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NCT Number: NCT03768167

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.

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Key information

Conditions

Spinal Metastases

Age range

33 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ahmed Salaheldin Mohammed Saro

Sohag, 82511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Posterolateral corpectomy

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.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Posterolateral Corpectomy With Pyramesh Titanium Cage Reconstruction in Dorsolumber Metastatic Lesions

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 7, 2018
Registry last updated
Dec 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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