Vertebral Compression FracturesVITTANCT02370628
Vertebroplasty In The Treatment Of Acute Fracture Trial - The VITTA Trial
A study testing Percutaneous vertebroplasty and Facet block in people with Vertebral Compression Fractures, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
The VITTA trial is a randomized, controlled, single-blinded, cross-over trial comparing percutaneous vertebroplasty with facet block in patients with acute (<1month) and painful vertebral compression fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertebral Compression Fractures
- What is being tested?
- Percutaneous vertebroplasty and Facet block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- 17 Apr 2015to 5 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Presence of:
- at least one and at most two acute VCF (< 6 weeks) at levels caudate to T4, confirmed with physical examination and radiographic imaging
- if timing of the fracture is unclear, the following criteria are required for inclusion in the trial
- an MRI scan showing edema at the fracture level(s) or
- a bone scan showing increased uptake
- Physical examination showing axial back pain likely secondary to the VCF with restricted mobilization (score not maximum on any one of the following Barthel's Index items: transfer, mobility, bathing, dressing, stairs and toilet use)
- French or English speaking patient willing to return for follow-up or capable of following up with phone interviews if needed
Who cannot join
- Recent (<30 days) major surgery causing debilitating pain
- Coagulopathy or thrombocytopenia precluding interventional treatment
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2L 4M1
About this study
Official title: Vertebroplasty In The Treatment Of Acute Fracture Trial (The VITTA Trial)
The VITTA trial is a randomized, controlled, single-blinded, cross-over trial comparing percutaneous vertebroplasty with facet block in patients with acute (<1month) and painful vertebral compression fractures.
The treatment offered for vertebral compression fractures (VCFs) in the interventional arm of the trial is vertebroplasty, which will be performed in accordance with the standardized protocol of the Canadian Association of Radiologists. Patients in the control arm will receive facet block, where a long-acting local anesthetic agent and corticosteroids are injected in the spinal articular facets at the affected level.
Read the detailed description
Vertebroplasty is a procedure used to stabilize broken vertebrae, the bones that form the spine. This study will evaluate the effectiveness of vertebroplasty for the treatment of acute vertebral fractures.
The VITTA trial is a randomized, controlled, single-blinded, cross-over trial comparing percutaneous vertebroplasty with facet block in patients with acute (<1 month) and painful vertebral compression fractures.
Vertebral compression fractures (VCFs) frequently result in debilitating pain, impaired functional status and bad quality of life. Percutaneous vertebroplasty (PV) is a treatment for VCFs originally developed in France in the late 1980s and first performed in America in the mid-1990s. The procedure involves percutaneous application of bone cement (polymethylmethacrylate) into collapsed vertebrae.
VCFs are a significant public health problem with approximately 750,000 new fractures occurring in the United States each year, a number that is projected to rise as the population ages. In fact, one quarter of adults over the age of 50 will suffer at least one VCF in their lifetime. VCFs cause short term and occasionally long-term pain and disability, and although not immediately life threatening, they are associated with long term mortality. Before the advent of PV, the treatment for VCFs was limited to medical therapy- addressing the pain associated with the fracture but not the fracture itself thus making VCFs practically the only skeletal fracture not treated with orthopedic surgery. Since the introduction of vertebroplasty, over 800 papers, technical notes, and reviews that address this technique have been published with the overwhelming majority reporting significant pain relief and advocating the adoption of the procedure into common practice. Unfortunately, most of these studies had low evidence level and poor scientific design until randomized clinical trials were published in 2009.
Vertebroplasty for refractory back pain (after a period of conservative management of 1 month) constituted the main indication in the overwhelming majority of studies published so far. Although those studies have largely suggested that it does not offer significant improvement in pain or functional status relative to medical therapy or infusion of local anesthesia after this acute phase, the data remains inconclusive and of poor scientific quality. The present study proposes a different rationale: the benefits of vertebroplasty may be occurring in the acute phase (before 1 month) by providing immediate pain relief to the patient, hence allowing early mobilization and preventing medical complications associated with bed rest. In other terms, vertebroplasty may be a first line, acute phase treatment. If the investigators hypothesis holds true, an adequately powered clinical trial may provide sufficient evidence to change the medical indications for vertebroplasty.
- Conditions
- Vertebral Compression Fractures
- Being tested
- Percutaneous vertebroplasty, Facet block
- Keywords
- percutaneous vertebroplasty, facet block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous vertebroplastyProcedure or surgery
The procedure involves percutaneous application of bone cement (polymethylmethacrylate) into collapsed vertebrae, and has been used for treatment of patients with osteoporosis who have severe or prolonged pain following vertebral compression fracture, as well as those with painful, aggressive hemangiomas and osteolytic neoplasms.
In our trial, vertebroplasty shall be performed in two steps:
- Step 1: facet block
- Step 2: cement infusion
Therefore, patients in both arms will undergo Step 1 since our control intervention serves as a routine first part of our active intervention.
Facet blockProcedure or surgery
A long-acting local anesthetic agent and corticosteroids are injected in the spinal articular facets at the affected level.
All patients will undergo facet block since it serves as a routine first part to percutaneous vertebroplasty.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous vertebroplasty (PV) | Experimental | The procedure involves percutaneous application of bone cement (polymethylmethacrylate) into collapsed vertebrae. Receives: Procedure: Percutaneous vertebroplasty; Procedure: Facet block |
| Facet block | Active comparator | injection of anti-inflammatory and analgesic drugs Receives: Procedure: Facet block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieving a score of 75 or higher on the Barthel Index functional evaluation score
Measured: 30 days after treatment
Secondary outcomes (3)
Rate of cross-over to the alternative treatment
Measured: 15 days after treatment
Level of pain as measured by the visual analogue pain scale
Measured: at 15 days and 30 days
Proportion of patients located at home
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study start17 Apr 2015
- Primary completion5 Jun 2018
- Study completion5 Jun 2018
Why it stopped: too few participants enrolled and few interested patients in three years
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Vertebral Compression FracturesStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Raymond, MD, Principal investigator, CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370628
- Sponsor's protocol ID
- CE14.334
- Acronym
- VITTA
- Status last verified
- Jun 2018
- First submitted
- 9 Feb 2015
- Last updated
- 14 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bourgoin P, Weill A, Tampieri D. CAR Standard for Performance of the Percutaneous Vertebroplasty. Can Assoc Radiol. 2002;(March).
Kallmes DF, Comstock BA, Heagerty PJ, Turner JA, Wilson DJ, Diamond TH, Edwards R, Gray LA, Stout L, Owen S, Hollingworth W, Ghdoke B, Annesley-Williams DJ, Ralston SH, Jarvik JG. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. 2009 Aug 6;361(6):569-79. doi: 10.1056/NEJMoa0900563.
PubMed 19657122Buchbinder R, Osborne RH, Ebeling PR, Wark JD, Mitchell P, Wriedt C, Graves S, Staples MP, Murphy B. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. 2009 Aug 6;361(6):557-68. doi: 10.1056/NEJMoa0900429.
PubMed 19657121Comstock BA, Sitlani CM, Jarvik JG, Heagerty PJ, Turner JA, Kallmes DF. Investigational vertebroplasty safety and efficacy trial (INVEST): patient-reported outcomes through 1 year. Radiology. 2013 Oct;269(1):224-31. doi: 10.1148/radiol.13120821. Epub 2013 May 21.
PubMed 23696683Voormolen MH, Mali WP, Lohle PN, Fransen H, Lampmann LE, van der Graaf Y, Juttmann JR, Jansssens X, Verhaar HJ. Percutaneous vertebroplasty compared with optimal pain medication treatment: short-term clinical outcome of patients with subacute or chronic painful osteoporotic vertebral compression fractures. The VERTOS study. AJNR Am J Neuroradiol. 2007 Mar;28(3):555-60.
PubMed 17353335Do HM, Kim BS, Marcellus ML, Curtis L, Marks MP. Prospective analysis of clinical outcomes after percutaneous vertebroplasty for painful osteoporotic vertebral body fractures. AJNR Am J Neuroradiol. 2005 Aug;26(7):1623-8.
PubMed 16091504Deramond H, Darrason R GP. Percutaneous vertebroplasty with acrylic cement in the treatment of aggressive spinal angiomas. Rachis. 1989;1(2):143-53.
Jensen ME, Evans AJ, Mathis JM, Kallmes DF, Cloft HJ, Dion JE. Percutaneous polymethylmethacrylate vertebroplasty in the treatment of osteoporotic vertebral body compression fractures: technical aspects. AJNR Am J Neuroradiol. 1997 Nov-Dec;18(10):1897-904.
PubMed 9403451Deramond H, Depriester C, Galibert P, Le Gars D. Percutaneous vertebroplasty with polymethylmethacrylate. Technique, indications, and results. Radiol Clin North Am. 1998 May;36(3):533-46. doi: 10.1016/s0033-8389(05)70042-7.
PubMed 9597071Gangi A, Guth S, Imbert JP, Marin H, Dietemann JL. Percutaneous vertebroplasty: indications, technique, and results. Radiographics. 2003 Mar-Apr;23(2):e10. doi: 10.1148/rg.e10.
PubMed 12889460Gu YF, Li YD, Wu CG, Sun ZK, He CJ. Safety and efficacy of percutaneous vertebroplasty and interventional tumor removal for metastatic spinal tumors and malignant vertebral compression fractures. AJR Am J Roentgenol. 2014 Mar;202(3):W298-305. doi: 10.2214/AJR.12.10497.
PubMed 24555629Chen G, Luo ZP, Zhang H, Nalajala B, Yang H. Percutaneous kyphoplasty in the treatment of painful osteoblastic metastatic spinal lesions. J Clin Neurosci. 2013 Jul;20(7):948-50. doi: 10.1016/j.jocn.2012.08.010. Epub 2013 May 3.
PubMed 23647710Pereira LP, Clarencon F, Cormier E, Rose M, Jean B, Le Jean L, Chiras J. Safety and effectiveness of percutaneous sacroplasty: a single-centre experience in 58 consecutive patients with tumours or osteoporotic insufficient fractures treated under fluoroscopic guidance. Eur Radiol. 2013 Oct;23(10):2764-72. doi: 10.1007/s00330-013-2881-3. Epub 2013 May 21.
PubMed 23689309Weill A, Chiras J, Simon JM, Rose M, Sola-Martinez T, Enkaoua E. Spinal metastases: indications for and results of percutaneous injection of acrylic surgical cement. Radiology. 1996 Apr;199(1):241-7. doi: 10.1148/radiology.199.1.8633152.
PubMed 8633152Chiras J, Depriester C, Weill A, Sola-Martinez MT, Deramond H. [Percutaneous vertebral surgery. Technics and indications]. J Neuroradiol. 1997 Jun;24(1):45-59. French.
PubMed 9303944
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vertebroplasty In The Treatment Of Acute Fracture Trial (The VITTA Trial)
- ClinicalTrials.gov ID
- NCT02370628
- Acronym / sponsor ID
- VITTA / CE14.334
- Conditions
- Vertebral Compression Fractures
- Keywords
- percutaneous vertebroplasty, facet block
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: too few participants enrolled and few interested patients in three years
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 17 Apr 2015 (actual)
- Primary completion
- 5 Jun 2018 (actual)
- Study completion
- 5 Jun 2018 (actual)
- First posted
- 25 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The VITTA trial is a randomized, controlled, single-blinded, cross-over trial comparing percutaneous vertebroplasty with facet block in patients with acute (<1month) and painful vertebral compression fractures.
The treatment offered for vertebral compression fractures (VCFs) in the interventional arm of the trial is vertebroplasty, which will be performed in accordance with the standardized protocol of the Canadian Association of Radiologists. Patients in the control arm will receive facet block, where a long-acting local anesthetic agent and corticosteroids are injected in the spinal articular facets at the affected level.
Detailed description
Vertebroplasty is a procedure used to stabilize broken vertebrae, the bones that form the spine. This study will evaluate the effectiveness of vertebroplasty for the treatment of acute vertebral fractures.
The VITTA trial is a randomized, controlled, single-blinded, cross-over trial comparing percutaneous vertebroplasty with facet block in patients with acute (<1 month) and painful vertebral compression fractures.
Vertebral compression fractures (VCFs) frequently result in debilitating pain, impaired functional status and bad quality of life. Percutaneous vertebroplasty (PV) is a treatment for VCFs originally developed in France in the late 1980s and first performed in America in the mid-1990s. The procedure involves percutaneous application of bone cement (polymethylmethacrylate) into collapsed vertebrae.
VCFs are a significant public health problem with approximately 750,000 new fractures occurring in the United States each year, a number that is projected to rise as the population ages. In fact, one quarter of adults over the age of 50 will suffer at least one VCF in their lifetime. VCFs cause short term and occasionally long-term pain and disability, and although not immediately life threatening, they are associated with long term mortality. Before the advent of PV, the treatment for VCFs was limited to medical therapy- addressing the pain associated with the fracture but not the fracture itself thus making VCFs practically the only skeletal fracture not treated with orthopedic surgery. Since the introduction of vertebroplasty, over 800 papers, technical notes, and reviews that address this technique have been published with the overwhelming majority reporting significant pain relief and advocating the adoption of the procedure into common practice. Unfortunately, most of these studies had low evidence level and poor scientific design until randomized clinical trials were published in 2009.
Vertebroplasty for refractory back pain (after a period of conservative management of 1 month) constituted the main indication in the overwhelming majority of studies published so far. Although those studies have largely suggested that it does not offer significant improvement in pain or functional status relative to medical therapy or infusion of local anesthesia after this acute phase, the data remains inconclusive and of poor scientific quality. The present study proposes a different rationale: the benefits of vertebroplasty may be occurring in the acute phase (before 1 month) by providing immediate pain relief to the patient, hence allowing early mobilization and preventing medical complications associated with bed rest. In other terms, vertebroplasty may be a first line, acute phase treatment. If the investigators hypothesis holds true, an adequately powered clinical trial may provide sufficient evidence to change the medical indications for vertebroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous vertebroplasty (PV) | Experimental | Procedure: Percutaneous vertebroplasty, Procedure: Facet blockThe procedure involves percutaneous application of bone cement (polymethylmethacrylate) into collapsed vertebrae. |
| Facet block | Active comparator | Procedure: Facet blockinjection of anti-inflammatory and analgesic drugs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 years
- Presence of:
- at least one and at most two acute VCF (< 6 weeks) at levels caudate to T4, confirmed with physical examination and radiographic imaging
- if timing of the fracture is unclear, the following criteria are required for inclusion in the trial
- Physical examination showing axial back pain likely secondary to the VCF with restricted mobilization (score not maximum on any one of the following Barthel's Index items: transfer, mobility, bathing, dressing, stairs and toilet use)
Key exclusion criteria (3 listed)
- Recent (<30 days) major surgery causing debilitating pain
- Coagulopathy or thrombocytopenia precluding interventional treatment
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous vertebroplastyThe procedure involves percutaneous application of bone cement (polymethylmethacrylate) into collapsed vertebrae, and has been used for treatment of patients with osteoporosis who have severe or prolonged pain following vertebral compression fracture, as well as those with painful, aggressive hemangiomas and osteolytic neoplasms. In our trial, vertebroplasty shall be performed in two steps: * Step 1: facet block * Step 2: cement infusion Therefore, patients in both arms will undergo Step 1 since our control intervention serves as a routine first part of our active intervention. | Procedure or surgery | Percutaneous vertebroplasty (PV) |
| Facet blockA long-acting local anesthetic agent and corticosteroids are injected in the spinal articular facets at the affected level. All patients will undergo facet block since it serves as a routine first part to percutaneous vertebroplasty. | Procedure or surgery | Facet block, Percutaneous vertebroplasty (PV) |
Primary outcome
Achieving a score of 75 or higher on the Barthel Index functional evaluation score
Time frame: 30 days after treatment
3 secondary outcomes
Rate of cross-over to the alternative treatment
Time frame: 15 days after treatment
Level of pain as measured by the visual analogue pain scale
Time frame: at 15 days and 30 days
Proportion of patients located at home
Time frame: 15 days
Results and safety
The study was stopped early (reason given: too few participants enrolled and few interested patients in three years). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
- BackgroundBourgoin P, Weill A, Tampieri D. CAR Standard for Performance of the Percutaneous Vertebroplasty. Can Assoc Radiol. 2002;(March).
- Background: PubMed 19657122Kallmes DF, Comstock BA, Heagerty PJ, Turner JA, Wilson DJ, Diamond TH, Edwards R, Gray LA, Stout L, Owen S, Hollingworth W, Ghdoke B, Annesley-Williams DJ, Ralston SH, Jarvik JG. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. 2009 Aug 6;361(6):569-79. doi: 10.1056/NEJMoa0900563.
- Background: PubMed 19657121Buchbinder R, Osborne RH, Ebeling PR, Wark JD, Mitchell P, Wriedt C, Graves S, Staples MP, Murphy B. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. 2009 Aug 6;361(6):557-68. doi: 10.1056/NEJMoa0900429.
- Background: PubMed 23696683Comstock BA, Sitlani CM, Jarvik JG, Heagerty PJ, Turner JA, Kallmes DF. Investigational vertebroplasty safety and efficacy trial (INVEST): patient-reported outcomes through 1 year. Radiology. 2013 Oct;269(1):224-31. doi: 10.1148/radiol.13120821. Epub 2013 May 21.
- Background: PubMed 17353335Voormolen MH, Mali WP, Lohle PN, Fransen H, Lampmann LE, van der Graaf Y, Juttmann JR, Jansssens X, Verhaar HJ. Percutaneous vertebroplasty compared with optimal pain medication treatment: short-term clinical outcome of patients with subacute or chronic painful osteoporotic vertebral compression fractures. The VERTOS study. AJNR Am J Neuroradiol. 2007 Mar;28(3):555-60.
- Background: PubMed 16091504Do HM, Kim BS, Marcellus ML, Curtis L, Marks MP. Prospective analysis of clinical outcomes after percutaneous vertebroplasty for painful osteoporotic vertebral body fractures. AJNR Am J Neuroradiol. 2005 Aug;26(7):1623-8.
- BackgroundDeramond H, Darrason R GP. Percutaneous vertebroplasty with acrylic cement in the treatment of aggressive spinal angiomas. Rachis. 1989;1(2):143-53.
- Background: PubMed 9403451Jensen ME, Evans AJ, Mathis JM, Kallmes DF, Cloft HJ, Dion JE. Percutaneous polymethylmethacrylate vertebroplasty in the treatment of osteoporotic vertebral body compression fractures: technical aspects. AJNR Am J Neuroradiol. 1997 Nov-Dec;18(10):1897-904.
- Background: PubMed 9597071Deramond H, Depriester C, Galibert P, Le Gars D. Percutaneous vertebroplasty with polymethylmethacrylate. Technique, indications, and results. Radiol Clin North Am. 1998 May;36(3):533-46. doi: 10.1016/s0033-8389(05)70042-7.
- Background: PubMed 12889460Gangi A, Guth S, Imbert JP, Marin H, Dietemann JL. Percutaneous vertebroplasty: indications, technique, and results. Radiographics. 2003 Mar-Apr;23(2):e10. doi: 10.1148/rg.e10.
- Background: PubMed 24555629Gu YF, Li YD, Wu CG, Sun ZK, He CJ. Safety and efficacy of percutaneous vertebroplasty and interventional tumor removal for metastatic spinal tumors and malignant vertebral compression fractures. AJR Am J Roentgenol. 2014 Mar;202(3):W298-305. doi: 10.2214/AJR.12.10497.
- Background: PubMed 23647710Chen G, Luo ZP, Zhang H, Nalajala B, Yang H. Percutaneous kyphoplasty in the treatment of painful osteoblastic metastatic spinal lesions. J Clin Neurosci. 2013 Jul;20(7):948-50. doi: 10.1016/j.jocn.2012.08.010. Epub 2013 May 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Raymond, MD principal investigator
CHUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous vertebroplasty and Facet block in people with Vertebral Compression Fractures, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: too few participants enrolled and few interested patients in three years). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achieving a score of 75 or higher on the Barthel Index functional evaluation score (time frame: 30 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02370628, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2018.