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NCT Number: NCT07440251

Evaluation of Dual Fixation of Distal Ulna Fractures by Flexible Intramedullary Nail and Mini Locked Plate 2.7 mm.

Although isolated fixation methods, such as intramedullary nails or plate fixation, are commonly employed, certain fracture patterns-particularly comminuted, osteoporotic, or unstable fractures- represent a challenge to achieve stable fixation and restoring normal anatomy .

Dual fixation, combining an intramedullary nail with a low-profile 2.7-mm mini locked plate, aims to capitalize on the strengths of both techniques-a concept known as "orthogonal or hybrid stabilization". This combined approach provides enhanced biomechanical stability, allows for early mobilization by sharing the mechanical load, and minimizes the risk of non-union or hardware failure. Studying the clinical and radiological outcomes of this dual fixation strategy is essential to establish its efficacy and safety in managing complex distal ulna fractures.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine sohag university

Sohag, Egypt

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Displaced distal ulna fractures either isolated or with associated distal radius fractures.
  • Unstable distal ulna fractures
  • Age group: [Adults aged 18 years and older].

Exclusion criteria

  • Open fractures with severe soft tissue injury (Gustilo type III).
  • Pathological fractures.
  • Patients with systemic conditions affecting bone healing e.g. uncontrolled diabetes and severe osteoporosis.

Treatment and study plan

Dual fixation of distal ulna fractures by flexible intramedullary nail and mini locked plate 2.7 mm

Procedure

Evaluation of dual fixation of distal ulna fractures by flexible intramedullary nail and mini locked plate 2.7 mm.

Primary outcomes

  1. Radiological union

    Time frame: 24 Weeks

    Number of patients achieving complete bone healing as assessed by serial X-rays (presence of bridging callus on 3 out of 4 cortices).

    Unit of Measure: Number of Participants.

Secondary outcomes

  1. Mean Hand Grip Strength

    Time frame: 24 weeks

    Measurement of the physical force of the hand using a calibrated Jamar hydraulic hand dynamometer. The average of three successive trials with the affected hand will be recorded.

    Unit of Measure: Kilograms.

  2. Range of Motion (ROM) of the affected joint (wrist)

    Time frame: 24 weeks

    Clinical measurement of the degree of movement in the joint (flexion, extension, pronation, and supination) using a standard goniometer.

    Unit of Measure: Degrees.

Study contacts

Contact information is provided by the study sponsor or research team.

Mostafa Ali Hamed

CONTACT

[email protected]

+201006850240

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Evaluation of Dual Fixation of Distal Ulna Fractures by Flexible Intramedullary Nail and Mini Locked Plate 2.7 mm

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Apr 24, 2026

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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