A Study of Kyphoplasty and Vertebroplasty in the Treatment of Spine Metastases

Study Overview
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Brief Summary
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Conventional vertebroplasty is an effective option in the treatment of bone lesions (osteoporotic and neoplastic). It is indicated as an analgesic treatment and aims at reinforcing a compressed vertebrae or at risk of fracture. The main adverse event related to vertebroplasty use is the cement leakages that might be responsible for significant clinical impairments. Kyphoplasty is a recent alternative strategy of vertebroplasty, based on the insertion on balloon through the needle into the targeted vertebrae and then inflation of the balloon prior to cement injection into the space. In an osteoporotic setting, kyphoplasty allow reducing the incidence of cement leakage. To date, no data from randomized study are available in the population of cancer patients.

Official Title
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A Randomized, Multicenter, Open-label, Bayesian-based Phase II Study of the Feasibility of Kyphoplasty in the Local Treatment of Spine Metastases From Solid Tumors

Conditions
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Solid Tumors, Spine Metastasis

Intervention / Treatment
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* Device: Kyphoplasty
* Device: Conventional vertebroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of cancer other than malignant hemopathies, myeloma, brain tumors, germ-cell tumors and bone sarcomas; 2 metastatic sites or more; Spine metastasis between T1 and L5 with reduction of vertebrae of 20% at least; Indication of cementoplasty of 1 to 6 vertebrae defined by 1 of the following: Pain equal or greater than 4/10 at Visual Analogic Scale Unstable vertebrae (SINS score equal or greater than 7; Performance Status of the Eastern Cooperative Oncology Group : 0, 1 or 2 Exclusion Criteria: Contraindication to vertebroplasty, including contraindication to cement use; Patient already treated by vertebroplasty within the past 3 months (1 patient can not be allocated twice in this study); Previous focal treatment of the targeted vertebrae (vertebroplasty, percutaneous radiofrequency, embolization); Neurological deficit due to medullar or radicular compression; Participation to another clinical trial with an analgesic intent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional vertebroplasty<br>Conventional vertebroplasty (device's trade at the discretion of the investigator) | Device: Conventional vertebroplasty<br>* Conventional vertebroplasty<br>* Other names: Vertebroplasty;|
| Experimental: Kyphoplasty<br>Vertebroplasty with balloon placement and inflation prior to cement injection (device's trade at the discretion of the investigator) | Device: Kyphoplasty<br>* Placement and inflation of balloon prior to cement injection<br>* Other names: Balloon kyphoplasty;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate for each strategy | The success rate will be calculated with the proportion of patients without cement leakage | 3 months after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height of the targeted vertebrae |  | 3 months after the procedure | 
| Height of the patient |  | 3 months after the procedure | 
| Kyphotic angle |  | 3 months after the procedure | 
| Analgesic properties of the strategies the day after the procedure | Pain will be assessed using a Visual Analogic Scale | The day after the procedure | 
| Analgesic properties of the strategies at 21 days | Pain will be assessed using a Visual Analogic Scale | 21 days after the procedure | 
| Analgesic properties of the strategies at the end of the study | Pain will be assessed using a Visual Analogic Scale | 3 months after the procedure | 
| Tolerance profile of the strategies | Tolerance will be evaluated according to the National Cancer Institute - Common Terminology Criteria Adverse Event grading scale version 4 | Through study completion | 
| Type of cement leakage (vascular versus cortical localisation) | Location will be described as vascular or cortical using the imaging assessments | 3 months after the procedure | 
| Size of cement leakage | Size will be described as significant or not significant as per investigator judgement | 3 months after the procedure | 
| Symptoms associated with cement leakage | Symptoms associated with cement leakage will be tolerance events that are stated by the investigator as related to a cement leakage | 3 months after the procedure | 
| Quality of Life in both arms at Day 21 | Quality of Life will be assessed with the Dallas questionnaire for spinal pain | 21 days after procedure | 
| Quality of Life in both arms at the end oh study | Quality of Life will be assessed with the Dallas questionnaire for spinal pain | 3 months after the procedure | 
| Correlation between volume of cement injected and the level of pain relief using the Visual Analogic Scale |  | 3 months after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solid tumors, Spine metastasis, Vertebroplasty, kyphoplasty, randomization