NCT05982327

Brief Summary

Assessment of functional outcome of operative management of scapular fractures through Arabic version DASH score

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

April 5, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

9 months

First QC Date

July 19, 2023

Last Update Submit

March 23, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of functional outcome

    Arabic version DASH score

    6 week

Secondary Outcomes (3)

  • Range of motion

    Six months

  • Strength of shoulder muscle

    Six months

  • Union rate

    Six months

Interventions

ORIFPROCEDURE

fixation of scapular fractures by plate and screws

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patients who meets the inclusion criteria and agrees to be involved in our study will do: 1. Preoperative assessment: 1. Examination : Neurological and Vascular examination 2. Imaging: * Plain X- ray (True AP - Scapula Y view ) and Plain X-ray (True AP )of contralateral side Measurement of Glenopolar angle (GPA) * CT scan 2. Intra-operative assessment: a. Selection of approach. b.Postion C.Type of osteosynthesis d. Blood loss e. Radiation exposure.

You may qualify if:

  • All patient presented with scapular fractures more than 18 years old involving body, neck and glenoid 2.Intraarticular glenoid fractures with step-off \>4 mm 3.\>20% of the joint is involved and Fragment large enough to be hold by lag screw.

You may not qualify if:

  • Low demanded patients:Age \>65 yrs . 2.Scapular fractures of acromion and coracoid process and Osteoporotic fractures .
  • Scapular fractures associated with brain injuries cervical spine injuries and brachial plexus injuries.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Ideberg R, Grevsten S, Larsson S. Epidemiology of scapular fractures. Incidence and classification of 338 fractures. Acta Orthop Scand. 1995 Oct;66(5):395-7. doi: 10.3109/17453679508995571.

  • Voleti PB, Namdari S, Mehta S. Fractures of the scapula. Adv Orthop. 2012;2012:903850. doi: 10.1155/2012/903850. Epub 2012 Nov 20.

  • McGahan JP, Rab GT, Dublin A. Fractures of the scapula. J Trauma. 1980 Oct;20(10):880-3. doi: 10.1097/00005373-198010000-00011.

  • Zelle BA, Pape HC, Gerich TG, Garapati R, Ceylan B, Krettek C. Functional outcome following scapulothoracic dissociation. J Bone Joint Surg Am. 2004 Jan;86(1):2-8. doi: 10.2106/00004623-200401000-00002.

  • Brown CV, Velmahos G, Wang D, Kennedy S, Demetriades D, Rhee P. Association of scapular fractures and blunt thoracic aortic injury: fact or fiction? Am Surg. 2005 Jan;71(1):54-7.

  • Lantry JM, Roberts CS, Giannoudis PV. Operative treatment of scapular fractures: a systematic review. Injury. 2008 Mar;39(3):271-83. doi: 10.1016/j.injury.2007.06.018. Epub 2007 Oct 4.

  • Kannan S, Singh HP, Pandey R. A systematic review of management of scapular fractures. Acta Orthop Belg. 2018 Dec;84(4):497-508.

  • Mayo KA, Benirschke SK, Mast JW. Displaced fractures of the glenoid fossa. Results of open reduction and internal fixation. Clin Orthop Relat Res. 1998 Feb;(347):122-30.

Study Officials

  • Ahmed Elbadry Mahmoud, Resident

    Assiut University

    PRINCIPAL INVESTIGATOR
  • Aly Mohamadean, Prof Dr

    Assiut University

    STUDY DIRECTOR
  • Mahmoud Badran, Ass.prof

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Ahmed Elbadry Mahmoud, Resident

CONTACT

Mahmoud Badran, Ass prof

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assuit lecturer

Study Record Dates

First Submitted

July 19, 2023

First Posted

August 8, 2023

Study Start

April 5, 2024

Primary Completion

January 1, 2025

Study Completion

March 1, 2025

Last Updated

March 26, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share