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Role of Percutaneous Vertebroplasty in Treatment of Vertebral Tumors

Role of Percutaneous Vertebroplasty in Treatment of Vertebral Tumors

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03427632
Acronym
PVP
Enrollment
11
Registered
2018-02-09
Start date
2018-03-01
Completion date
2019-03-01
Last updated
2018-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Tumor

Keywords

PVP, bone tumor

Brief summary

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

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.

Interventions

DRUGBone Cements

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 100 Years

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

Design outcomes

Primary

MeasureTime frameDescription
pain reliefimmediatereduction 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

Countries

Egypt

Contacts

Primary Contactmustafa saed, MSc
msaed9939@gmail.com01118894427

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026