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Role of Percutaneous Vertebroplasty in Treatment of Vertebral Tumors (PVP)

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ClinicalTrials.gov Identifier: NCT03427632
Recruitment Status : Not yet recruiting
First Posted : February 9, 2018
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Mustafa syd, Assiut University

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

Condition or disease Intervention/treatment
Bone Tumor Drug: Bone Cements

Detailed Description:
Destructive vertebral lesions are a common in metastatic disease, multiple myeloma and lymphoma. Symptoms are caused by pathologic fracture consequences secondary to vertebral destruction, development of spinal instability and compression of adjacent neurological elements. Nonoperative treatments include radiotherapy, hormone therapy, cytotoxic drugs which are effective to halt the osteolytic process and reverse the neurological compromise, however; they cannot provide stability or relieve pain or cord compression. Surgical management options including vertebrectomy, reconstruction with a cage or PMMA bone cement, and stabilization with pedicle screws can restore spinal canal support and neurological functions also control pain, however; usually associated with high postoperative morbidity and mortality. Also not advisable for multifocal spinal disease. Percutaneous vertebroplasty is a new technique to strengthen bone and reduce pain. It is percutaneous, minimally invasive, image-guided procedure that involves injection of radio-opaque bone cement into a partially collapsed vertebral body, in an effort to provide stability and pain relief. The exact mechanism of pain relief remains unclear. Proposed theories include more favourable biomechanics after cement strengthening, chemical toxicity and exothermic effect of cement polymerization on nerve endings.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 11 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Months
Official Title: Role of Percutaneous Vertebroplasty in Treatment of Vertebral Tumors
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Cancer

Group/Cohort Intervention/treatment
percutaneous Vertebroplasty
patients meet the inclusion and exclusion criteria will be subjected to percutaneous vertebroplasty receiving bone cement (Polymethyl methacrylate)
Drug: Bone Cements
patents in PVP group will get injected with bone cement inside the collapsed malignant vertebra
Other Name: Polymethyl methacrylate




Primary Outcome Measures :
  1. pain relief [ Time Frame: immediate ]
    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



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Ages Eligible for Study:   1 Year to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Male or female patients diagnosed with vertebral body metastasis, multiple myloma, lymphoma meet the inclusion and exclusion criteria.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427632


Contacts
Contact: mustafa saed, MSc 01118894427 msaed9939@gmail.com

Locations
Egypt
Assiut University hospital Recruiting
Assiut, Egypt, 71515
Contact: graduate studies, No    +2088 22080150    vp_grad@aun.edu.eg   
Sponsors and Collaborators
Assiut University
Investigators
Study Chair: Nisreen Abbas, MD Assiut University

Publications:
Responsible Party: Mustafa syd, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03427632     History of Changes
Other Study ID Numbers: PVPfortumors
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Mustafa syd, Assiut University:
PVP
bone tumor

Additional relevant MeSH terms:
Bone Neoplasms
Neoplasms by Site
Neoplasms
Bone Diseases
Musculoskeletal Diseases
Polymethyl Methacrylate
Vasodilator Agents
Antimutagenic Agents
Protective Agents
Physiological Effects of Drugs