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Corpectomy With Pyramesh Titanium Cage Reconstruction in Dorsolumber Metastatic Lesions

NCT ID: NCT03768167

Last Updated: 2018-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-01

Study Completion Date

2017-08-01

Brief Summary

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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

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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.

Conditions

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Spinal Metastases

Keywords

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Corpectomy Pyramesh Posterolateral Pediculectomy Facetectomies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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patients with metastatic spinal lesions

corpectomy

Group Type OTHER

Posterolateral corpectomy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

33 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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ahmed salaheldin mohammed saro

Assistant professor of neurosurgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roshdy A Elkhayat, Professor of neurosurgery

Role: STUDY_CHAIR

Assuit faculty of medicine

Locations

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Ahmed Salaheldin Mohammed Saro

Sohag, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Sohag2

Identifier Type: -

Identifier Source: org_study_id