Dual fixation using a flexible intramedullary nail plus a low-profile 2.7 mm mini locked plate for distal ulna fractures
Evaluation of Dual Fixation of Distal Ulna Fractures by Flexible Intramedullary Nail and Mini Locked Plate 2.7 mm
NA · Sohag University · NCT07440251
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sohag University (other) |
| Locations | 1 site (Sohag) |
| Trial ID | NCT07440251 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Biomechanical data and small clinical series support hybrid or orthogonal fixation for complex distal ulna and forearm fractures, but large randomized trials are limited.
Eligibility criteria
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 this trial is running
Sohag
- Faculty of medicine sohag university — Sohag, Egypt (RECRUITING)
Study contacts
- Study coordinator: Mostafa Ali Hamed
- Email: mostafaalihamed97@gmail.com
- Phone: +201006850240
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Distal Ulna Fracture, Distal ulna fractures, Dual fixation