Distal Radius FractureNCT06901973
Distal Radius Fractures in Adults: A Multi-Center Study in South Kivu
An observational study of Distal Radius Fracture, run by Official University of Bukavu at 1 site in Democratic Republic of the Congo.
Trial summary
The goal of this observational study is to describe the epidemiological, radiological, therapeutic, and evolutionary characteristics of distal radius fractures in adults in the Bukavu Health District, South Kivu, DRC. . Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Intrafocal pinning
- Type of treatment
- Surgery or procedure
- How many people
- 192 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 1 Jan 2018to 31 Dec 2023
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of adults diagnosed with distal radius fractures (DRFs) who were admitted, treated, and followed up across 16 hospitals and university medical centers in the Bukavu Health District, South Kivu, Eastern Democratic Republic of Congo (DRC), between January 1, 2018, and December 31, 2023.
Who may be able to join
- Patients aged 17 years or older at the time of injury.
- Diagnosed with a distal radius fracture via clinical and radiological assessment.
- Admitted, treated, and followed up at one of the 16 participating institutions.
- Complete medical records available, including epidemiological, clinical, radiological, therapeutic, and outcome data.
Who cannot join
- Patients under 17 years of age.
- Incomplete or missing medical records.
- Fractures not involving the distal radius.
- Patients transferred to non-participating facilities without follow-up data.
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
University Clinics of Bukavu
Bukavu, South Kivu, 570
About this study
Official title: Epidemiological, Radiological, Therapeutic and Evolutionary Aspects of Distal Radius Fractures in Adults in South Kivu: a Multi-center Cross-sectional Study.
The goal of this observational study is to describe the epidemiological, radiological, therapeutic, and evolutionary characteristics of distal radius fractures in adults in the Bukavu Health District, South Kivu, DRC.
. The main question it aims to answer is:
- What are the epidemiological, radiological, therapeutic, and evolutionary characteristics of distal radius fractures in adults in South Kivu, and how does intrafocal nailing influence outcomes such as consolidation time and complication rates in this population?
Participants who have already operated for distal radius fracture will be enrolled in this study.
- Conditions
- Distal Radius Fracture
- Being tested
- Intrafocal pinning
- Keywords
- 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.
Intrafocal pinningProcedure or surgery
Intrafocal pinning involves the percutaneous insertion of Kirschner wires to stabilize the distal radius fracture, often followed by plaster immobilization.
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to consolidation
Definition: The duration (in days) from the initiation of treatment with intrafocal pinning to radiological evidence of fracture healing (union), defined as the presence of bridging callus across the fracture site on X-ray.
Measurement: Calculated retrospectively from medical records, reported as mean ± standard deviation (e.g., 47.56 ± 6.75 days in the study).
Rationale: Consolidation time is a direct indicator of treatment success, reflecting the intervention's ability to stabilize the fracture and promote healing. It is critical in a resource-limited setting where prolonged recovery impacts patient function and healthcare burden.
Data Source: Radiology reports and follow-up records.
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start1 Jan 2018
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distal Radius 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
- Retrospective
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Official University of Bukavu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901973
- Sponsor's protocol ID
- UBukavu
- Status last verified
- Mar 2025
- First submitted
- 23 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
1. Rundgren J, et al. BMC Musculoskelet Disord. 2020;21(1):88. 2. Chinta SR, et al. J Hand Surg Am. 2024;49(2):123-30. 3. Dworkin M, et al. J Am Acad Orthop Surg Glob Res Rev. 2024;8(4):e23.00282.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological, Radiological, Therapeutic and Evolutionary Aspects of Distal Radius Fractures in Adults in South Kivu: a Multi-center Cross-sectional Study.
- ClinicalTrials.gov ID
- NCT06901973
- Acronym / sponsor ID
- UBukavu
- Conditions
- Distal Radius Fracture
- Keywords
- DISTAL RADIUS FRACTURES
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Official University of BukavuUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 30 Mar 2025 (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.
The goal of this observational study is to describe the epidemiological, radiological, therapeutic, and evolutionary characteristics of distal radius fractures in adults in the Bukavu Health District, South Kivu, DRC.
. The main question it aims to answer is:
- What are the epidemiological, radiological, therapeutic, and evolutionary characteristics of distal radius fractures in adults in South Kivu, and how does intrafocal nailing influence outcomes such as consolidation time and complication rates in this population?
Participants who have already operated for distal radius fracture will be enrolled in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of adults diagnosed with distal radius fractures (DRFs) who were admitted, treated, and followed up across 16 hospitals and university medical centers in the Bukavu Health District, South Kivu, Eastern Democratic Republic of Congo (DRC), between January 1, 2018, and December 31, 2023.
Key inclusion criteria (4 listed)
- Patients aged 17 years or older at the time of injury.
- Diagnosed with a distal radius fracture via clinical and radiological assessment.
- Admitted, treated, and followed up at one of the 16 participating institutions.
- Complete medical records available, including epidemiological, clinical, radiological, therapeutic, and outcome data.
Key exclusion criteria (4 listed)
- Patients under 17 years of age.
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 |
|---|---|---|
| Intrafocal pinningIntrafocal pinning involves the percutaneous insertion of Kirschner wires to stabilize the distal radius fracture, often followed by plaster immobilization. | Procedure or surgery | – |
Primary outcome
Time to consolidation
Time frame: 45 days
Definition: The duration (in days) from the initiation of treatment with intrafocal pinning to radiological evidence of fracture healing (union), defined as the presence of bridging callus across the fracture site on X-ray. Measurement: Calculated retrospectively from medical records, reported as mean ± standard deviation (e.g., 47.56 ± 6.75 days in the study). Rationale: Consolidation time is a direct indicator of treatment success, reflecting the intervention's ability to stabilize the fracture and promote healing. It is critical in a resource-limited setting where prolonged recovery impacts patient function and healthcare burden. Data Source: Radiology reports and follow-up records.
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 30 Mar 2025.
- Results publication1. Rundgren J, et al. BMC Musculoskelet Disord. 2020;21(1):88. 2. Chinta SR, et al. J Hand Surg Am. 2024;49(2):123-30. 3. Dworkin M, et al. J Am Acad Orthop Surg Glob Res Rev. 2024;8(4):e23.00282.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Official University of Bukavu at 1 site in Democratic Republic of the Congo.
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 4 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 30 Mar 2025. 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 Democratic Republic of the Congo. 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?
Time to consolidation (time frame: 45 days). 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 NCT06901973, which also lists 1 linked publication.
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 30 Mar 2025.