Distal Radius FractureNCT04554472
Usefulness of Intraoperative Ultrasound in a Volar Plate Distal Radius Fixation
An observational study of Distal Radius Fracture and Ultrasound, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Distal radius fracture is a common injury with a high percentage of surgical treatment. In the last decades, volar plate fixation has been the treatment of choice. However, complication rates range between 6% and 50% according to the different study groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fracture, Ultrasound
- What is being tested?
- Intraoperative ultrasound
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 22 Sep 2020to 10 Oct 2022
- How long will I take part?
- 3 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a distal radius fracture with a surgical indication
Who may be able to join
- Patients over 18 years of age
- Both sexes
- Surgical criteria distal radius fracture.
- Patients with sufficient understanding capacity to read and understand an informed consent.
Who cannot join
- Patients with a history of any type of surgical intervention on the same limb distal to the elbow.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Ultrasound Valid in Distal Radius Fixation With a Volar Plate?
Distal radius fracture is a common injury with a high percentage of surgical treatment. In the last decades, volar plate fixation has been the treatment of choice. However, complication rates range between 6% and 50% according to the different study groups. One of the main complications is due to errors in screw measurement given the particular anatomy of the distal radius.
Numerous views in addition to the standard ones have been described in order to increase the specificity and sensitivity in the detection of poorly implanted screws. In the absence of a radiological projection superior to another, we believe that the use of intraoperative ultrasound can provide a non-invasive and quick revision element that avoids scope time for both: the patient and the surgical team.
Read the detailed description
Patients will be recruited in a sequential mode after signing the usual informed consent (IC) as well as the consent to accept participation in the study.
The intervention will be carried out as usual and, once the radiological checks have been carried out, an ultrasound of the wrist extensor compartments will be performed. Compartments will be studied individually in order to detect invasion of the dorsal cortex by the screws.
All surgeries will be performed only by members of the upper limb trauma team or hand surgery unit.
Postoperative follow-up will be the standard one prior to the present study.
- Conditions
- Distal Radius Fracture, Ultrasound
- Being tested
- Intraoperative ultrasound
- Keywords
- Distal radius volar fixation, Intraoperative ultrasound, screw protrusion detection
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative ultrasoundDiagnostic test
During the surgery, the standard AP and lateral x-rays will be performed. Additional projections (lateral 30 degrees tilt, and dorsal tangential view) will also be registered. Finally an intraoperative ultrasound of the wrist extensor tendons will be taken, checking the compartments individually in order to detect invasion of the dorsal cortex by the screws. In case of no protrusion, the patient will be registered as a correct fixation. Otherwise, it will be specified which position of the plate and which compartment the screw/s protrude. A screw with a correct measurement will then be replaced and implanted and recorded as a measurement error.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients with a distal radius fracture requiring surgery who meet the exclusion and inclusion criteria Receives: Diagnostic Test: Intraoperative ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screw protrusion
Perform an ultrasound of each dorsal compartment of the operated wrist
Measured: Intraoperative
Secondary outcomes (1)
Surgical time
Measure the additional surgical time involved in ultrasound view
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start22 Sep 2020
- Primary completion1 Oct 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alvaro Toro-Aguilera, MD, PhD, Principal investigator, Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554472
- Sponsor's protocol ID
- IIBSP-ECO-2019-86
- Status last verified
- Oct 2022
- First submitted
- 14 Sep 2020
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be extracted and published collectively with respect to: 1. Demographic data: number of participants, sex distribution, age distribution, fracture complexity distribution, time of surgery 2. Screw detection rate of each x-ray projection 3. Screw detection rate of intraoperative ultrasound
Publications
Chung KC, Spilson SV. The frequency and epidemiology of hand and forearm fractures in the United States. J Hand Surg Am. 2001 Sep;26(5):908-15. doi: 10.1053/jhsu.2001.26322.
PubMed 11561245Nellans KW, Kowalski E, Chung KC. The epidemiology of distal radius fractures. Hand Clin. 2012 May;28(2):113-25. doi: 10.1016/j.hcl.2012.02.001. Epub 2012 Apr 14.
PubMed 22554654Jupiter JB, Fernandez DL. Complications following distal radial fractures. Instr Course Lect. 2002;51:203-19. No abstract available.
PubMed 12064104Stoops TK, Santoni BG, Clark NM, Bauer AA, Shoji C, Schwartz-Fernandes F. Sensitivity and Specificity of Skyline and Carpal Shoot-Through Fluoroscopic Views of Volar Plate Fixation of the Distal Radius: A Cadaveric Investigation of Dorsal Cortex Screw Penetration. Hand (N Y). 2017 Nov;12(6):551-556. doi: 10.1177/1558944716677336. Epub 2016 Nov 1.
PubMed 29091485Joseph SJ, Harvey JN. The dorsal horizon view: detecting screw protrusion at the distal radius. J Hand Surg Am. 2011 Oct;36(10):1691-3. doi: 10.1016/j.jhsa.2011.07.020. Epub 2011 Aug 23.
PubMed 21864994Balfour GW. Using Ultrasound to Prevent Screw Penetration. J Hand Surg Am. 2016 Mar;41(3):453-6. doi: 10.1016/j.jhsa.2015.12.020. Epub 2016 Jan 21.
PubMed 26803568Bergsma M, Denk K, Doornberg JN, van den Bekerom MPJ, Kerkhoffs GMMJ, Jaarsma RL, Obdeijn MC. Volar Plating: Imaging Modalities for the Detection of Screw Penetration. J Wrist Surg. 2019 Dec;8(6):520-530. doi: 10.1055/s-0039-1681026. Epub 2019 Mar 5.
PubMed 31815069Thorninger R, Madsen ML, Waever D, Borris LC, Rolfing JHD. Complications of volar locking plating of distal radius fractures in 576 patients with 3.2 years follow-up. Injury. 2017 Jun;48(6):1104-1109. doi: 10.1016/j.injury.2017.03.008. Epub 2017 Mar 10.
PubMed 28336098
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Ultrasound Valid in Distal Radius Fixation With a Volar Plate?
- ClinicalTrials.gov ID
- NCT04554472
- Acronym / sponsor ID
- IIBSP-ECO-2019-86
- Conditions
- Distal Radius Fracture, Ultrasound
- Keywords
- Distal radius volar fixation, Intraoperative ultrasound, screw protrusion detection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 18 Sep 2020 (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.
Distal radius fracture is a common injury with a high percentage of surgical treatment. In the last decades, volar plate fixation has been the treatment of choice. However, complication rates range between 6% and 50% according to the different study groups. One of the main complications is due to errors in screw measurement given the particular anatomy of the distal radius.
Numerous views in addition to the standard ones have been described in order to increase the specificity and sensitivity in the detection of poorly implanted screws. In the absence of a radiological projection superior to another, we believe that the use of intraoperative ultrasound can provide a non-invasive and quick revision element that avoids scope time for both: the patient and the surgical team.
Detailed description
Patients will be recruited in a sequential mode after signing the usual informed consent (IC) as well as the consent to accept participation in the study.
The intervention will be carried out as usual and, once the radiological checks have been carried out, an ultrasound of the wrist extensor compartments will be performed. Compartments will be studied individually in order to detect invasion of the dorsal cortex by the screws.
All surgeries will be performed only by members of the upper limb trauma team or hand surgery unit.
Postoperative follow-up will be the standard one prior to the present study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: Intraoperative ultrasoundPatients with a distal radius fracture requiring surgery who meet the exclusion and inclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a distal radius fracture with a surgical indication
Key inclusion criteria (4 listed)
- Patients over 18 years of age
- Both sexes
- Surgical criteria distal radius fracture.
- Patients with sufficient understanding capacity to read and understand an informed consent.
Key exclusion criteria (1 listed)
- Patients with a history of any type of surgical intervention on the same limb distal to the elbow.
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 |
|---|---|---|
| Intraoperative ultrasoundDuring the surgery, the standard AP and lateral x-rays will be performed. Additional projections (lateral 30 degrees tilt, and dorsal tangential view) will also be registered. Finally an intraoperative ultrasound of the wrist extensor tendons will be taken, checking the compartments individually in order to detect invasion of the dorsal cortex by the screws. In case of no protrusion, the patient will be registered as a correct fixation. Otherwise, it will be specified which position of the plate and which compartment the screw/s protrude. A screw with a correct measurement will then be replaced and implanted and recorded as a measurement error. | Diagnostic test | Study group |
Primary outcome
Screw protrusion
Time frame: Intraoperative
Perform an ultrasound of each dorsal compartment of the operated wrist
1 secondary outcome
Surgical time
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Results publication: PubMed 11561245Chung KC, Spilson SV. The frequency and epidemiology of hand and forearm fractures in the United States. J Hand Surg Am. 2001 Sep;26(5):908-15. doi: 10.1053/jhsu.2001.26322.
- Results publication: PubMed 22554654Nellans KW, Kowalski E, Chung KC. The epidemiology of distal radius fractures. Hand Clin. 2012 May;28(2):113-25. doi: 10.1016/j.hcl.2012.02.001. Epub 2012 Apr 14.
- Results publication: PubMed 12064104Jupiter JB, Fernandez DL. Complications following distal radial fractures. Instr Course Lect. 2002;51:203-19. No abstract available.
- Results publication: PubMed 29091485Stoops TK, Santoni BG, Clark NM, Bauer AA, Shoji C, Schwartz-Fernandes F. Sensitivity and Specificity of Skyline and Carpal Shoot-Through Fluoroscopic Views of Volar Plate Fixation of the Distal Radius: A Cadaveric Investigation of Dorsal Cortex Screw Penetration. Hand (N Y). 2017 Nov;12(6):551-556. doi: 10.1177/1558944716677336. Epub 2016 Nov 1.
- Results publication: PubMed 21864994Joseph SJ, Harvey JN. The dorsal horizon view: detecting screw protrusion at the distal radius. J Hand Surg Am. 2011 Oct;36(10):1691-3. doi: 10.1016/j.jhsa.2011.07.020. Epub 2011 Aug 23.
- Results publication: PubMed 26803568Balfour GW. Using Ultrasound to Prevent Screw Penetration. J Hand Surg Am. 2016 Mar;41(3):453-6. doi: 10.1016/j.jhsa.2015.12.020. Epub 2016 Jan 21.
- Results publication: PubMed 31815069Bergsma M, Denk K, Doornberg JN, van den Bekerom MPJ, Kerkhoffs GMMJ, Jaarsma RL, Obdeijn MC. Volar Plating: Imaging Modalities for the Detection of Screw Penetration. J Wrist Surg. 2019 Dec;8(6):520-530. doi: 10.1055/s-0039-1681026. Epub 2019 Mar 5.
- Results publication: PubMed 28336098Thorninger R, Madsen ML, Waever D, Borris LC, Rolfing JHD. Complications of volar locking plating of distal radius fractures in 576 patients with 3.2 years follow-up. Injury. 2017 Jun;48(6):1104-1109. doi: 10.1016/j.injury.2017.03.008. Epub 2017 Mar 10.
- Individual participant dataSharing planned: No. Data will be extracted and published collectively with respect to: 1. Demographic data: number of participants, sex distribution, age distribution, fracture complexity distribution, time of surgery 2. Screw detection rate of each x-ray projection 3. Screw detection rate of intraoperative ultrasound
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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.
Alvaro Toro-Aguilera, MD, PhD principal investigator
Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau
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 Distal Radius Fracture and Ultrasound, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 1 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: finished, as of the sponsor's last update on 12 Oct 2022. 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 Spain. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Screw protrusion (time frame: Intraoperative). 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 NCT04554472, which also lists 8 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 12 Oct 2022.