Vertebral FractureNCT05815251
Porous Titanium Microspheres in Kyphoplasty
An observational study of Vertebral Fracture and Kyphoplasty, run by Unit of neurosurgery, Departement of Neurosciences, University of Torino at 1 site in Italy.
Trial summary
Study is a prospective observational, performed in the context of normal clinical practice, of patients with osteoporotic vertebral compression fractures identified as candidates for kyphoplasty treatment with porous trabecular titanium microspheres (see whether to put commercial name and company). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Vertebral Fracture, Kyphoplasty
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2021to 31 Dec 2024
- Phase
- Observational
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with documented presence of vertebral compression fracture/osteoporotic collapse. Osteoporosis is the most frequent bone disease with high incidence in the population over 55 years of age. The occurrence of vertebral compression fractures is very common in patients with osteoporosis either in association with minor trauma or as a spontaneous event.
Who may be able to join
- Presence of osteoporotic vertebral fracture occurred within the previous 6 weeks and documented by CT, MRI, or X-ray in relation to the diagnostic pathway the patient underwent
- Patients with fractures according to AO Spine-DGOU OF2, OF3 and OF4 classification are enrollable limited to cases in which soma height loss is less than 60% and in the absence of vertical split type pincer fracture.
- Diagnosis of osteoporosis preceding or concurrent with fracture occurrence, regardless of current therapy
- Favorable for inclusion in the study with signed informed consent, available for follow-up up to 1 year.
- Availability of adequate preoperative radiologic documentation: CT or MRI of the lumbar spine; RX required for evaluation of kyphosis.
- Availability of adequate and comprehensive clinical information including presence of ODI score, MRQ, VAS.
Who cannot join
- Presence of oncologic, metabolic, or endocrinologic diseases related to bone fragility
- Age < 55 years
- Previous treatment of arthrodesis, vertebroplasty, or percutaneous kyphoplasty for previous fractures
- Presence of neurological deficits in the lower limbs medullary or radicular prior to fracture occurrence
- Unavailability for follow-up for at least 1 year
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Università degli studi di Torino
Turin, 10126
Fabio Cofano, M.D., +39 3331341404, fabio.cofano@gmail.com
Diego Garbossa, Professor, +39 3498739698, diego.garbossa@unito.it
About this study
Official title: Kiphoplasty With Porous Titanium Microspheres for Treatment of Vertebral Osteoporotic Compression Fractures: Perspective Study on Efficacy and Safety
Study is a prospective observational, performed in the context of normal clinical practice, of patients with osteoporotic vertebral compression fractures identified as candidates for kyphoplasty treatment with porous trabecular titanium microspheres (see whether to put commercial name and company). The study does not involve any interference with the patient's diagnostic-therapeutic course The objective of the study is the clinical-radiological evaluation of the efficacy of kyphoplasty treatment with trabecular porous titanium spheres in terms of pain control and reduction of kyphotic deformity following fracture. Further evaluation of the safety of the treatment in terms of absence of intraoperative adverse events and material-related toxicity.
Read the detailed description
The study is purely observational, sponsored, and does not involve any change in the diagnostic, therapeutic, and follow-up course of patients selected on a clinical basis for kyphoplasty with porous titanium microspheres. involved but only an analysis and comparison of data during normal clinical-surgical activity. The study aims to evaluate, in a prospective-observational setting, the benefit of this treatment on pain control and prevention of deformity following fracture. Kyphoplasty with porous titanium spheres has already been used successfully and without obvious safety issues.
No additional radiologic exposures are planned over and above those in the normal courses of care and follow-up. No additional diagnostic investigations are planned. The study ensures data collection with full respect for privacy. There are no conflicts of interest for any of the board members.
The effectiveness of the therapy used is tested by considering the ODI, MRQ, VAS score expressed in numerical value before ("pre" condition) and after ("post" condition) kyphoplasty treatment as the observed quantity. The sample size is evaluated based on the primary objective of demonstrating a significant reduction in disability and pain after treatment in the range of 20%. With a significance of 0.05, a power of the test of 0.95, assuming to compare the two samples by t test for paired data the sample size can be in the order of 15 patients.
The evaluation of secondary end-points, which is not binding, will be carried out on similar sample numerosity.
All patients with the following requirements may be included in the observational study. The patient will be asked to give informed consent for inclusion in the study. Contextually, consent will be acquired for the processing of personal data in relation to the current privacy law. Consents must be acquired from the Investigating Surgeon performing the procedure in full respect of the Physician-Patient relationship. The informed consent will include acceptance of the follow-up period of at least 1 year with the possibility of telephone follow-up as well. The patient will also be given an information sheet regarding the purpose and type of the study and the expression of consent to participate. Attached is the informed consent form, patient information sheet and consent for personal data processing and privacy.
The procedure is performed under local anesthesia with the aid of possible sedation. Patient in prone position on radiolucent table with possibility of fluoroscopy in antero-posterior and latero-lateral projection. Biportal (bilateral) access with dedicated trokar to be placed in the anterior part of the fractured vertebral soma with convergent trajectory and transpeduncular access. Replacement of trokar with with larger cannula. Placement and dilatation of kyphoplasty balloon (15 ml volume) bilaterally. Introduction with dedicated instrument of porous titanium microspheres with possibility of using compactor to increase consistency of overall cast of material. Procedure performed with fluoroscopic control.
Data collection.
All data entered in the CRF data collection form must be collected for recruited patients:
- generality: age, sex, smoking habit, previous diagnosis of osteoporosis or new diagnosis of osteoporosis
- level and classification of fracture (AOSpine)
- operative data: date of surgery, type of access, number of spheres used, type of kyphoplasty pole, intraoperative adverse events, and technical difficulties
- clinical data: diagnosis, date of fracture, ODI, MRIQ, VAS back, days of postoperative hospital stay. For clinical and outcome assessment, point scales ODI score (Oswestry Disability Index) Roland-Morris Questionnaire, Back Pain Visual Analogue Scale (VAS) whose reliability is well reported in the literature (bibliographic entries) are used.
- Radiological data: segmental kyphosis, kyphosis of the fractured soma, possible progression of the fracture. Segmental kyphosis is calculated as Cobb angle, and changes (delta) pre-postoperative and at follow-up are reported.
Protection of privacy.
Data collection remains within the center promoting the research in the context of normal clinical activity and in compliance with current regulations. As reported, further consent to the processing of personal data is acquired. Radiological images will be obtained during the procedure and hospitalization will be archived regularly. Images performed externally in other hospitals or diagnostic centers will be acquired and stored, with the express consent of the patient, by the referring Investigating Surgeon. All images will eventually be used for scientific activities in a completely anonymous form.
All recruited patients should be followed, unless the patient explicitly withdraws consent, in follow-up for at least 1 year. the entire duration of the study initially planned to be 5 years. Follow-up evaluations will have to involve the acquisition of all data already indicated in section 4.4 to be entered in the data collection form (CRF-FU). The follow-up clinical evaluation will involve the acquisition of ODI, RMQ questionnaires in addition to VAS back at 1, 3 and 12 months.
Follow-up is the responsibility of the referring Investigating Surgeon in full respect of the Physician-Patient relationship and Privacy. A telephone evaluation may be performed on patients who are unavailable for outpatient evaluations or cannot be reached by administering ODI, RMQ and VAS back and interview.
Follow-up will also include the performance and acquisition of a lumbar spine X-ray performed in standing load at 1 month, 3 months and at 12 months as in the normal clinical course of patients undergoing percutaneous kyphoplasty procedures. Thus, patients are not subjected to additional examinations for participation in the study. Follow-up CT and MRI examinations will be performed eventually, as usual, only for supervening clinical reasons such as persistence of pain or appearance of new neurological deficits.
Participants in the study as investigators are all Surgeons with proven experience in spine surgery selected from within the medical team of the proposing center. Upon association of a Surgeon, a letter of intent in duplicate is required to be signed to emphasize the required commitment and the roles of the investigator.
Participating Investigating Surgeons may recruit patients in the context of their regular surgical practice. Recruitment should be prospective and the patient should be enrolled prior to kyphoplasty treatment in order to avoid selection bias related to the clinical outcome obtained.
- Conditions
- Vertebral Fracture, Kyphoplasty
- Keywords
- osteoporotic fracture, vertebral augmentation, vertebral compression fracture
- Medical subject headings
- Spinal Fractures, Osteoporotic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sphereplast group | Patients with osteoporotic vertebral compression fractures identified as candidates for kyphoplasty treatment with porous trabecular titanium microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability index
Evaluation of the effectiveness of treatment on reducing disability secondary to the occurrence of osteoporotic compression fracture. The used scale is: Oswestry Disability Index (ODI) The effectiveness of the therapy used was tested by considering the ODI expressed (from 0 to 50) in numerical value before ("pre" condition) and after ("post" condition) kyphoplasty treatment as the observed quantity.
Measured: 1 year
Patients with Pain improvement
Evaluation of the effectiveness of treatment on reducing pain after the treatment. The used scale is Back Pain Visual Analogue Scale (VAS) from 0 (no pain) to 10 (maximum pain).
The effectiveness of the therapy used was tested by considering VAS scale expressed in numerical value before ("pre" condition) and after ("post" condition) kyphoplasty treatment as the observed quantity.
Measured: 1 year
Secondary outcomes (3)
Percentage of patients with side effects
Evaluation of treatment safety in terms of absence of side effects including neurological deficits, embolic phenomena, adverse reactions to the material
, occurrence of surgical site infections, expressed in percentage (%) and in a binomial variable (less or more than 20%)
Measured: 1 year
Rate of Kyphosis recovery
valuation of reduction by kyphoplasty treatment of kyphosis resulting from the fracture and deformation of the fractured vertebral body (segmental Cobb angle, degrees of kyphosis of the fractured soma)
Measured: 3 months
Rate of patients with dislocation of the sphere
It t means the presence of a dislocation of the introduced material (the microspheres) outside the fractured vertebra, commonly understood as leakage.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Jan 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Vertebral FractureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unit of neurosurgery, Departement of Neurosciences, University of Torino
- Sponsor type
- University, hospital or other
- Collaborators
- University of Roma La Sapienza
- Responsible party
- Principal investigator, Fabio Cofano, MD, Unit of neurosurgery, Departement of Neurosciences, University of Torino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815251
- Sponsor's protocol ID
- Microsphere001
- Status last verified
- Apr 2023
- First submitted
- 24 Feb 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ravindra VM, Senglaub SS, Rattani A, Dewan MC, Hartl R, Bisson E, Park KB, Shrime MG. Degenerative Lumbar Spine Disease: Estimating Global Incidence and Worldwide Volume. Global Spine J. 2018 Dec;8(8):784-794. doi: 10.1177/2192568218770769. Epub 2018 Apr 24.
PubMed 30560029Martin BI, Mirza SK, Spina N, Spiker WR, Lawrence B, Brodke DS. Trends in Lumbar Fusion Procedure Rates and Associated Hospital Costs for Degenerative Spinal Diseases in the United States, 2004 to 2015. Spine (Phila Pa 1976). 2019 Mar 1;44(5):369-376. doi: 10.1097/BRS.0000000000002822.
PubMed 30074971Makino T, Kaito T, Fujiwara H, Honda H, Sakai Y, Takenaka S, Yoshikawa H, Yonenobu K. Risk Factors for Poor Patient-Reported Quality of Life Outcomes After Posterior Lumbar Interbody Fusion: An Analysis of 2-Year Follow-up. Spine (Phila Pa 1976). 2017 Oct 1;42(19):1502-1510. doi: 10.1097/BRS.0000000000002137.
PubMed 28248893Kaiser MG, Eck JC, Groff MW, Watters WC 3rd, Dailey AT, Resnick DK, Choudhri TF, Sharan A, Wang JC, Mummaneni PV, Dhall SS, Ghogawala Z. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 1: introduction and methodology. J Neurosurg Spine. 2014 Jul;21(1):2-6. doi: 10.3171/2014.4.SPINE14257.
PubMed 24980578Costa F, Anania CD, Zileli M, Servadei F, Fornari M. Lumbar Spinal Stenosis: Introduction to the World Federation of Neurosurgical Societies (WFNS) Spine Committee Recommendations. World Neurosurg X. 2020 Mar 10;7:100075. doi: 10.1016/j.wnsx.2020.100075. eCollection 2020 Jul.
PubMed 32613188Eck JC, Sharan A, Ghogawala Z, Resnick DK, Watters WC 3rd, Mummaneni PV, Dailey AT, Choudhri TF, Groff MW, Wang JC, Dhall SS, Kaiser MG. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 7: lumbar fusion for intractable low-back pain without stenosis or spondylolisthesis. J Neurosurg Spine. 2014 Jul;21(1):42-7. doi: 10.3171/2014.4.SPINE14270.
PubMed 24980584Wang JC, Dailey AT, Mummaneni PV, Ghogawala Z, Resnick DK, Watters WC 3rd, Groff MW, Choudhri TF, Eck JC, Sharan A, Dhall SS, Kaiser MG. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 8: lumbar fusion for disc herniation and radiculopathy. J Neurosurg Spine. 2014 Jul;21(1):48-53. doi: 10.3171/2014.4.SPINE14271.
PubMed 24980585Resnick DK, Watters WC 3rd, Sharan A, Mummaneni PV, Dailey AT, Wang JC, Choudhri TF, Eck J, Ghogawala Z, Groff MW, Dhall SS, Kaiser MG. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 9: lumbar fusion for stenosis with spondylolisthesis. J Neurosurg Spine. 2014 Jul;21(1):54-61. doi: 10.3171/2014.4.SPINE14274.
PubMed 24980586Resnick DK, Watters WC 3rd, Mummaneni PV, Dailey AT, Choudhri TF, Eck JC, Sharan A, Groff MW, Wang JC, Ghogawala Z, Dhall SS, Kaiser MG. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 10: lumbar fusion for stenosis without spondylolisthesis. J Neurosurg Spine. 2014 Jul;21(1):62-6. doi: 10.3171/2014.4.SPINE14275.
PubMed 24980587Groff MW, Dailey AT, Ghogawala Z, Resnick DK, Watters WC 3rd, Mummaneni PV, Choudhri TF, Eck JC, Sharan A, Wang JC, Dhall SS, Kaiser MG. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 12: pedicle screw fixation as an adjunct to posterolateral fusion. J Neurosurg Spine. 2014 Jul;21(1):75-8. doi: 10.3171/2014.4.SPINE14277.
PubMed 24980589
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kiphoplasty With Porous Titanium Microspheres for Treatment of Vertebral Osteoporotic Compression Fractures: Perspective Study on Efficacy and Safety
- ClinicalTrials.gov ID
- NCT05815251
- Acronym / sponsor ID
- Microsphere001
- Conditions
- Vertebral Fracture, Kyphoplasty
- Keywords
- osteoporotic fracture, vertebral augmentation, vertebral compression fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Unit of neurosurgery, Departement of Neurosciences, University of TorinoUniversity, hospital or other
- Collaborators
- University of Roma La Sapienza
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Apr 2023 (actual)
- 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.
Study is a prospective observational, performed in the context of normal clinical practice, of patients with osteoporotic vertebral compression fractures identified as candidates for kyphoplasty treatment with porous trabecular titanium microspheres (see whether to put commercial name and company). The study does not involve any interference with the patient's diagnostic-therapeutic course The objective of the study is the clinical-radiological evaluation of the efficacy of kyphoplasty treatment with trabecular porous titanium spheres in terms of pain control and reduction of kyphotic deformity following fracture. Further evaluation of the safety of the treatment in terms of absence of intraoperative adverse events and material-related toxicity.
Detailed description
The study is purely observational, sponsored, and does not involve any change in the diagnostic, therapeutic, and follow-up course of patients selected on a clinical basis for kyphoplasty with porous titanium microspheres. involved but only an analysis and comparison of data during normal clinical-surgical activity. The study aims to evaluate, in a prospective-observational setting, the benefit of this treatment on pain control and prevention of deformity following fracture. Kyphoplasty with porous titanium spheres has already been used successfully and without obvious safety issues.
No additional radiologic exposures are planned over and above those in the normal courses of care and follow-up. No additional diagnostic investigations are planned. The study ensures data collection with full respect for privacy. There are no conflicts of interest for any of the board members.
The effectiveness of the therapy used is tested by considering the ODI, MRQ, VAS score expressed in numerical value before ("pre" condition) and after ("post" condition) kyphoplasty treatment as the observed quantity. The sample size is evaluated based on the primary objective of demonstrating a significant reduction in disability and pain after treatment in the range of 20%. With a significance of 0.05, a power of the test of 0.95, assuming to compare the two samples by t test for paired data the sample size can be in the order of 15 patients.
The evaluation of secondary end-points, which is not binding, will be carried out on similar sample numerosity.
All patients with the following requirements may be included in the observational study. The patient will be asked to give informed consent for inclusion in the study. Contextually, consent will be acquired for the processing of personal data in relation to the current privacy law. Consents must be acquired from the Investigating Surgeon performing the procedure in full respect of the Physician-Patient relationship. The informed consent will include acceptance of the follow-up period of at least 1 year with the possibility of telephone follow-up as well. The patient will also be given an information sheet regarding the purpose and type of the study and the expression of consent to participate. Attached is the informed consent form, patient information sheet and consent for personal data processing and privacy.
The procedure is performed under local anesthesia with the aid of possible sedation. Patient in prone position on radiolucent table with possibility of fluoroscopy in antero-posterior and latero-lateral projection. Biportal (bilateral) access with dedicated trokar to be placed in the anterior part of the fractured vertebral soma with convergent trajectory and transpeduncular access. Replacement of trokar with with larger cannula. Placement and dilatation of kyphoplasty balloon (15 ml volume) bilaterally. Introduction with dedicated instrument of porous titanium microspheres with possibility of using compactor to increase consistency of overall cast of material. Procedure performed with fluoroscopic control.
Data collection.
All data entered in the CRF data collection form must be collected for recruited patients:
- generality: age, sex, smoking habit, previous diagnosis of osteoporosis or new diagnosis of osteoporosis
- level and classification of fracture (AOSpine)
- operative data: date of surgery, type of access, number of spheres used, type of kyphoplasty pole, intraoperative adverse events, and technical difficulties
- clinical data: diagnosis, date of fracture, ODI, MRIQ, VAS back, days of postoperative hospital stay. For clinical and outcome assessment, point scales ODI score (Oswestry Disability Index) Roland-Morris Questionnaire, Back Pain Visual Analogue Scale (VAS) whose reliability is well reported in the literature (bibliographic entries) are used.
- Radiological data: segmental kyphosis, kyphosis of the fractured soma, possible progression of the fracture. Segmental kyphosis is calculated as Cobb angle, and changes (delta) pre-postoperative and at follow-up are reported.
Protection of privacy.
Data collection remains within the center promoting the research in the context of normal clinical activity and in compliance with current regulations. As reported, further consent to the processing of personal data is acquired. Radiological images will be obtained during the procedure and hospitalization will be archived regularly. Images performed externally in other hospitals or diagnostic centers will be acquired and stored, with the express consent of the patient, by the referring Investigating Surgeon. All images will eventually be used for scientific activities in a completely anonymous form.
All recruited patients should be followed, unless the patient explicitly withdraws consent, in follow-up for at least 1 year. the entire duration of the study initially planned to be 5 years. Follow-up evaluations will have to involve the acquisition of all data already indicated in section 4.4 to be entered in the data collection form (CRF-FU). The follow-up clinical evaluation will involve the acquisition of ODI, RMQ questionnaires in addition to VAS back at 1, 3 and 12 months.
Follow-up is the responsibility of the referring Investigating Surgeon in full respect of the Physician-Patient relationship and Privacy. A telephone evaluation may be performed on patients who are unavailable for outpatient evaluations or cannot be reached by administering ODI, RMQ and VAS back and interview.
Follow-up will also include the performance and acquisition of a lumbar spine X-ray performed in standing load at 1 month, 3 months and at 12 months as in the normal clinical course of patients undergoing percutaneous kyphoplasty procedures. Thus, patients are not subjected to additional examinations for participation in the study. Follow-up CT and MRI examinations will be performed eventually, as usual, only for supervening clinical reasons such as persistence of pain or appearance of new neurological deficits.
Participants in the study as investigators are all Surgeons with proven experience in spine surgery selected from within the medical team of the proposing center. Upon association of a Surgeon, a letter of intent in duplicate is required to be signed to emphasize the required commitment and the roles of the investigator.
Participating Investigating Surgeons may recruit patients in the context of their regular surgical practice. Recruitment should be prospective and the patient should be enrolled prior to kyphoplasty treatment in order to avoid selection bias related to the clinical outcome obtained.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sphereplast group | – | –Patients with osteoporotic vertebral compression fractures identified as candidates for kyphoplasty treatment with porous trabecular titanium microspheres |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with documented presence of vertebral compression fracture/osteoporotic collapse. Osteoporosis is the most frequent bone disease with high incidence in the population over 55 years of age. The occurrence of vertebral compression fractures is very common in patients with osteoporosis either in association with minor trauma or as a spontaneous event.
Key inclusion criteria (6 listed)
- Presence of osteoporotic vertebral fracture occurred within the previous 6 weeks and documented by CT, MRI, or X-ray in relation to the diagnostic pathway the patient underwent
- Patients with fractures according to AO Spine-DGOU OF2, OF3 and OF4 classification are enrollable limited to cases in which soma height loss is less than 60% and in the absence of vertical split type pincer fracture.
- Diagnosis of osteoporosis preceding or concurrent with fracture occurrence, regardless of current therapy
- Favorable for inclusion in the study with signed informed consent, available for follow-up up to 1 year.
- Availability of adequate preoperative radiologic documentation: CT or MRI of the lumbar spine; RX required for evaluation of kyphosis.
Key exclusion criteria (5 listed)
- Presence of oncologic, metabolic, or endocrinologic diseases related to bone fragility
- Age < 55 years
- Previous treatment of arthrodesis, vertebroplasty, or percutaneous kyphoplasty for previous fractures
- Presence of neurological deficits in the lower limbs medullary or radicular prior to fracture occurrence
- Unavailability for follow-up for at least 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disability index
Time frame: 1 year
Evaluation of the effectiveness of treatment on reducing disability secondary to the occurrence of osteoporotic compression fracture. The used scale is: Oswestry Disability Index (ODI) The effectiveness of the therapy used was tested by considering the ODI expressed (from 0 to 50) in numerical value before ("pre" condition) and after ("post" condition) kyphoplasty treatment as the observed quantity.
Patients with Pain improvement
Time frame: 1 year
Evaluation of the effectiveness of treatment on reducing pain after the treatment. The used scale is Back Pain Visual Analogue Scale (VAS) from 0 (no pain) to 10 (maximum pain). The effectiveness of the therapy used was tested by considering VAS scale expressed in numerical value before ("pre" condition) and after ("post" condition) kyphoplasty treatment as the observed quantity.
3 secondary outcomes
Percentage of patients with side effects
Time frame: 1 year
Rate of Kyphosis recovery
Time frame: 3 months
Rate of patients with dislocation of the sphere
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Background: PubMed 30560029Ravindra VM, Senglaub SS, Rattani A, Dewan MC, Hartl R, Bisson E, Park KB, Shrime MG. Degenerative Lumbar Spine Disease: Estimating Global Incidence and Worldwide Volume. Global Spine J. 2018 Dec;8(8):784-794. doi: 10.1177/2192568218770769. Epub 2018 Apr 24.
- Background: PubMed 30074971Martin BI, Mirza SK, Spina N, Spiker WR, Lawrence B, Brodke DS. Trends in Lumbar Fusion Procedure Rates and Associated Hospital Costs for Degenerative Spinal Diseases in the United States, 2004 to 2015. Spine (Phila Pa 1976). 2019 Mar 1;44(5):369-376. doi: 10.1097/BRS.0000000000002822.
- Background: PubMed 28248893Makino T, Kaito T, Fujiwara H, Honda H, Sakai Y, Takenaka S, Yoshikawa H, Yonenobu K. Risk Factors for Poor Patient-Reported Quality of Life Outcomes After Posterior Lumbar Interbody Fusion: An Analysis of 2-Year Follow-up. Spine (Phila Pa 1976). 2017 Oct 1;42(19):1502-1510. doi: 10.1097/BRS.0000000000002137.
- Background: PubMed 24980578Kaiser MG, Eck JC, Groff MW, Watters WC 3rd, Dailey AT, Resnick DK, Choudhri TF, Sharan A, Wang JC, Mummaneni PV, Dhall SS, Ghogawala Z. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 1: introduction and methodology. J Neurosurg Spine. 2014 Jul;21(1):2-6. doi: 10.3171/2014.4.SPINE14257.
- Background: PubMed 32613188Costa F, Anania CD, Zileli M, Servadei F, Fornari M. Lumbar Spinal Stenosis: Introduction to the World Federation of Neurosurgical Societies (WFNS) Spine Committee Recommendations. World Neurosurg X. 2020 Mar 10;7:100075. doi: 10.1016/j.wnsx.2020.100075. eCollection 2020 Jul.
- Background: PubMed 24980584Eck JC, Sharan A, Ghogawala Z, Resnick DK, Watters WC 3rd, Mummaneni PV, Dailey AT, Choudhri TF, Groff MW, Wang JC, Dhall SS, Kaiser MG. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 7: lumbar fusion for intractable low-back pain without stenosis or spondylolisthesis. J Neurosurg Spine. 2014 Jul;21(1):42-7. doi: 10.3171/2014.4.SPINE14270.
- Background: PubMed 24980585Wang JC, Dailey AT, Mummaneni PV, Ghogawala Z, Resnick DK, Watters WC 3rd, Groff MW, Choudhri TF, Eck JC, Sharan A, Dhall SS, Kaiser MG. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 8: lumbar fusion for disc herniation and radiculopathy. J Neurosurg Spine. 2014 Jul;21(1):48-53. doi: 10.3171/2014.4.SPINE14271.
- Background: PubMed 24980586Resnick DK, Watters WC 3rd, Sharan A, Mummaneni PV, Dailey AT, Wang JC, Choudhri TF, Eck J, Ghogawala Z, Groff MW, Dhall SS, Kaiser MG. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 9: lumbar fusion for stenosis with spondylolisthesis. J Neurosurg Spine. 2014 Jul;21(1):54-61. doi: 10.3171/2014.4.SPINE14274.
- Background: PubMed 24980587Resnick DK, Watters WC 3rd, Mummaneni PV, Dailey AT, Choudhri TF, Eck JC, Sharan A, Groff MW, Wang JC, Ghogawala Z, Dhall SS, Kaiser MG. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 10: lumbar fusion for stenosis without spondylolisthesis. J Neurosurg Spine. 2014 Jul;21(1):62-6. doi: 10.3171/2014.4.SPINE14275.
- Background: PubMed 24980589Groff MW, Dailey AT, Ghogawala Z, Resnick DK, Watters WC 3rd, Mummaneni PV, Choudhri TF, Eck JC, Sharan A, Wang JC, Dhall SS, Kaiser MG. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 12: pedicle screw fixation as an adjunct to posterolateral fusion. J Neurosurg Spine. 2014 Jul;21(1):75-8. doi: 10.3171/2014.4.SPINE14277.
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Vertebral Compression Fractures, Pathological Fracture
Active, not recruitingPhase 2
Cement Augmentation in Preventing Vertebral Body Compression Fracture Following Spine Stereotactic Radiosurgery in Patients With Solid Tumors and Spinal Metastases
Metastatic Malignant Neoplasm in the Spine, Metastatic Malignant Solid Neoplasm
Not yet recruitingObservational study
Controlled Reduction of AO Spine B3 Fractures in Ankylosing Spinal Disorders Using an Inflatable Positioning Device: Technical Note and Retrospective Single-centre Case Series
Spine Fracture, Osteoporosis
Active, not recruiting
Sickle Cell Disease (SCD) Bone Pain Study
Sickle Cell Disease, Sickle Cell Anemia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertebral Fracture and Kyphoplasty, run by Unit of neurosurgery, Departement of Neurosciences, University of Torino at 1 site in Italy.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 Apr 2023. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fulvio Tartara, M.D. (+39 3356847079, tartarafulvio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability index (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT05815251, which also lists 10 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 21 Apr 2023.