Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232466
Status:
COMPLETED
Last Update Posted:
2018-02-15
First Post:
2005-09-30
Brief Title:
VERTOS-II Percutaneous Vertebroplasty Versus Conservative Therapy
Sponsor:
Clinical Research Office Imaging Division
Organization:
UMC Utrecht
Study Overview
Official Title:
VERTOS II Percutaneous Vertebroplasty Versus Conservative Therapy in Patients With Osteoporotic Vertebral Fractures
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Percutaneous vertebroplasty is a new procedure for treating painful osteoporotic compression fractures of the spine Five-thousand out of 12000 patients 16000 vertebral fracturesyear in the Netherlands present with sudden severe back pain in the region of the fractureUntil recently bed rest analgesia and physical support were the only treatment options After decades of performing PV no large RCT with mid-term follow-up has been published
Design
This will be a multicenter 6 centers prospective randomised intervention study Eligible patients will be randomised for percutaneous vertebroplasty or conservative therapy
Study population
Age 50 and older vertebral fracture level thoracic vertebral body 5 Th 5 or lower osteopenia T-score lt -1 SD back pain for no more than 6 weeks and edema in the vertebrae on MR imaging
Statistical analyses All analyses will be performed on an intention to treat principle The planned number of subjects will be 200 in total 100 in each intervention arm
Economic evaluation
Cost-effectiveness will be assessed The costs of the procedure and the medical treatment and of visits to medical specialists GPs and physical therapists will be compared
Time schedule
The total study will take 36 months
Recruitment of patients 200 has been completed In May 2009 the 1 year follow-up will be finished
Design
This will be a multicenter 6 centers prospective randomised intervention study Eligible patients will be randomised for percutaneous vertebroplasty or conservative therapy
Study population
Age 50 and older vertebral fracture level thoracic vertebral body 5 Th 5 or lower osteopenia T-score lt -1 SD back pain for no more than 6 weeks and edema in the vertebrae on MR imaging
Statistical analyses All analyses will be performed on an intention to treat principle The planned number of subjects will be 200 in total 100 in each intervention arm
Economic evaluation
Cost-effectiveness will be assessed The costs of the procedure and the medical treatment and of visits to medical specialists GPs and physical therapists will be compared
Time schedule
The total study will take 36 months
Recruitment of patients 200 has been completed In May 2009 the 1 year follow-up will be finished
Detailed Description:
Design
This will be a multicenter 6 centers prospective randomized intervention study Eligible patients will be randomized for percutaneous vertebroplasty or analgesics
Study populationTwo hundred patients will be included
Patient selection
Patients will be referred from the GP to the radiology department for acute back pain The GP will order an X-ray of the thoracic and lumbar spine to establish an osteoporotic vertebral fractures Subsequently the hospital radiologist will pick out the cases with vertebral fractures Subsequently the general physician geriatrician will confirm the diagnosis of osteoporotic vertebral fracture and exclude other causes of vertebral fracture eg tumour major trauma Finally the patient and their GP will be asked to participate in our study
Eligible patients will be randomized for percutaneous vertebroplasty and pain medication if necessary or only analgesics
Procedure
The treatment consists of a transpedicular injection of polymethylmethacrylate bone cement into the collapsed vertebral body maximal 2 vertebrae in 1 treatment session using fluoroscopic guidance The procedure is performed under the use of local anesthetics and the patient can be discharged the same day or after 1 night of hospital stay
Conventional treatment analgesics
The internist optimizes the use of analgesics in ascending order 1 Paracetamol 2 Tramadol 3 Tramadol and Paracetamol 4 Morphine
All patients receive osteoporosis medication
Outcome parameters
The primary outcome for the clinical study as well as the economic evaluation will be adequate relief of pain Pain intensity will be measured by means of a visual analogue scale VAS Relief of up to 30 to 44 scale points scale 0-10 is associated with a clinically relevant pain reduction Beurskens et al 1995 The main goal of the economic evaluation is to assess the balance between costs and effects of percutaneous vertebroplasty and pain medication as compared to usual care analgesics physiotherapy visits to general practitioner after 4 weeks and after 1 year
The clinical research objectives are to compare the effects 1 day1 week 1 month 3 months 6 months12 months and 24 months of vertebroplasty with conventional therapy on a back pain b activities of daily living ADL c mood d general health and e quality of life in patients with painful osteoporotic vertebral fractures Other objectives are to study the 1 and 2-year incidence of recurrent fractures especially adjacent to treated levels of
Measurements
a b c d and e are measured by using the visual analogue scale VAS for pain intensity the Roland Disability Questionnaire RDQ for functional status while the EQ6D and the Qualeffo-41 focus on quality of life mood and general health Data will be collected about units of resource utilization with an explicit clause asking whether it can be related to the vertebral fracture
New osteoporotic vertebral fractures are assessed at baseline by conventional radiography and magnetic resonance MR imaging The incidence of recurrent fractures will be determined by conventional X-rays at 1312 and 24 months
Economic evaluation
The goal of the economic evaluation is to assess the balance between costs and effects of vertebroplasty as compared to usual care
We will initially perform a cost-effectiveness analysis with a one month time horizon Given immediate pain relief in a majority after vertebroplasty already a cost-effectiveness ratio can be calculated
Estimates of other relevant outcomes such as costs and quality of life will also be entered in the model to allow a full economic evaluation We will estimate incremental costs per additional year freed of pain of immediate vertebroplasty as compared to vertebroplasty after one month and synthetic scenario of care as usual As the latter does involve extrapolation using estimates not actually observed in the trial we can not use bootstrap simulation to assess uncertainty Accordingly multivariate probabilistic sensitivity analysis Monte carlo simulations will be used to evaluate uncertainty in the cost-effectiveness ratios As we will take into account a time horizon up till one year costs nor effects will be discounted Finally a cost-utility analysis is foreseen based on utility scores obtained over the first month of observation after randomization
The direct medical costs will be estimated from a societal perspective This implies that resource use such as GP visits analgesics physiotherapy and consultation of orthopedic surgeons or general physicians will be recorded in the CRF and in patient diaries In parallel actual costs of the resources ie unit costs will be estimated The majority will be based on the estimates gathered in the Dutch guidelines for economic evaluation published by CVZ Subsequently multiplication of units costs with resource use will yield cost estimates on an individual patient level With regard to costs due to losses in productivity we pose that the majority of patients does not have a paid job Time spent by spouses family and friends taking over certain household activities or other unpaid activities will be accounted for using shadow prices
The primary outcome for the economic evaluation will be adequate relief of pain Pain will be measured by means of a visual analogue scale VAS Relief of up to 30 to 44 scale points is considered adequate Time until this outcome is attained will explicitly be accounted for in the economic evaluation
In addition to pain health related quality of life will be measured Subsequent summation over the period of follow up will yield overall QALYs up to a year for each arm of the trial
In the cost effectiveness analysis we will take care of the differences in the Belgium and Dutch healthcare system
Statistical analyzes All analyzes will be performed on an intention to treat principle In addition analyzes will on the different outcomes will be compared between the two groups with the Students t-test for continuous normally distributed variables with the Mann-Whitney test for variables that are not normally distributed and with the chi² test for categorical variables In addition subgroups eg longshot duration of complaints will be examined in which vertebroplasty has a more or less pronounced effect by introducing interaction terms in linear regression models with change in pain and quality of life as outcome variables
The one-year cumulative incidence of new fractures adjacent to the treatedold fracture levels will be compared between patients who were treated with vertebroplasty and those who were not with Cox-proportional hazards analyzes adjusting for confounders
Power calculations
The planned number of subjects will be 200 in total 100 in each intervention arm This number is based on conventional assumptions of alfa005 and ß020 withdrawal from intervention of 20 Based on pilot data and literature we expect a difference of 25 in significant pain relief If we assume that 20 withdraws from intervention we need approximately 100 patients in each group
Time schedule
The total study will take 36 months
Recruitment of patients 200 has been completed In May 2009 the 1 year follow-up will be finished
This will be a multicenter 6 centers prospective randomized intervention study Eligible patients will be randomized for percutaneous vertebroplasty or analgesics
Study populationTwo hundred patients will be included
Patient selection
Patients will be referred from the GP to the radiology department for acute back pain The GP will order an X-ray of the thoracic and lumbar spine to establish an osteoporotic vertebral fractures Subsequently the hospital radiologist will pick out the cases with vertebral fractures Subsequently the general physician geriatrician will confirm the diagnosis of osteoporotic vertebral fracture and exclude other causes of vertebral fracture eg tumour major trauma Finally the patient and their GP will be asked to participate in our study
Eligible patients will be randomized for percutaneous vertebroplasty and pain medication if necessary or only analgesics
Procedure
The treatment consists of a transpedicular injection of polymethylmethacrylate bone cement into the collapsed vertebral body maximal 2 vertebrae in 1 treatment session using fluoroscopic guidance The procedure is performed under the use of local anesthetics and the patient can be discharged the same day or after 1 night of hospital stay
Conventional treatment analgesics
The internist optimizes the use of analgesics in ascending order 1 Paracetamol 2 Tramadol 3 Tramadol and Paracetamol 4 Morphine
All patients receive osteoporosis medication
Outcome parameters
The primary outcome for the clinical study as well as the economic evaluation will be adequate relief of pain Pain intensity will be measured by means of a visual analogue scale VAS Relief of up to 30 to 44 scale points scale 0-10 is associated with a clinically relevant pain reduction Beurskens et al 1995 The main goal of the economic evaluation is to assess the balance between costs and effects of percutaneous vertebroplasty and pain medication as compared to usual care analgesics physiotherapy visits to general practitioner after 4 weeks and after 1 year
The clinical research objectives are to compare the effects 1 day1 week 1 month 3 months 6 months12 months and 24 months of vertebroplasty with conventional therapy on a back pain b activities of daily living ADL c mood d general health and e quality of life in patients with painful osteoporotic vertebral fractures Other objectives are to study the 1 and 2-year incidence of recurrent fractures especially adjacent to treated levels of
Measurements
a b c d and e are measured by using the visual analogue scale VAS for pain intensity the Roland Disability Questionnaire RDQ for functional status while the EQ6D and the Qualeffo-41 focus on quality of life mood and general health Data will be collected about units of resource utilization with an explicit clause asking whether it can be related to the vertebral fracture
New osteoporotic vertebral fractures are assessed at baseline by conventional radiography and magnetic resonance MR imaging The incidence of recurrent fractures will be determined by conventional X-rays at 1312 and 24 months
Economic evaluation
The goal of the economic evaluation is to assess the balance between costs and effects of vertebroplasty as compared to usual care
We will initially perform a cost-effectiveness analysis with a one month time horizon Given immediate pain relief in a majority after vertebroplasty already a cost-effectiveness ratio can be calculated
Estimates of other relevant outcomes such as costs and quality of life will also be entered in the model to allow a full economic evaluation We will estimate incremental costs per additional year freed of pain of immediate vertebroplasty as compared to vertebroplasty after one month and synthetic scenario of care as usual As the latter does involve extrapolation using estimates not actually observed in the trial we can not use bootstrap simulation to assess uncertainty Accordingly multivariate probabilistic sensitivity analysis Monte carlo simulations will be used to evaluate uncertainty in the cost-effectiveness ratios As we will take into account a time horizon up till one year costs nor effects will be discounted Finally a cost-utility analysis is foreseen based on utility scores obtained over the first month of observation after randomization
The direct medical costs will be estimated from a societal perspective This implies that resource use such as GP visits analgesics physiotherapy and consultation of orthopedic surgeons or general physicians will be recorded in the CRF and in patient diaries In parallel actual costs of the resources ie unit costs will be estimated The majority will be based on the estimates gathered in the Dutch guidelines for economic evaluation published by CVZ Subsequently multiplication of units costs with resource use will yield cost estimates on an individual patient level With regard to costs due to losses in productivity we pose that the majority of patients does not have a paid job Time spent by spouses family and friends taking over certain household activities or other unpaid activities will be accounted for using shadow prices
The primary outcome for the economic evaluation will be adequate relief of pain Pain will be measured by means of a visual analogue scale VAS Relief of up to 30 to 44 scale points is considered adequate Time until this outcome is attained will explicitly be accounted for in the economic evaluation
In addition to pain health related quality of life will be measured Subsequent summation over the period of follow up will yield overall QALYs up to a year for each arm of the trial
In the cost effectiveness analysis we will take care of the differences in the Belgium and Dutch healthcare system
Statistical analyzes All analyzes will be performed on an intention to treat principle In addition analyzes will on the different outcomes will be compared between the two groups with the Students t-test for continuous normally distributed variables with the Mann-Whitney test for variables that are not normally distributed and with the chi² test for categorical variables In addition subgroups eg longshot duration of complaints will be examined in which vertebroplasty has a more or less pronounced effect by introducing interaction terms in linear regression models with change in pain and quality of life as outcome variables
The one-year cumulative incidence of new fractures adjacent to the treatedold fracture levels will be compared between patients who were treated with vertebroplasty and those who were not with Cox-proportional hazards analyzes adjusting for confounders
Power calculations
The planned number of subjects will be 200 in total 100 in each intervention arm This number is based on conventional assumptions of alfa005 and ß020 withdrawal from intervention of 20 Based on pilot data and literature we expect a difference of 25 in significant pain relief If we assume that 20 withdraws from intervention we need approximately 100 patients in each group
Time schedule
The total study will take 36 months
Recruitment of patients 200 has been completed In May 2009 the 1 year follow-up will be finished
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 945-06-351 | None | None | None |