgery department

    STUDY DIRECTOR

  • Mohammed Elsayed Mahmoud, Prof.

    Assiut university hospital, neurosurgery department

    STUDY DIRECTOR

Central Study Contacts

Fahd Abdel Sabour Ahmed Mohammed, Rdr

CONTACT

00201029522851dfahd81@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, Resident doctor, neurosurgery department

Study Record Dates

First Submitted

September 1, 2020

First Posted

November 13, 2020

Study Start

November 25, 2020

Primary Completion

July 1, 2021

Study Completion

December 15, 2021

Last Updated

November 13, 2020

Record last verified: 2020-11