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Percutaneous Vertebroplasty Versus Conservative Treatment in GIOPVCF

NCT03330340 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 106

Last updated 2017-11-06

No results posted yet for this study

Summary

Based on the case reports and other literature, the investigators hypothesize that using PVP for treating GIOPVCF is associated with increased risk of vertebral refractures and does not provide further benefits compared to conservative treatments.

The overall objective of this prospective cohort study is to compare the efficacy of PVP and conservative treatment for GIOPVCF. The evaluation of efficacy of therapy includes: 1) the incidence of vertebral refractures; 2) therapeutic effects (pain relief and health-related life quality) and 3) complications.

The results from study will be written in English and disseminated widely through scholarly presentations, peer-reviewed publications, and other written communications.

Conditions

Interventions

PROCEDURE

Percutaneous Vertebroplasty

The procedure takes place under sterile conditions. Local anesthesia is administered from skin to the periosteum of the targeted pedicle. Polymethylmethacrylate bone cement (Mendec Spine; Tecres SPA, Sommacampagna, Italy) is injected under continuous fluoroscopic imaging guidance using 1.0 ml syringes and 13 Gauge bone biopsy needles by bilateral procedures. The amount of injected cement in each treated vertebral body and any cement leakage is recorded.

Sponsors & Collaborators

  • Peking University First Hospital

    lead OTHER

Principal Investigators

  • Chunde Li, Doctor · Peking University First Hospital

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2019-12-30
Completion
2019-12-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03330340 on ClinicalTrials.gov