Clinical trial NCT03768167: Corpectomy With Pyramesh Titanium Cage Reconstruction in Dorsolumber Metastatic Lesions
Official title: Posterolateral Corpectomy With Pyramesh Titanium Cage Reconstruction in Dorsolumber Metastatic Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Metastases
Keywords: Corpectomy
Pyramesh
Posterolateral
Pediculectomy
Facetectomies
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 26
Sex: ALL
Minimum age (years): 33
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: (Quebec scale) to assess back pain in three years
timeFrame: 3 years
measure: (muscle power grading scale) to evaluate motor power using in three years
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Ahmed Salaheldin Mohammed Saro
Study officials:
affiliation: Assuit faculty of medicine
name: Roshdy A Elkhayat, Professor of neurosurgery
role: STUDY_CHAIR
References: