Role of Percutaneous Vertebroplasty in Treatment of Vertebral Tumors

• Conditions: Bone Tumor
• Interventions: Drug: Bone Cements

• Registration Number: NCT03427632
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2018-01-29
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-03
• Last Update Submitted: 2018-02-03
• Study First Posted: 2018-02-09
• Last Update Posted: 2018-02-09
• Study Start: 2018-03-01
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
pain relief	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

Trial Locations

Locations (1)

Assiut University hospital; 🇪🇬 Assiut, Egypt