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Corpectomy With Pyramesh Titanium Cage Reconstruction in Dorsolumber Metastatic Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03768167
Recruitment Status : Completed
First Posted : December 7, 2018
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
ahmed salaheldin mohammed saro, Sohag University

Tracking Information
First Submitted Date  ICMJE December 5, 2018
First Posted Date  ICMJE December 7, 2018
Last Update Posted Date December 10, 2018
Actual Study Start Date  ICMJE August 1, 2014
Actual Primary Completion Date August 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
  • (Quebec scale) to assess back pain in three years [ Time Frame: 3 years ]
    (Quebec Scale) the lower scale the better is the pain
  • (muscle power grading scale) to evaluate motor power using in three years [ Time Frame: 3 years ]
    (Muscle power grading) the higher the grade the better is the motor power
Original Primary Outcome Measures  ICMJE
 (submitted: December 5, 2018)
  • assess back pain using Quebec scale in three years [ Time Frame: 3 years ]
    (Quebec Scale) the lower scale the better is the pain
  • Evaluate motor power using muscle power grading in three years [ Time Frame: 3 years ]
    (Muscle power grading) the higher the grade the better is the motor power
Change History Complete list of historical versions of study NCT03768167 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Corpectomy With Pyramesh Titanium Cage Reconstruction in Dorsolumber Metastatic Lesions
Official Title  ICMJE Posterolateral Corpectomy With Pyramesh Titanium Cage Reconstruction in Dorsolumber Metastatic Lesions
Brief Summary

The vertebral column represents the most common bony site for metastasis with an incidence ranged from 30% to 70% in patients with metastatic neoplasms. The dorsal spine carries the highest frequent site for metastasis all over the vertebral column followed by the lumber spine. These metastatic lesions are clinical entities that often necessitate a complex spinal decompression and anterior reconstruction. Posterolateral approaches alone allow for excellent decompression with transpedicular fixation and safe visualization of the neural elements for corpectomy and reconstruction so the investigators can avoid the complications that can be happened with the staged surgery.

Purpose: investigators' aim in the study is to report cases and evaluate investigators' approach for fixation and assess the postoperative period regarding pain improvement and neurological deficit.

Detailed Description At neurosurgery department in Sohag faculty of medicine, Between August 2014 and August 2017, 26 patients with single dorsolumbar metastatic spinal lesions with vertebral body collapse underwent a single-stage, circumferential corpectomy and anterior spinal reconstruction with a pyramesh titanium cage via a midline, posterior and lateral approach. Investigators included in the study patients with retropulsed fragment inside the canal that causes spinal cord compression with neurological manifestation. Metastatic work up was done for cases. Exclusion criteria include patients with more than one spinal metastases or extra-spinal metastasis, patients with other comorbidities as cardiac ill patients, patients with chronic renal failure and patients who received radiotherapy or chemotherapy within one year before surgery. A preoperative neurological assessment, full laboratory investigations were done. Investigators used the Quebec scale to assess the patients' improvement regarding pain, and muscle power scale to evaluate the motor.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Metastases
Intervention  ICMJE Procedure: Posterolateral corpectomy
Investigators' goal in this study is to report clinical series of 26 patients in Sohag university hospital with dorsolumbar metastatic lesions from different primaries treated by single-stage posterolateral circumferential corpectomy with reconstruction by a pyramesh titanium cage and account the degree of improvement regarding the pain.
Study Arms  ICMJE patients with metastatic spinal lesions
corpectomy
Intervention: Procedure: Posterolateral corpectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 5, 2018)
26
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 1, 2017
Actual Primary Completion Date August 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients with retropulsed fragment inside the canal that causes spinal cord compression with neurological manifestation.

Exclusion Criteria:

  • patients with more than one spinal metastases or extra-spinal metastasis.
  • patients with other comorbidities as cardiac ill patients, patients with chronic renal failure.
  • patients who received radiotherapy or chemotherapy within one year before surgery.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 33 Years to 67 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03768167
Other Study ID Numbers  ICMJE Sohag2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ahmed salaheldin mohammed saro, Sohag University
Study Sponsor  ICMJE Sohag University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Roshdy A Elkhayat, Professor of neurosurgery Assuit faculty of medicine
PRS Account Sohag University
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP