Corpectomy With Pyramesh Titanium Cage Reconstruction in Dorsolumber Metastatic Lesions

Posterolateral Corpectomy With Pyramesh Titanium Cage Reconstruction in Dorsolumber Metastatic Lesions

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.

Study Overview

• Status: Completed
• Conditions: Spinal Metastases
• Intervention / Treatment: Procedure: Posterolateral corpectomy

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: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt, 82511
    • Ahmed Salaheldin Mohammed Saro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 29 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(Quebec scale) to assess back pain in three years	(Quebec Scale) the lower scale the better is the pain	3 years
(muscle power grading scale) to evaluate motor power using in three years	(Muscle power grading) the higher the grade the better is the motor power	3 years

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Study Chair: Roshdy A Elkhayat, Professor of neurosurgery, Assuit Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 7, 2018

Study Record Updates

• Last Update Posted (Actual): December 10, 2018
• Last Update Submitted That Met QC Criteria: December 6, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Posterolateral; Corpectomy; Pyramesh; Pediculectomy; Facetectomies
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: Sohag2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No