Percutaneous Vertebroplasty Versus Conservative Treatment in GIOPVCF
NCT ID: NCT03330340
Last Updated: 2017-11-06
Study Results
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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UNKNOWN
106 participants
OBSERVATIONAL
2017-12-01
2019-12-30
Brief Summary
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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.
Detailed Description
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The general information and medicine history of the participants are collected: age, gender, original disease, the course of original disease, specific GCs that have been used, the dosage/length of the GCs treatment, specific anti-osteoporosis medicine have been used and the dosage and length of usage. The bone density of the patient will then be evaluated using Dual-energy X-ray absorptiometry (DXA).
Withdrawal of individual subject Patients can withdraw from the study at any time for any reason without any consequences. The investigator can also decide to release patients from the study for medical reasons. For every patient who decides to withdraw from the study, the reasons of withdrawal will be recorded.
Sample size calculation A p-value is less than significance level (α) of 0.05 is considered as statistically significant. The statistical power (1-β) is defined as 80%. Based on the survival analysis of primary endpoint , the incidence of refracture in the patients with GIOPVCF is 48.6% after initial PVP operation and 17% after initial conservative treatment. Thus, power analysis indicates the study requires 42 patients per group to achieve statistical significance between two groups. Considering 20% of patients may be lost during follow-up visits, the investigators will recruit 53 patients for each group.
Statistical analysis Standard statistical techniques will be used to describe characteristics of patients in both groups. The investigators will compare baseline characteristics in the two treatment groups and if incomparability appears, the investigators will in secondary analysis adjust for differences. The incidence of vertebral refracture between groups will be compared with the Kaplan Meier survival analysis. Baseline differences of pain relief and health-related life quality between two groups will be assessed using student t test or nonparametric tests. Changes of VAS, ODI, and EQ-5D within the group from baseline to every follow-up time point will be compared using paired t test. A P value less than 0.05 is considered as statistically significant. SPSS 17.0 statistical program (SPSS, Chicago, IL) will be used for statistical analysis.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Percutaneous vertebroplasty
All PVPs are performed by experienced spine surgeons under optimal fluoroscopic guidance. The procedure takes place under sterile conditions. Local anesthesia is administered to the periosteum of the targeted pedicle via skin. Polymethylmethacrylate bone cement is injected under continuous fluoroscopic guidance using 1.0 ml syringes and 13 Gauge bone biopsy needles by bilateral procedures. Patients are encouraged to stand up and walk with brace immediately after operation and the brace are required to be worn for 3 months. Furthermore, all patients will take oral bisphosphonates treatment together with supplemental calcium and vitamin D.
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.
Conservative treatment
In conservative treatment group, the patients were required horizontal bed rest for the initial 2 weeks after diagnosis. Then, they were encouraged to stand up and walk with brace and assistance. The bed rest time was extended if the back pain worsened when they stood up and walked. The brace should be worn in 3 months. For pain medication, nonsteroidal anti-inflammatory drugs (NSAIDs) were prescribed for every patient. Additional analgesics, such as tramadol and morphine, would be added in case NSAIDs were not effective. Two weeks after diagnosis, physical therapy was started. All patients are put on osteoporosis medication, bisphosphonates together with supplemental calcium and vitamin D.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Patients have back pain for 6 weeks or less, with a visual analogue scale (VAS) score equal or less than 5.
3. GCs consumption for more than 3 months (prednisone equivalent or more than 5 mg daily).
4. Reduced bone density with T-scores equal or less than -1.
5. Age at 55 or higher.
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Exclusion Criteria
2. Previous PVP procedure or other spinal surgery on thoracic or lumbar segments.
3. Systemic or local infection in spine (osteomyelitis, spondylodiscitis)
4. Unable to comply with study due to severe psychosis.
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55 Years
75 Years
ALL
No
Sponsors
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Peking University First Hospital
OTHER
Responsible Party
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Haolin Sun
Clinical Professor
Principal Investigators
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Chunde Li, Doctor
Role: STUDY_DIRECTOR
Peking University First Hospital
Central Contacts
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Other Identifiers
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HSun-1
Identifier Type: -
Identifier Source: org_study_id