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Corpectomy With Pyramesh Titanium Cage Reconstruction in Dorsolumber Metastatic Lesions

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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

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.


Condition or disease Intervention/treatment Phase
Spinal Metastases Procedure: Posterolateral corpectomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Posterolateral Corpectomy With Pyramesh Titanium Cage Reconstruction in Dorsolumber Metastatic Lesions
Actual Study Start Date : August 1, 2014
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : August 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
patients with metastatic spinal lesions
corpectomy
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.




Primary Outcome Measures :
  1. (Quebec scale) to assess back pain in three years [ Time Frame: 3 years ]
    (Quebec Scale) the lower scale the better is the pain

  2. (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



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Ages Eligible for Study:   33 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768167


Locations
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Egypt
Ahmed Salaheldin Mohammed Saro
Sohag, Egypt, 82511
Sponsors and Collaborators
Sohag University
Investigators
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Study Chair: Roshdy A Elkhayat, Professor of neurosurgery Assuit faculty of medicine

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Responsible Party: ahmed salaheldin mohammed saro, Assistant professor of neurosurgery, Sohag University
ClinicalTrials.gov Identifier: NCT03768167     History of Changes
Other Study ID Numbers: Sohag2
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ahmed salaheldin mohammed saro, Sohag University:
Corpectomy
Pyramesh
Posterolateral
Pediculectomy
Facetectomies