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The purpose of this study is to compare the effect of vertebroplasty with that of traditional medical treatment in the treatment of painful vertebral fractures in osteoporotic patients.
In vertebroplasty a bone cement is injected in one or more fractured vertebra. The indication is pain that needs high doses of analgesics.
The cement is a well known product called poly methyl metacrylate (PMMA) normally used fixate joint prosthesis.
Vertebroplasty is done in local anaesthesia. The treatment was introduced in 1984 in France and today thousands of patients have been treated worldwide, but so far no randomized controlled trials have been published.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Poly methylmetacrylate, PMMA | Genetic |
| Measure | Description | Time Frame |
|---|---|---|
| Level of pain | before treatment and day 1, day 3, day 10 and after 1, 3, 6 and 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Needs for analgetics, number of days at hospital, level of ADL | before treatment and day 1, day 3, day 10 and after 1, 3, 6 and 12 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leif Sorensen, Consultant | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep of Neuroradiology, Aarhus University Hospital | Aarhus | DK 8000 | Denmark |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D010024 | Osteoporosis |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001851 | Bone Diseases, Metabolic |
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| ID | Term |
|---|---|
| D019904 | Polymethyl Methacrylate |
| ID | Term |
|---|---|
| D008768 | Methylmethacrylates |
| D011109 | Polymethacrylic Acids |
| D000179 | Acrylates |
| D000144 | Acids, Acyclic |
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| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014947 | Wounds and Injuries |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000180 | Acrylic Resins |
| D012117 | Resins, Synthetic |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |