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

Not Applicable

• Conditions: Fixation of Displaced Distal Ulna Fractures in Adults by Flexible Intramedullary Nail
• Interventions: Device: Flexible intramedullary nail

• Registration Number: NCT05173181
• Lead Sponsor: Sohag University

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.

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 aim is to assess clinical and radiological results of fixation of displaced distal ulna fractures in adults by flexible intramedullary nail.

It is a prospective study 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. Fractures will be managed using flexible intra medullary nail .

Patients with Intra articular fractures , Fractures with disturbed radioulnar joint , or Old malunited or deformed distal ulna are excluded.

* Clinical evaluation of patient by Grace and Eversmann rating system used to assess functional evaluation ,VAS (visual analogue scale),or Dash score (Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire scores).

* Radiological evaluation as plain x ray.

Time plan : clinical and radiolodical evaluation as follow:

* Immediately postoperative.

* 2 weeks postoperative.

* 1month postoperative.

* 2 months postoperative.

* 6 months postoperative.

Study Timeline

• Study Start: 2021-11-25
• Study First Submitted: 2021-11-27
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-10
• Last Update Submitted: 2021-12-10
• Study First Posted: 2021-12-29
• Last Update Posted: 2021-12-29
• Primary Completion: 2022-02-01
• Study Completion: 2022-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adult with fracture distal ulna	Flexible intramedullary nail	-

Primary Outcome Measures

Name	Time	Method
Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire scores	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	6 months postoperative	Displacement of fracture - signs of healing
Grace and Eversmann rating system	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.

Trial Locations

Locations (1)

Sohag University Hospital; 🇪🇬 Sohag, Egypt