Role of Percutaneous Vertebroplasty in Treatment of Vertebral Tumors

Bone Tumor Clinical Trial

— PVP  

Official title:

Role of Percutaneous Vertebroplasty in Treatment of Vertebral Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03427632
• Other study ID #: PVPfortumors
• Status: Not yet recruiting
• Phase: N/A
• First received: January 29, 2018
• Last updated: February 3, 2018
• Start date: March 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: February 2018
• Source: Assiut University
• Contact: mustafa saed, MSc
• Phone: 01118894427
• Email: msaed9939[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 11
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Gender: All
• Age group: 1 Year to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Neoplasms
• Bone Tumor

Intervention

Drug:
• Bone Cements
patents in PVP group will get injected with bone cement inside the collapsed malignant vertebra

Locations

Country	Name	City	State
Egypt	Assiut University hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Alvarez L, Pérez-Higueras A, Quiñones 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. Epub 2003 Mar 22. — View Citation

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. Epub 2004 Nov 29. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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