Stress Fracture FootFootPCCTNCT06024798
Detecting and Assessing Leg and Foot Stress Fractures Using Photon Counting CT
An observational study of Stress Fracture Foot and Stress Fracture Ankle, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
Stress fractures (fatigue or insufficiency fracture) are caused by the mismatch between bone strength and chronic stress applied to the bone. The vast majority of these fractures occur in the lower extremity. Early-stage diagnosis is crucial to optimize patient care. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Stress Fracture Foot, Stress Fracture Ankle, Stress Fracture of Tibia
- What is being tested?
- Photon-Counting-Computed-Tomography
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2023to 30 Jan 2025
- How long will I take part?
- 13 Weeks
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: In cooperation with the Foot Clinic at the Balgrist University Hospital Zurich, potential study candidates with suspected stress fracture who will undergo an MRI to confirm the diagnosis are prospectively screened and proposed to join the study.
Who may be able to join
- ≥ 16 years of age. Minor study subjects can have an additional signature by the parent or legal guardian
- Clinically suspected stress or insufficiency fracture of the lower extremity
- Written consent of study participation
- Patients who will have an MRI to confirm the diagnosis of a suspected stress fracture
Who cannot join
- < 16 years of age
- Pregnancy
- Metal implants
- Postoperative situation
- Infection or tumorous disease affecting the lower extremity
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Balgrist University Hospital
Zurich, Canton of Zurich, 8008
Stephan Wirth, PD Dr.med., +41 44 386 11 11, Stephan.Wirth@balgrist.ch
About this study
Official title: Assessing Patients With Suspected Stress or Insufficiency Fracture of the Lower Extremity With Photon-Counting-Computed-Tomography
Stress fractures (fatigue or insufficiency fracture) are caused by the mismatch between bone strength and chronic stress applied to the bone. The vast majority of these fractures occur in the lower extremity. Early-stage diagnosis is crucial to optimize patient care. Appropriate imaging is relevant in confirming diagnosis after clinical suspicion of stress fractures. Radiographs have low sensitivity, so a relevant number of fractures go undetected. MRI has a high sensitivity, but its availability is limited, and its respective examination time is prolonged. This study investigates the diagnostic accuracy of PCCT in lower extremity stress fractures as a dose-saving technology, guaranteeing an examination according to the ALARA-principle (as low as reasonably achievable).
Read the detailed description
Stress fracture is caused by the mismatch between bone strength and chronical stress applied to the bone, which is insufficient to cause an acute fracture, but a stress fracture does not heal itself. One can subclassify it into fatigue fracture (overuse of a healthy bone) and insufficiency fracture (normal use of a weakened bone). Fatigue fractures usually happen in healthy athletes or military recruits, whereas insufficiency fracture appear in patients with underlying metabolic or nutritional disorder (e.g. osteoporosis). On radiographs and Computed Tomography (CT), stress fractures are defined as round or linear intracortical lucency or an intertrabecular sclerotic line, which rarely intersects the cortex. Radiograph is a cost-effective and highly available modality in detecting fractures, showing however a moderate sensitivity in detecting stress fractures: 15-35% on the initial and 30-70% on the follow-up imaging. CT, another modality highly available in most hospital settings, shows a similar moderate sensitivity of 32-38% with however a corresponding high specificity of 88-98% on initial imaging. Similar specificity values can be observed for magnetic resonance imaging (MRI) and nuclear scintigraphy. Although their availability is limited and their respective examination time is prolonged, they outperform the x-ray based technologies in term of sensitivity (68-98% MRI and 50-97% nuclear scintigraphy, respectively).
The introduction of dual-energy technology advanced CT from a pure anatomical evaluation tool to a combined anatomical and functional modality. Every material has a specific absorption number, which can be assessed by applying two different energies (high and low x-ray tube voltages). This method of multispectral imaging has been established and clinically implemented in detecting gout and characterizing renal stones. Further studies have shown that DECT can depict bone marrow edema, a marker of early stress fracture and a common finding in MRI. However, this has yet not been implemented in clinical practice.
The photon-counting-computed-tomography (PCCT) has been introduced recently, enabling an energy dependent separation of photons over the whole x-ray energy spectrum. This results in reduced background noise, improved image resolution and multispectral imaging without the necessity of an additional acquisition at a different energy level. An initial study has shown already shown the superiority of PCCT by better detecting and characterizing small renal stones, when compared to conventional dual-energy computed tomography (DECT).
In this project the investigators aim to include clinically referred patients with suspected stress fracture of the lower extremity who will have an MRI to confirm the diagnosis of a suspected stress fracture. The subjects will be scanned on the new PCCT system with dose saving technology, guaranteeing an examination according to the ALARA-principle (as low as reasonably achievable). The investigators will not inject iodine contrast media and they will expect a median dose of 2-4 mSv (millisieverts). Since this will not exceed the threshold of 5 mSv, this project will be classified as category A.
- Conditions
- Stress Fracture Foot, Stress Fracture Ankle, Stress Fracture of Tibia, Stress Fracture Metatarsal, Lower Limb Fracture
- Being tested
- Photon-Counting-Computed-Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photon-Counting-Computed-TomographyDiagnostic test
Initial and follow up (after 4 weeks) PCCT acquisition of the affected area of the lower extremity. Image acquisition will be performed on the PCCT
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of a fracture
Presence/absence of a fracture
Measured: Day 1, 4weeks follow up assessment
Secondary outcomes (2)
Presence of bone edema
Presence/absence of bone edema
Measured: Day 1, 4weeks follow up assessment
Presence of soft tissue edema
Presence/absence of soft tissue edema
Measured: Day1, 4weeks follow up assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start1 Sep 2023
- Primary completion31 Dec 2023
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Stress Fracture FootStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 13 Weeks
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan Wirth, PD Dr.med., Principal investigator, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024798
- Sponsor's protocol ID
- W1024
- Acronym
- FootPCCT
- Status last verified
- Mar 2024
- First submitted
- 21 Aug 2023
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Palmer W, Bancroft L, Bonar F, Choi JA, Cotten A, Griffith JF, Robinson P, Pfirrmann CWA. Glossary of terms for musculoskeletal radiology. Skeletal Radiol. 2020 Jul;49(Suppl 1):1-33. doi: 10.1007/s00256-020-03465-1. Epub 2020 Jun 2.
PubMed 32488336Lassus J, Tulikoura I, Konttinen YT, Salo J, Santavirta S. Bone stress injuries of the lower extremity: a review. Acta Orthop Scand. 2002 Jun;73(3):359-68. doi: 10.1080/000164702320155392.
PubMed 12143987Wright AA, Hegedus EJ, Lenchik L, Kuhn KJ, Santiago L, Smoliga JM. Diagnostic Accuracy of Various Imaging Modalities for Suspected Lower Extremity Stress Fractures: A Systematic Review With Evidence-Based Recommendations for Clinical Practice. Am J Sports Med. 2016 Jan;44(1):255-63. doi: 10.1177/0363546515574066. Epub 2015 Mar 24.
PubMed 25805712Wortman JR, Uyeda JW, Fulwadhva UP, Sodickson AD. Dual-Energy CT for Abdominal and Pelvic Trauma. Radiographics. 2018 Mar-Apr;38(2):586-602. doi: 10.1148/rg.2018170058.
PubMed 29528816Cabarrus MC, Ambekar A, Lu Y, Link TM. MRI and CT of insufficiency fractures of the pelvis and the proximal femur. AJR Am J Roentgenol. 2008 Oct;191(4):995-1001. doi: 10.2214/AJR.07.3714.
PubMed 18806133Gosangi B, Mandell JC, Weaver MJ, Uyeda JW, Smith SE, Sodickson AD, Khurana B. Bone Marrow Edema at Dual-Energy CT: A Game Changer in the Emergency Department. Radiographics. 2020 May-Jun;40(3):859-874. doi: 10.1148/rg.2020190173.
PubMed 32364883Grunz JP, Sailer L, Lang P, Schule S, Kunz AS, Beer M, Hackenbroch C. Dual-energy CT in sacral fragility fractures: defining a cut-off Hounsfield unit value for the presence of traumatic bone marrow edema in patients with osteoporosis. BMC Musculoskelet Disord. 2022 Jul 29;23(1):724. doi: 10.1186/s12891-022-05690-2.
PubMed 35906573Henes FO, Nuchtern JV, Groth M, Habermann CR, Regier M, Rueger JM, Adam G, Grossterlinden LG. Comparison of diagnostic accuracy of Magnetic Resonance Imaging and Multidetector Computed Tomography in the detection of pelvic fractures. Eur J Radiol. 2012 Sep;81(9):2337-42. doi: 10.1016/j.ejrad.2011.07.012. Epub 2011 Sep 15.
PubMed 21924851Bongartz T, Glazebrook KN, Kavros SJ, Murthy NS, Merry SP, Franz WB 3rd, Michet CJ, Veetil BM, Davis JM 3rd, Mason TG 2nd, Warrington KJ, Ytterberg SR, Matteson EL, Crowson CS, Leng S, McCollough CH. Dual-energy CT for the diagnosis of gout: an accuracy and diagnostic yield study. Ann Rheum Dis. 2015 Jun;74(6):1072-7. doi: 10.1136/annrheumdis-2013-205095. Epub 2014 Mar 25.
PubMed 24671771Hidas G, Eliahou R, Duvdevani M, Coulon P, Lemaitre L, Gofrit ON, Pode D, Sosna J. Determination of renal stone composition with dual-energy CT: in vivo analysis and comparison with x-ray diffraction. Radiology. 2010 Nov;257(2):394-401. doi: 10.1148/radiol.10100249. Epub 2010 Aug 31.
PubMed 20807846Esquivel A, Ferrero A, Mileto A, Baffour F, Horst K, Rajiah PS, Inoue A, Leng S, McCollough C, Fletcher JG. Photon-Counting Detector CT: Key Points Radiologists Should Know. Korean J Radiol. 2022 Sep;23(9):854-865. doi: 10.3348/kjr.2022.0377.
PubMed 36047540Marcus RP, Fletcher JG, Ferrero A, Leng S, Halaweish AF, Gutjahr R, Vrtiska TJ, Wells ML, Enders FT, McCollough CH. Detection and Characterization of Renal Stones by Using Photon-Counting-based CT. Radiology. 2018 Nov;289(2):436-442. doi: 10.1148/radiol.2018180126. Epub 2018 Aug 7.
PubMed 30084728Tenforde AS, Fredericson M. Influence of sports participation on bone health in the young athlete: a review of the literature. PM R. 2011 Sep;3(9):861-7. doi: 10.1016/j.pmrj.2011.05.019.
PubMed 21944303Grunz JP, Heidenreich JF, Lennartz S, Weighardt JP, Bley TA, Ergun S, Petritsch B, Huflage H. Spectral Shaping Via Tin Prefiltration in Ultra-High-Resolution Photon-Counting and Energy-Integrating Detector CT of the Temporal Bone. Invest Radiol. 2022 Dec 1;57(12):819-825. doi: 10.1097/RLI.0000000000000901. Epub 2022 Jun 24.
PubMed 35776435Grunz JP, Petritsch B, Luetkens KS, Kunz AS, Lennartz S, Ergun S, Bley TA, Huflage H. Ultra-Low-Dose Photon-Counting CT Imaging of the Paranasal Sinus With Tin Prefiltration: How Low Can We Go? Invest Radiol. 2022 Nov 1;57(11):728-733. doi: 10.1097/RLI.0000000000000887. Epub 2022 May 6.
PubMed 35703452
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Patients With Suspected Stress or Insufficiency Fracture of the Lower Extremity With Photon-Counting-Computed-Tomography
- ClinicalTrials.gov ID
- NCT06024798
- Acronym / sponsor ID
- FootPCCT / W1024
- Conditions
- Stress Fracture Foot, Stress Fracture Ankle, Stress Fracture of Tibia, Stress Fracture Metatarsal, Lower Limb Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 6 Sep 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.
Stress fractures (fatigue or insufficiency fracture) are caused by the mismatch between bone strength and chronic stress applied to the bone. The vast majority of these fractures occur in the lower extremity. Early-stage diagnosis is crucial to optimize patient care. Appropriate imaging is relevant in confirming diagnosis after clinical suspicion of stress fractures. Radiographs have low sensitivity, so a relevant number of fractures go undetected. MRI has a high sensitivity, but its availability is limited, and its respective examination time is prolonged. This study investigates the diagnostic accuracy of PCCT in lower extremity stress fractures as a dose-saving technology, guaranteeing an examination according to the ALARA-principle (as low as reasonably achievable).
Detailed description
Stress fracture is caused by the mismatch between bone strength and chronical stress applied to the bone, which is insufficient to cause an acute fracture, but a stress fracture does not heal itself. One can subclassify it into fatigue fracture (overuse of a healthy bone) and insufficiency fracture (normal use of a weakened bone). Fatigue fractures usually happen in healthy athletes or military recruits, whereas insufficiency fracture appear in patients with underlying metabolic or nutritional disorder (e.g. osteoporosis). On radiographs and Computed Tomography (CT), stress fractures are defined as round or linear intracortical lucency or an intertrabecular sclerotic line, which rarely intersects the cortex. Radiograph is a cost-effective and highly available modality in detecting fractures, showing however a moderate sensitivity in detecting stress fractures: 15-35% on the initial and 30-70% on the follow-up imaging. CT, another modality highly available in most hospital settings, shows a similar moderate sensitivity of 32-38% with however a corresponding high specificity of 88-98% on initial imaging. Similar specificity values can be observed for magnetic resonance imaging (MRI) and nuclear scintigraphy. Although their availability is limited and their respective examination time is prolonged, they outperform the x-ray based technologies in term of sensitivity (68-98% MRI and 50-97% nuclear scintigraphy, respectively).
The introduction of dual-energy technology advanced CT from a pure anatomical evaluation tool to a combined anatomical and functional modality. Every material has a specific absorption number, which can be assessed by applying two different energies (high and low x-ray tube voltages). This method of multispectral imaging has been established and clinically implemented in detecting gout and characterizing renal stones. Further studies have shown that DECT can depict bone marrow edema, a marker of early stress fracture and a common finding in MRI. However, this has yet not been implemented in clinical practice.
The photon-counting-computed-tomography (PCCT) has been introduced recently, enabling an energy dependent separation of photons over the whole x-ray energy spectrum. This results in reduced background noise, improved image resolution and multispectral imaging without the necessity of an additional acquisition at a different energy level. An initial study has shown already shown the superiority of PCCT by better detecting and characterizing small renal stones, when compared to conventional dual-energy computed tomography (DECT).
In this project the investigators aim to include clinically referred patients with suspected stress fracture of the lower extremity who will have an MRI to confirm the diagnosis of a suspected stress fracture. The subjects will be scanned on the new PCCT system with dose saving technology, guaranteeing an examination according to the ALARA-principle (as low as reasonably achievable). The investigators will not inject iodine contrast media and they will expect a median dose of 2-4 mSv (millisieverts). Since this will not exceed the threshold of 5 mSv, this project will be classified as category A.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 13 Weeks
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In cooperation with the Foot Clinic at the Balgrist University Hospital Zurich, potential study candidates with suspected stress fracture who will undergo an MRI to confirm the diagnosis are prospectively screened and proposed to join the study.
Key inclusion criteria (4 listed)
- ≥ 16 years of age. Minor study subjects can have an additional signature by the parent or legal guardian
- Clinically suspected stress or insufficiency fracture of the lower extremity
- Written consent of study participation
- Patients who will have an MRI to confirm the diagnosis of a suspected stress fracture
Key exclusion criteria (5 listed)
- < 16 years of age
- Pregnancy
- Metal implants
- Postoperative situation
- Infection or tumorous disease affecting the lower extremity
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 |
|---|---|---|
| Photon-Counting-Computed-TomographyInitial and follow up (after 4 weeks) PCCT acquisition of the affected area of the lower extremity. Image acquisition will be performed on the PCCT | Diagnostic test | – |
Primary outcome
Presence of a fracture
Time frame: Day 1, 4weeks follow up assessment
Presence/absence of a fracture
2 secondary outcomes
Presence of bone edema
Time frame: Day 1, 4weeks follow up assessment
Presence of soft tissue edema
Time frame: Day1, 4weeks follow up assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Background: PubMed 32488336Palmer W, Bancroft L, Bonar F, Choi JA, Cotten A, Griffith JF, Robinson P, Pfirrmann CWA. Glossary of terms for musculoskeletal radiology. Skeletal Radiol. 2020 Jul;49(Suppl 1):1-33. doi: 10.1007/s00256-020-03465-1. Epub 2020 Jun 2.
- Background: PubMed 12143987Lassus J, Tulikoura I, Konttinen YT, Salo J, Santavirta S. Bone stress injuries of the lower extremity: a review. Acta Orthop Scand. 2002 Jun;73(3):359-68. doi: 10.1080/000164702320155392.
- Background: PubMed 25805712Wright AA, Hegedus EJ, Lenchik L, Kuhn KJ, Santiago L, Smoliga JM. Diagnostic Accuracy of Various Imaging Modalities for Suspected Lower Extremity Stress Fractures: A Systematic Review With Evidence-Based Recommendations for Clinical Practice. Am J Sports Med. 2016 Jan;44(1):255-63. doi: 10.1177/0363546515574066. Epub 2015 Mar 24.
- Background: PubMed 29528816Wortman JR, Uyeda JW, Fulwadhva UP, Sodickson AD. Dual-Energy CT for Abdominal and Pelvic Trauma. Radiographics. 2018 Mar-Apr;38(2):586-602. doi: 10.1148/rg.2018170058.
- Background: PubMed 18806133Cabarrus MC, Ambekar A, Lu Y, Link TM. MRI and CT of insufficiency fractures of the pelvis and the proximal femur. AJR Am J Roentgenol. 2008 Oct;191(4):995-1001. doi: 10.2214/AJR.07.3714.
- Background: PubMed 32364883Gosangi B, Mandell JC, Weaver MJ, Uyeda JW, Smith SE, Sodickson AD, Khurana B. Bone Marrow Edema at Dual-Energy CT: A Game Changer in the Emergency Department. Radiographics. 2020 May-Jun;40(3):859-874. doi: 10.1148/rg.2020190173.
- Background: PubMed 35906573Grunz JP, Sailer L, Lang P, Schule S, Kunz AS, Beer M, Hackenbroch C. Dual-energy CT in sacral fragility fractures: defining a cut-off Hounsfield unit value for the presence of traumatic bone marrow edema in patients with osteoporosis. BMC Musculoskelet Disord. 2022 Jul 29;23(1):724. doi: 10.1186/s12891-022-05690-2.
- Background: PubMed 21924851Henes FO, Nuchtern JV, Groth M, Habermann CR, Regier M, Rueger JM, Adam G, Grossterlinden LG. Comparison of diagnostic accuracy of Magnetic Resonance Imaging and Multidetector Computed Tomography in the detection of pelvic fractures. Eur J Radiol. 2012 Sep;81(9):2337-42. doi: 10.1016/j.ejrad.2011.07.012. Epub 2011 Sep 15.
- Background: PubMed 24671771Bongartz T, Glazebrook KN, Kavros SJ, Murthy NS, Merry SP, Franz WB 3rd, Michet CJ, Veetil BM, Davis JM 3rd, Mason TG 2nd, Warrington KJ, Ytterberg SR, Matteson EL, Crowson CS, Leng S, McCollough CH. Dual-energy CT for the diagnosis of gout: an accuracy and diagnostic yield study. Ann Rheum Dis. 2015 Jun;74(6):1072-7. doi: 10.1136/annrheumdis-2013-205095. Epub 2014 Mar 25.
- Background: PubMed 20807846Hidas G, Eliahou R, Duvdevani M, Coulon P, Lemaitre L, Gofrit ON, Pode D, Sosna J. Determination of renal stone composition with dual-energy CT: in vivo analysis and comparison with x-ray diffraction. Radiology. 2010 Nov;257(2):394-401. doi: 10.1148/radiol.10100249. Epub 2010 Aug 31.
- Background: PubMed 36047540Esquivel A, Ferrero A, Mileto A, Baffour F, Horst K, Rajiah PS, Inoue A, Leng S, McCollough C, Fletcher JG. Photon-Counting Detector CT: Key Points Radiologists Should Know. Korean J Radiol. 2022 Sep;23(9):854-865. doi: 10.3348/kjr.2022.0377.
- Background: PubMed 30084728Marcus RP, Fletcher JG, Ferrero A, Leng S, Halaweish AF, Gutjahr R, Vrtiska TJ, Wells ML, Enders FT, McCollough CH. Detection and Characterization of Renal Stones by Using Photon-Counting-based CT. Radiology. 2018 Nov;289(2):436-442. doi: 10.1148/radiol.2018180126. Epub 2018 Aug 7.
- Report on the use of patient shielding in radiological procedures Swiss Society of Radiobiology and Medical Physics.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Stephan Wirth, PD Dr.med. principal investigator
Balgrist University Hospital
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 Stress Fracture Foot and Stress Fracture Ankle, run by Balgrist University Hospital at 1 site in Switzerland.
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 4 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 28 Mar 2024. 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 Switzerland. 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 Viehöfer Arnd, PD Dr.med. (+41 44 386 57 55, Arnd.Viehöfer@balgrist.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of a fracture (time frame: Day 1, 4weeks follow up assessment). 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 NCT06024798, which also lists 15 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 28 Mar 2024.