Distal Radius FractureDRFNCT05175118
Minimally Invasive Fixation for Distal Radius Fractures
A study testing Minimal invasive surgical fixation of distal radius Fractures in people with Distal Radius Fracture, run by Assiut University.
Trial summary
Minimally invasive surgery avoids the tissue damage and impairment of physiological function caused by open surgery because of its precise location techniques and can effectively promote the early recovery of wrist function. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Minimal invasive surgical fixation of distal radius Fractures
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2024to Oct 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with unstable distal radial fracture
- skeletally mature Patients.
- Acute fractures within one weeks of injury
Who cannot join
- contaminated open fractures.
- fractures associated with vascular injury requiring repair, and suspected pathologic Fracture
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Minimally Invasive Surgical Fixation for Unstable Fractures of the Distal End Radius in Adults
Minimally invasive surgery avoids the tissue damage and impairment of physiological function caused by open surgery because of its precise location techniques and can effectively promote the early recovery of wrist function. Under conditions of no cutting of fracture fragments, no blood supply compromise in the fracture fragments
Read the detailed description
Distal radial fracture is common fracture and internal fixation needed in many cases so we use minimally invasive fixation in this study to minimize open surgery compilations
- Conditions
- Distal Radius Fracture
- Being tested
- Minimal invasive surgical fixation of distal radius Fractures
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal invasive surgical fixation of distal radius FracturesDevice
Fixation of distal radius Fractures by minimal invasive technique
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive fixation | Other | Minimally Invasive Surgical Fixation for Unstable Fractures of the distal end Radius in Adults Receives: Device: Minimal invasive surgical fixation of distal radius Fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture healing
Rate of fracture healing
Measured: 6 minths
Wrist function
Percentage of restoration of wrist function
Measured: One year
Secondary outcomes (1)
Fracture compilations
Percentage of fracture healing compilations
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start20 Dec 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 Assiut UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdalraouf M Ghozaly, Assiut University
- Investigators
- Ab Ma Ghozaly, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175118
- Sponsor's protocol ID
- Minimally invasive fixation
- Acronym
- DRF
- Status last verified
- Aug 2024
- First submitted
- 1 Dec 2021
- Last updated
- 5 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study analytic results
Publications
Liverneaux PA. The minimally invasive approach for distal radius fractures and malunions. J Hand Surg Eur Vol. 2018 Feb;43(2):121-130. doi: 10.1177/1753193417745259. Epub 2017 Dec 12.
PubMed 29231799Chmielnicki M, Prokop A. [New minimally invasive approach for palmar plating in distal radius fractures]. Z Orthop Unfall. 2015 Feb;153(1):25-8. doi: 10.1055/s-0034-1383103. Epub 2015 Feb 27. German.
PubMed 25723576Igeta Y, Vernet P, Facca S, Naroura I, Hidalgo Diaz JJ, Diaz JJH, Liverneaux PA. The minimally invasive flexor carpi radialis approach: a new perspective for distal radius fractures. Eur J Orthop Surg Traumatol. 2018 Dec;28(8):1515-1522. doi: 10.1007/s00590-018-2124-z. Epub 2018 Jan 24.
PubMed 29368237Slutsky DJ. Outcomes assessment in wrist surgery. J Wrist Surg. 2013 Feb;2(1):1-4. doi: 10.1055/s-0033-1333892. No abstract available.
PubMed 24436782
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Surgical Fixation for Unstable Fractures of the Distal End Radius in Adults
- ClinicalTrials.gov ID
- NCT05175118
- Acronym / sponsor ID
- DRF / Minimally invasive fixation
- Conditions
- Distal Radius Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Dec 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 3 Jan 2022 (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.
Minimally invasive surgery avoids the tissue damage and impairment of physiological function caused by open surgery because of its precise location techniques and can effectively promote the early recovery of wrist function. Under conditions of no cutting of fracture fragments, no blood supply compromise in the fracture fragments
Detailed description
Distal radial fracture is common fracture and internal fixation needed in many cases so we use minimally invasive fixation in this study to minimize open surgery compilations
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive fixation | Other | Device: Minimal invasive surgical fixation of distal radius FracturesMinimally Invasive Surgical Fixation for Unstable Fractures of the distal end Radius in Adults |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with unstable distal radial fracture
- skeletally mature Patients.
- Acute fractures within one weeks of injury
Key exclusion criteria (2 listed)
- contaminated open fractures.
- fractures associated with vascular injury requiring repair, and suspected pathologic Fracture
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 |
|---|---|---|
| Minimal invasive surgical fixation of distal radius FracturesFixation of distal radius Fractures by minimal invasive technique | Device | Minimally invasive fixation |
Primary outcome
Fracture healing
Time frame: 6 minths
Rate of fracture healing
Wrist function
Time frame: One year
Percentage of restoration of wrist function
1 secondary outcome
Fracture compilations
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Background: PubMed 29231799Liverneaux PA. The minimally invasive approach for distal radius fractures and malunions. J Hand Surg Eur Vol. 2018 Feb;43(2):121-130. doi: 10.1177/1753193417745259. Epub 2017 Dec 12.
- Background: PubMed 25723576Chmielnicki M, Prokop A. [New minimally invasive approach for palmar plating in distal radius fractures]. Z Orthop Unfall. 2015 Feb;153(1):25-8. doi: 10.1055/s-0034-1383103. Epub 2015 Feb 27. German.
- Background: PubMed 29368237Igeta Y, Vernet P, Facca S, Naroura I, Hidalgo Diaz JJ, Diaz JJH, Liverneaux PA. The minimally invasive flexor carpi radialis approach: a new perspective for distal radius fractures. Eur J Orthop Surg Traumatol. 2018 Dec;28(8):1515-1522. doi: 10.1007/s00590-018-2124-z. Epub 2018 Jan 24.
- Background: PubMed 24436782Slutsky DJ. Outcomes assessment in wrist surgery. J Wrist Surg. 2013 Feb;2(1):1-4. doi: 10.1055/s-0033-1333892. No abstract available.
- Individual participant dataSharing planned: No. Study analytic results
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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.
Ab Ma Ghozaly principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Minimal invasive surgical fixation of distal radius Fractures in people with Distal Radius Fracture, run by Assiut University.
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 3 inclusion and 2 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 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Ab Ma Ghozaly (01555167657, Abdalraoofmahmoud4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture healing (time frame: 6 minths). 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 NCT05175118, which also lists 4 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 5 Aug 2024.