Distal Radius Fractures in Adults: A Multi-Center Study in South Kivu

March 23, 2025 updated by: Official University of Bukavu

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

192

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
45 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Official University of Bukavu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

March 23, 2025

First Submitted That Met QC Criteria

March 23, 2025

First Posted (Actual)

March 30, 2025

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 23, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UBukavu

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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