Clinical trial NCT03427632: Role of Percutaneous Vertebroplasty in Treatment of Vertebral Tumors
Official title: Role of Percutaneous Vertebroplasty in Treatment of Vertebral Tumors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bone Tumor
Keywords: PVP
bone tumor
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 11
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male or female patients diagnosed with vertebral body metastasis, multiple myloma, lymphoma meet the inclusion and exclusion criteria.

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.

Eligibility criteria: 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

Primary outcomes:
measure: pain relief
timeFrame: immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University hospital
Study officials:
affiliation: Assiut University
name: Nisreen Abbas, MD
role: STUDY_CHAIR
References:
citation: 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.
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. doi: 10.1359/JBMR.041131. Epub 2004 Nov 29.
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. doi: 10.1097/00007632-200011150-00022. No abstract available.
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.