Dual fixation using a flexible intramedullary nail plus a low-profile 2.7 mm mini locked plate for distal ulna fractures
Official title: Evaluation of Dual Fixation of Distal Ulna Fractures by Flexible Intramedullary Nail and Mini Locked Plate 2.7 mm
Run by Sohag University · NCT07440251 · Data updated 2026-11-12
This trial will test whether combining a flexible nail and a 2.7 mm mini locked plate gives stronger fixation and faster recovery for adults with displaced or unstable distal ulna fractures.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 18 (estimated) |
| Sponsor | Sohag University Academic / other |
| Locations | 1 site (Sohag) |
| Status | Recruiting |
| Started | February 20, 2026 |
| Main results expected | August 2026 |
| Study ends | September 2026 |
| Registry record updated | April 24, 2026 |
| Trial ID | NCT07440251 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥18) with displaced or unstable distal ulna fractures, either isolated or with associated distal radius fractures, who do not have severe soft-tissue injury, pathological fractures, or uncontrolled systemic conditions affecting bone healing are ideal candidates.
✕Probably not a fit
Patients with severe soft-tissue injury (Gustilo type III), pathological fractures, or medical conditions like uncontrolled diabetes or severe osteoporosis are unlikely to benefit from this dual fixation approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center surgical intervention that combines an intramedullary flexible nail with a low-profile 2.7 mm mini locked plate to provide orthogonal (hybrid) stabilization of displaced or unstable distal ulna fractures. The approach aims to share mechanical load between devices to improve biomechanical stability, reduce hardware failure, and permit earlier wrist mobilization. Adults aged 18 and older with isolated distal ulna fractures or those with associated distal radius fractures are eligible, while patients with severe open wounds (Gustilo type III), pathological fractures, or systemic conditions that impair bone healing are excluded. Clinical and radiological outcomes will be followed after surgery to document union, complication rates, and functional recovery at the treating center.
Why it matters
Potential benefit: If successful, the combined fixation could lower the risk of nonunion and hardware failure while allowing earlier motion and a quicker return to function.
How similar studies have gone: Biomechanical data and small clinical series support hybrid or orthogonal fixation for complex distal ulna and forearm fractures, but large randomized trials are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Faculty of medicine sohag university
Sohag, Egypt Recruiting
Study contacts
- Study coordinator: Mostafa Ali Hamed
- Email: mostafaalihamed97@gmail.com
- Phone: +201006850240
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.