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

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.

Study Overview

• Status: Recruiting
• Conditions: Fixation of Displaced Distal Ulna Fractures in Adults by Flexible Intramedullary Nail
• Intervention / Treatment: Device: 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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mahmoud Hassan, Elsayed; Phone Number: 00201009680600; Email: orthopedicman600@gmail.com

Study Locations

• Egypt
  • Sohag, Egypt, 82515
    • Recruiting
    • Sohag University Hospital
    • Contact: Elshazly Mosa, Professor of Orthopaedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Adult with fracture distal ulna	Device: Flexible intramedullary nail; Fixation of distal ulna fracture with flexible intramedullary nail

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiological evaluation	Displacement of fracture - signs of healing	Immediately postoperative
Grace and Eversmann rating system	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.	6 months postoperative
Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire scores	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	6 months postoperative
Radiological evaluation	Displacement of fracture - signs of healing	2 weeks postoperative
Radiological evaluation	Displacement of fracture - signs of healing	1month postoperative
Radiological evaluation	Displacement of fracture - signs of healing	2 months postoperative
Radiological evaluation	Displacement of fracture - signs of healing	6 months postoperative

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• Grace TG, Eversmann WW Jr. Forearm fractures: treatment by rigid fixation with early motion. J Bone Joint Surg Am. 1980 Apr;62(3):433-8.
• Matthews LS, Kaufer H, Garver DF, Sonstegard DA. The effect on supination-pronation of angular malalignment of fractures of both bones of the forearm. J Bone Joint Surg Am. 1982 Jan;64(1):14-7.
• PATRICK J. A study of supination and pronation, with especial reference to the treatment of forearm fractures. J Bone Joint Surg Am. 1946 Oct;28(4):737-48. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2021
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): July 30, 2022

Study Registration Dates

• First Submitted: November 27, 2021
• First Submitted That Met QC Criteria: December 10, 2021
• First Posted (Actual): December 29, 2021

Study Record Updates

• Last Update Posted (Actual): December 29, 2021
• Last Update Submitted That Met QC Criteria: December 10, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Ulna Fractures
• Other Study ID Numbers: Soh-Med-21-11-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Not decided yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No