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Clinical Trials/NCT05173181
NCT05173181UnknownNot Applicable

Fixation of Displaced Distal Ulna Fractures in Adults by Flexible Intramedullary Nail

Sohag University1 site in 1 country30 target enrollmentStarted: November 25, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
30
Locations
1
Primary Endpoint
Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire scores

Study Overview

Brief Summary

The distal ulna is an important weight-bearing component of the wrist joint and an essential element of the forearm articulation. After injury, significant residual malalignment or deformity of the distal ulna and deficiency of its ligamentous support have a deleterious effect on grip strength and forearm rotation.

Although the best treatment option for displaced distal ulnar fracture remains a subject of debate, most surgeons aim for anatomical reduction and stable fixation to avoid disruption of the distal radioulnar joint.

The investigators will assess clinical and radiological results of fixation of displaced distal ulna fractures in adults by flexible intramedullary nail.

Detailed Description

The distal ulna is an important weight-bearing component of the wrist joint and an essential element of the forearm articulation. After injury, significant residual malalignment or deformity of the distal ulna and deficiency of its ligamentous support have a deleterious effect on grip strength and forearm rotation.

Fractures of the distal ulna usually occur in association with distal radius fractures.

Isolated distal ulnar fracture is an uncommon upper limb injury. It is usually the consequence of a direct blow against the soft tissue-deficient ulnar border.

Injuries to the distal ulna can lead to derangement of the distal radioulnar joint (DRUJ), subsequently resulting in pain from incongruity or ulnocarpal impaction, limitation of forearm rotation due to scarring, and weakness secondary to instability of the joint under load.

Isolated fractures of the distal third of the ulnar shaft can be treated successfully by conservative if not significantly displaced and if rotational malalignment is not present. Fractures with significant displacement or those with rotational malalignment (displaced spiral fracture patterns) are best be treated by osteosynthesis and functional rehabilitation in order to prevent loss of forearm rotation.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
16 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients with displaced distal ulna fractures in adult patient admitted in orthopaedic department of Sohag University Hospital after taking an informed consent from patients or near relatives

Exclusion Criteria

  • •Patients with Intra articular fractures
  • •Fractures with disturbed radioulnar joint
  • •Old malunited or deformed distal ulna

Arms & Interventions

Adult with fracture distal ulna

Other

Intervention: Flexible intramedullary nail (Device)

Outcomes

Primary Outcomes

Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire scores

Time Frame: 6 months postoperative

Self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100

Radiological evaluation

Time Frame: 6 months postoperative

Displacement of fracture - signs of healing

Grace and Eversmann rating system

Time Frame: 6 months postoperative

Rating system that was based only on fracture union and pronation-supination of the forearm. Motion of the wrist and elbow was not used in the rating system, 10 means excellent results 4 means acceptable results.

Radiological evaluation

Time Frame: Immediately postoperative

Displacement of fracture - signs of healing

Radiological evaluation

Time Frame: 2 weeks postoperative

Displacement of fracture - signs of healing

Radiological evaluation

Time Frame: 1month postoperative

Displacement of fracture - signs of healing

Radiological evaluation

Time Frame: 2 months postoperative

Displacement of fracture - signs of healing

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mahmoud Hassan

Orthopedic Resident

Sohag University

Study Sites (1)

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