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Completed

NCT Number: NCT06901973

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

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.

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Key information

Conditions

Distal Radius Fracture Arm Injuries Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

17 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Clinics of Bukavu

Bukavu, South Kivu, 570, Democratic Republic of the Congo

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intrafocal pinning

Procedure

Intrafocal pinning involves the percutaneous insertion of Kirschner wires to stabilize the distal radius fracture, often followed by plaster immobilization.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Official University of Bukavu

Other

Registry information

Official study title

Epidemiological, Radiological, Therapeutic and Evolutionary Aspects of Distal Radius Fractures in Adults in South Kivu: a Multi-center Cross-sectional Study.

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Mar 30, 2025
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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