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

NCT ID: NCT05173181

Last Updated: 2021-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-25

Study Completion Date

2022-07-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The investigators have only one group of patients, (Adult with isolated fracture distal ulna). The investigators will do a single intervention, (Fixation with flexible intramedullary nail).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Adult with fracture distal ulna

Group Type OTHER

Flexible intramedullary nail

Intervention Type DEVICE

Fixation of distal ulna fracture with flexible intramedullary nail

Interventions

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Flexible intramedullary nail

Fixation of distal ulna fracture with flexible intramedullary nail

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Hassan

Orthopedic Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University Hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mahmoud Hassan, Elsayed

Role: CONTACT

Phone: 00201009680600

Email: [email protected]

Facility Contacts

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Elshazly Mosa, Professor of Orthopaedics

Role: primary

References

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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.

Reference Type RESULT
PMID: 7364814 (View on PubMed)

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.

Reference Type RESULT
PMID: 7054197 (View on PubMed)

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.

Reference Type RESULT
PMID: 21003183 (View on PubMed)

Other Identifiers

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Soh-Med-21-11-08

Identifier Type: -

Identifier Source: org_study_id