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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Flexible intramedullary nail
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fixation of Displaced Distal Ulna Fractures in Adults by Flexible Intramedullary Nail

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sohag University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Adult with fracture distal ulna

Arm Description

Outcomes

Primary Outcome Measures

Radiological evaluation
Displacement of fracture - signs of healing
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.
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
Radiological evaluation
Displacement of fracture - signs of healing
Radiological evaluation
Displacement of fracture - signs of healing
Radiological evaluation
Displacement of fracture - signs of healing
Radiological evaluation
Displacement of fracture - signs of healing

Secondary Outcome Measures

Full Information

First Posted
November 27, 2021
Last Updated
December 10, 2021
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05173181
Brief Title
Fixation of Displaced Distal Ulna Fractures in Adults by Flexible Intramedullary Nail
Official Title
Fixation of Displaced Distal Ulna Fractures in Adults by Flexible Intramedullary Nail
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Anticipated)
Study Completion Date
July 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fixation of Displaced Distal Ulna Fractures in Adults by Flexible Intramedullary Nail

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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).
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adult with fracture distal ulna
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Flexible intramedullary nail
Intervention Description
Fixation of distal ulna fracture with flexible intramedullary nail
Primary Outcome Measure Information:
Title
Radiological evaluation
Description
Displacement of fracture - signs of healing
Time Frame
Immediately postoperative
Title
Grace and Eversmann rating system
Description
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.
Time Frame
6 months postoperative
Title
Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire scores
Description
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
Time Frame
6 months postoperative
Title
Radiological evaluation
Description
Displacement of fracture - signs of healing
Time Frame
2 weeks postoperative
Title
Radiological evaluation
Description
Displacement of fracture - signs of healing
Time Frame
1month postoperative
Title
Radiological evaluation
Description
Displacement of fracture - signs of healing
Time Frame
2 months postoperative
Title
Radiological evaluation
Description
Displacement of fracture - signs of healing
Time Frame
6 months postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Hassan, Elsayed
Phone
00201009680600
Email
orthopedicman600@gmail.com
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
ZIP/Postal Code
82515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elshazly Mosa, Professor of Orthopaedics

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Not decided yet
Citations:
PubMed Identifier
7364814
Citation
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.
Results Reference
result
PubMed Identifier
7054197
Citation
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.
Results Reference
result
PubMed Identifier
21003183
Citation
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.
Results Reference
result

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

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