Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Stryker Medical | INDUSTRY |
| Medtronic | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Background The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally invasive technique, is a relatively new treatment option. Recent randomized controlled trials (RCT) provide conflicting results: two sham-controlled studies showed no benefit of PV while an unmasked but controlled RCT (VERTOS II) found effective pain relief at acceptable costs in patients with acute VCFs. A still ongoing masked RCT (VERTOS IV) focuses on acute VCFs defined as โค 6 weeks. VERTOS III focused on conservative treatment and found that half of patients still had disabling pain after 3 months or longer. These patients with sustained pain after 3 months may benefit from PV.
Objective To compare pain relief after PV with a sham intervention in selected patients with a chronic osteoporotic VCF ( three months or longer) using the same strict inclusion criteria as in VERTOS II an IV. Secondary outcome measures are back pain related disability and quality of life.
Methods The VERTOS V study is a prospective RCT with pain relief as primary endpoint. Inclusion criteria are a VCF of thoracic level 5 or lower with focal tenderness at fracture level, assessed by an internist on physical examination and a Visual Analogue Scale (VAS) score โฅ 5 for three months or longer, decreased bone density defined as T score โค -1 and age 50 years or older. 94 patients will be included, 47 in each arm. Crossovers are not allowed. Follow-up is at regular intervals during one year period with VAS score for pain as primary endpoint. Secondary endpoints are back pain related disability and quality of life measured with the Quality of Life Questionnaire of the European Foundation for Osteoporosis and physical function measured with the Roland Morris Disability questionnaire.
Conclusion Vertos V is a methodologically sound masked randomised sham controlled trial of vertebroplasty in patients with sustained pain 3 months or longer after a vertebral compression fracture.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| percutaneous vertebroplasty | Active Comparator | Using fluoroscopic guidance, the practitioner infiltrates the skin and subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae with 1% lidocaine and infiltrates the periosteum of the pedicles with 0.25% bupivacaine (marcaine). For the vertebroplasty procedure, 11-gauge or 13-gauge needles are passed into the central aspect of the target vertebra or vertebrae. Bone cement (PMMA) is prepared on the bench and injected under constant fluoroscopy into the vertebral body. Injection is stopped when the cement reaches to the posterior aspect of the vertebral body or leaks into an extraosseous space, such as the intervertebral disk or an epidural or paravertebral vein. |
|
| Sham procedure | Sham Comparator | Using fluoroscopic guidance, the practitioner infiltrates the skin and subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae with 1% lidocaine and infiltrates the periosteum of the pedicles with 0.25% bupivacaine (marcaine). During the sham intervention, verbal and physical cues, such as pressure on the patient's back, are given, and the bone cement(PMMA) is prepared to simulate the odor associated with mixing of polymethacrylate , but the needle is not placed and cement is not injected. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| percutaneous vertebroplasty | Device | Using fluoroscopic guidance, the practitioner infiltrates the skin and subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae with 1% lidocaine and infiltrates the periosteum of the pedicles with 0.25% bupivacaine (marcaine. For the vertebroplasty procedure, 11-gauge or 13-gauge needles are passed into the central aspect of the target vertebra or vertebrae. Bone cement is prepared on the bench and injected under constant fluoroscopy into the vertebral body. Injection is stopped when the PMMA reaches the posterior aspect of the vertebral body or leaks into an extraosseous space, such as the intervertebral disk or an epidural or paravertebral vein. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain relief | Primary outcome will be pain score at 1 day, 1 week, and 1,3, 6 and 12 months after PV compared to baseline pain score. The questionnaire consist of the VAS score and questions about use of pain medication, pain location, and pain type. Other medical treatment and visits to alternative medical specialists, GP's and physical therapists are recorded and compared between groups. Patients are asked to fill out the VAS score and use of analgesics is recorded on a daily basis during the first month after randomization. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Back pain related disability | Back pain related disability as measured with the Roland Morris Disability (RMD) Questionnaire. The Qualeffo is developed specifically for patients with osteoporosis. This questionnaire consists of 41 questions about: pain, physical function, social function, general health perception, and mental function. The RMD questionnaire is a disability questionnaire that measures the functional status of patients with back pain. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dennis Carli, drs | Elisabeth Tweesteden Ziekenhuis/ SJG Weert | Principal Investigator |
| Paul Lohle, dr. | Elisabeth-TweeSteden Ziekenhuis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elisabeth Tweesteden Ziekenhuis | Tilburg | 5022 GC | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37462495 | Derived | Carli D, Venmans A, Lodder P, Donga E, van Oudheusden T, Boukrab I, Schoemaker K, Smeets A, Schonenberg C, Hirsch J, de Vries J, Lohle P. Vertebroplasty versus Active Control Intervention for Chronic Osteoporotic Vertebral Compression Fractures: The VERTOS V Randomized Controlled Trial. Radiology. 2023 Jul;308(1):e222535. doi: 10.1148/radiol.222535. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D016103 | Spinal Fractures |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Sham procedure | Procedure | Using fluoroscopic guidance, the practitioner infiltrates the skin and subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae with 1% lidocaine and infiltrates the periosteum of the pedicles with 0.25% bupivacaine (marcaine). During the sham intervention, verbal and physical cues, such as pressure on the patient's back, are given, and the methacrylate monomer (PMMA) is opened to simulate the odor associated with mixing of cement, but the needle is not placed and cement is not injected. |
|
| 0, 1day, 1 week, 1,3,6,12 months |
| Quality of Life | QOL as measured with the Questionnaire of the European Foundation for Osteoporosis (Qualeffo). The Qualeffo is developed specifically for patients with osteoporosis. This questionnaire consists of 41 questions about: pain, physical function, social function, general health perception, and mental function. The Qualeffo score ranges from 0 (best quality of life) to 100 (worst quality of life). This questionnaire will be completed at five measurement moments (before and at 1, 3, 6, and 12 months after the procedure). | 1 week, 1,3,6,12 months |
| D009750 |
| Nutritional and Metabolic Diseases |
| D013124 | Spinal Injuries |
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |