NCT06117475

Brief Summary

To analyze the short-term outcomes of posterior corpectomy of patients with thoracolumbar spinal metastasis in spine unit in Assiut University hospital regarding the pain control , neurological status , complication and ambulatory status as well as mortality rate.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

October 2, 2023

Last Update Submit

November 2, 2023

Conditions

Spine Metastases

Outcome Measures

Primary Outcomes (1)

  • Quality of patient life postoperatively

    Measure quality of life postoperatively by mobility, self care , usual activity ( e.g work, study, housework ) , pain /discomfort and anxiety and depression by 5Q-ED score ( EUROQOL EUROQOL 5 Dimension 5 levels ). EQ-5D-5L profile data can be summarised in the same way. 11111 again means no problem on any of the five dimensions of health and the worst health state is 55555. 1 means no problem , 5 means unable to do

    5Q-ED score through complete the study about 1to 1.5 years

Interventions

Posterior corpectomyPROCEDURE

Removal of posterior portion of vertebrae by posterior approach

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient diagnosed as a spinal metastatsis

You may qualify if:

  • Patients \> 18 years old Patient diagnosed as cancer Intractable pain Progressive neurologic comprise Radioresistant tumors
  • Failure of radiotherapy
  • Failure of chemotherapy
  • Fit for surgery

You may not qualify if:

  • Patient younger 18 years old spinal 1ry tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Maccauro G, Spinelli MS, Mauro S, Perisano C, Graci C, Rosa MA. Physiopathology of spine metastasis. Int J Surg Oncol. 2011;2011:107969. doi: 10.1155/2011/107969. Epub 2011 Aug 10.

    PMID: 22312491BACKGROUND

  • Algra PR, Heimans JJ, Valk J, Nauta JJ, Lachniet M, Van Kooten B. Do metastases in vertebrae begin in the body or the pedicles? Imaging study in 45 patients. AJR Am J Roentgenol. 1992 Jun;158(6):1275-9. doi: 10.2214/ajr.158.6.1590123.

    PMID: 1590123BACKGROUND

  • Mundy GR. Metastasis to bone: causes, consequences and therapeutic opportunities. Nat Rev Cancer. 2002 Aug;2(8):584-93. doi: 10.1038/nrc867.

    PMID: 12154351BACKGROUND

  • Lau D, Chou D. Posterior thoracic corpectomy with cage reconstruction for metastatic spinal tumors: comparing the mini-open approach to the open approach. J Neurosurg Spine. 2015 Aug;23(2):217-27. doi: 10.3171/2014.12.SPINE14543. Epub 2015 May 1.

    PMID: 25932599BACKGROUND

  • Bilsky MH, Lis E, Raizer J, Lee H, Boland P. The diagnosis and treatment of metastatic spinal tumor. Oncologist. 1999;4(6):459-69.

    PMID: 10631690BACKGROUND

  • Gruenberg M, Mereles ME, Willhuber GOC, Valacco M, Petracchi MG, Sola CA. Usefulness of Tokuhashi Score in Survival Prediction of Patients Operated for Vertebral Metastatic Disease. Global Spine J. 2017 May;7(3):260-265. doi: 10.1177/2192568217699186. Epub 2017 Apr 11.

    PMID: 28660109BACKGROUND

  • Lin B, Chen ZW, Guo ZM, Liu H, Yi ZK. Anterior Approach Versus Posterior Approach With Subtotal Corpectomy, Decompression, and Reconstruction of Spine in the Treatment of Thoracolumbar Burst Fractures: A Prospective Randomized Controlled Study. J Spinal Disord Tech. 2012 Aug;25(6):309-317. doi: 10.1097/BSD.0b013e3182204c53.

    PMID: 21637134BACKGROUND

Study Officials

  • Mohammed Gamal, Professor

    Assiut University

    PRINCIPAL INVESTIGATOR

  • Essam Elmorshidy, MD

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rehab Ma Ahmed, Resident

CONTACT

01025345048rehabmahmoud@med.aun.edu.eg

Mohammed Ga Hassan, Professor

CONTACT

01001843084m.gamal@aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assiut lecturer

Study Record Dates

First Submitted

October 2, 2023

First Posted

November 7, 2023

Study Start

November 1, 2023

Primary Completion

November 1, 2024

Study Completion

December 1, 2024

Last Updated

November 7, 2023

Record last verified: 2023-11