Corpectomy With Pyramesh Titanium Cage Reconstruction in Dorsolumber Metastatic Lesions

NCT03768167 | Completed

• 1 other identifier: Sohag2
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Metastases

Keywords

Corpectomy; Pyramesh; Posterolateral; Pediculectomy; Facetectomies

Outcome Measures

Primary Outcomes (2)

• (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

Study Arms (1)

patients with metastatic spinal lesions

OTHER

corpectomy

Procedure: Posterolateral corpectomy

Interventions

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.

patients with metastatic spinal lesions

Eligibility Criteria

• Age: 33 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with retropulsed fragment inside the canal that causes spinal cord compression with neurological manifestation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Ahmed Salaheldin Mohammed Saro

Sohag, 82511, Egypt

Location

Study Officials

• Roshdy A Elkhayat, Professor of neurosurgery

  Assuit faculty of medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of neurosurgery

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 7, 2018
• Study Start: August 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: December 10, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)