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

NCT07440251 | Recruiting

• 1 other identifier: Soh-Med-26-2-1MS
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Distal Ulna Fracture

Keywords

Distal ulna fractures; Dual fixation

Outcome Measures

Primary Outcomes (1)

• Radiological union

  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.

  24 Weeks

Secondary Outcomes (2)

• Mean Hand Grip Strength

  24 weeks

• Range of Motion (ROM) of the affected joint (wrist)

  24 weeks

Study Arms (1)

Distal ulna fractures

OTHER

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

Interventions

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.

Distal ulna fractures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Faculty of medicine sohag university

Sohag, Egypt

RECRUITING

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Central Study Contacts

Mostafa Ali Hamed

CONTACT

+201006850240; mostafaalihamed97@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident , Orthopaedics and Traumatology Department

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 27, 2026
• Study Start: February 20, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-02

Locations

EG (1)