Role of Percutaneous Vertebroplasty in Treatment of Vertebral Tumors

NCT ID: NCT03427632

Last Updated: 2018-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-03-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Bone Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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percutaneous Vertebroplasty

patients meet the inclusion and exclusion criteria will be subjected to percutaneous vertebroplasty receiving bone cement (Polymethyl methacrylate)

Bone Cements

Intervention Type DRUG

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

Interventions

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Bone Cements

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

Intervention Type DRUG

Other Intervention Names

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Polymethyl methacrylate

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mustafa syd

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nisreen Abbas, MD

Role: STUDY_CHAIR

Assiut University

Locations

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Assiut University hospital

Asyut, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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mustafa saed, MSc

Role: CONTACT

01118894427

Facility Contacts

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graduate studies, No

Role: primary

+2088 22080150

References

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Alvarez L, Perez-Higueras A, Quinones 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. doi: 10.1007/s00586-003-0525-z. Epub 2003 Mar 22.

Reference Type BACKGROUND
PMID: 12687441 (View on PubMed)

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. doi: 10.1359/JBMR.041131. Epub 2004 Nov 29.

Reference Type BACKGROUND
PMID: 15746994 (View on PubMed)

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. doi: 10.1097/00007632-200011150-00022. No abstract available.

Reference Type BACKGROUND
PMID: 11074686 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28105496 (View on PubMed)

Other Identifiers

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PVPfortumors

Identifier Type: -

Identifier Source: org_study_id

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