Corpectomy With Pyramesh Titanium Cage Reconstruction in Dorsolumber Metastatic Lesions
Primary Purpose
Spinal Metastases
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Posterolateral corpectomy
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Metastases focused on measuring Corpectomy, Pyramesh, Posterolateral, Pediculectomy, Facetectomies
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.
Sites / Locations
- Ahmed Salaheldin Mohammed Saro
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
patients with metastatic spinal lesions
Arm Description
corpectomy
Outcomes
Primary Outcome Measures
(Quebec scale) to assess back pain in three years
(Quebec Scale) the lower scale the better is the pain
(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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03768167
Brief Title
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
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2014 (Actual)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
August 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Metastases
Keywords
Corpectomy, Pyramesh, Posterolateral, Pediculectomy, Facetectomies
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients with metastatic spinal lesions
Arm Type
Other
Arm Description
corpectomy
Intervention Type
Procedure
Intervention Name(s)
Posterolateral corpectomy
Intervention Description
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 Outcome Measure Information:
Title
(Quebec scale) to assess back pain in three years
Description
(Quebec Scale) the lower scale the better is the pain
Time Frame
3 years
Title
(muscle power grading scale) to evaluate motor power using in three years
Description
(Muscle power grading) the higher the grade the better is the motor power
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
33 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roshdy A Elkhayat, Professor of neurosurgery
Organizational Affiliation
Assuit faculty of medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Ahmed Salaheldin Mohammed Saro
City
Sohag
ZIP/Postal Code
82511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Corpectomy With Pyramesh Titanium Cage Reconstruction in Dorsolumber Metastatic Lesions
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