NCT03427632

Brief Summary

Percutaneous vertebroplasty is a new technique to strengthen bone and reduce pain for patients with vertebral tumors

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

January 29, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

February 9, 2018

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

January 29, 2018

Last Update Submit

February 3, 2018

Conditions

Bone Tumor

Keywords

PVPbone tumor

Outcome Measures

Primary Outcomes (1)

  • pain relief

    reduction of spine pain following the injection of bone cement in the tumor according to Numeric Rating Scale, Improvement will be considered if NRS score decrease ≧ 20% after PVP

    immediate

Study Arms (1)

percutaneous Vertebroplasty

patients meet the inclusion and exclusion criteria will be subjected to percutaneous vertebroplasty receiving bone cement (Polymethyl methacrylate)

Drug: Bone Cements

Interventions

Bone CementsDRUG

patents in PVP group will get injected with bone cement inside the collapsed malignant vertebra

Also known as: Polymethyl methacrylate
percutaneous Vertebroplasty

Eligibility Criteria

Age1 Year - 100 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Male or female patients diagnosed with vertebral body metastasis, multiple myloma, lymphoma meet the inclusion and exclusion criteria.

You may qualify if:

  • Spinal instability
  • Pain with movement
  • Multiple level involvement
  • Expected survival 3-6 months

You may not qualify if:

  • Absolute
  • Asymptomatic
  • improving on medical treatment without worsening of the collapse.
  • infection local or systemic
  • uncorrectable coagulopathy
  • Allergy to bone cement or contrast media
  • Relative
  • Radicular pain
  • Tumor extension inside the vertebral canal or cord compression
  • Fracture of the posterior column
  • Sclerotic metastasis
  • Diffuse metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University hospital

Asyut, 71515, Egypt

Location

Related Publications (4)

  • Alvarez L, Perez-Higueras A, Quinones D, Calvo E, Rossi RE. Vertebroplasty in the treatment of vertebral tumors: postprocedural outcome and quality of life. Eur Spine J. 2003 Aug;12(4):356-60. doi: 10.1007/s00586-003-0525-z. Epub 2003 Mar 22.

    PMID: 12687441BACKGROUND

  • Melton LJ 3rd, Kyle RA, Achenbach SJ, Oberg AL, Rajkumar SV. Fracture risk with multiple myeloma: a population-based study. J Bone Miner Res. 2005 Mar;20(3):487-93. doi: 10.1359/JBMR.041131. Epub 2004 Nov 29.

    PMID: 15746994BACKGROUND

  • Wenger M, Markwalder TM. Re: Percutaneous vertebroplasty for pain relief and spinal stabilization (Spine 2000; 25: 923-8). Spine (Phila Pa 1976). 2000 Nov 15;25(22):2968-9. doi: 10.1097/00007632-200011150-00022. No abstract available.

    PMID: 11074686BACKGROUND

  • Tsoumakidou G, Too CW, Koch G, Caudrelier J, Cazzato RL, Garnon J, Gangi A. CIRSE Guidelines on Percutaneous Vertebral Augmentation. Cardiovasc Intervent Radiol. 2017 Mar;40(3):331-342. doi: 10.1007/s00270-017-1574-8. Epub 2017 Jan 19.

    PMID: 28105496BACKGROUND

MeSH Terms

Conditions

Bone Neoplasms

Interventions

Bone CementsPolymethyl Methacrylate

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Resins, SyntheticPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsSpecialty Uses of ChemicalsChemical Actions and UsesManufactured MaterialsTechnology, Industry, and AgricultureMethylmethacrylatesPolymethacrylic AcidsAcrylatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAcrylic Resins

Study Officials

  • Nisreen Abbas, MD

    Assiut University

    STUDY CHAIR

Central Study Contacts

mustafa saed, MSc

CONTACT

01118894427msaed9939@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 29, 2018

First Posted

February 9, 2018

Study Start

March 1, 2018

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

February 9, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)