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

A

Assiut University

Status

Unknown

Conditions

Bone Tumor

Treatments

Drug: Bone Cements

Study type

Observational

Funder types

Other

Identifiers

NCT03427632
PVPfortumors

Details and patient eligibility

About

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

Full 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.

Enrollment

11 estimated patients

Sex

All

Ages

1 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

11 participants in 1 patient group

percutaneous Vertebroplasty
Description:
patients meet the inclusion and exclusion criteria will be subjected to percutaneous vertebroplasty receiving bone cement (Polymethyl methacrylate)
Treatment:
Drug: Bone Cements

Trial contacts and locations

1

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Central trial contact

mustafa saed, MSc

Data sourced from clinicaltrials.gov

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