NCT05687734

Brief Summary

The aim of the study is to evaluate the results of reconstruction of neglected and failed cases of terrible triad of the elbow

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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Status
unknown

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

December 15, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

1.7 years

First QC Date

December 15, 2022

Last Update Submit

January 15, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • The final end results will be assessed according to degree of improvement according to DASH score performance index

    The final end results will be assessed according to degree of improvement according to DASH score performance index (The disability of the arm, shoulder and hand)(is an upper-extremity specific outcome measure that was introduced by the American Academy of Orthopedic Surgeons in collaboration with a number of other organizations)(The main part of the DASH is a 30-item disability/symptom scale concerning the patient's health status during the preceding week. The items ask about the degree of difficulty in performing different physical activities because of the arm, shoulder, or hand problem (21 items), the severity of each of the symptoms of pain, activity-related pain, tingling, weakness and stiffness (5 items), as well as the problem's impact on social activities, work, sleep, and self-image (4 items). Each item has five response options. The scores for all items are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability).

    DASH score assessment preoperative and at 4,8 weeks 6 months and 1 year postoperative.Follow up:2 weeks postoperative for stitches removal, 6 weeks by x ray to assess reunion, 3 and 6 months by x ray to assess reunion.1 year by MSCT to assess reunion

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

• All cases fulfilling the Inclusion and Exclusion Criteria admitted to Assuit university over two year from the beginning of the study.

You may qualify if:

  • Age from 15 to 70 years' old
  • Neglected cases more than 4 weeks
  • Early failed cases whom had any intervention whether conservative treatment as cast or hinged elbow brace etc or operative and still complaining of instability of the elbow. In less than 6 weeks
  • Late Failed cases whom had any intervention whether conservative treatment as cast or hinged elbow brace etc or operative and still complaining of instability of the elbow after more than 6 weeks .

You may not qualify if:

  • Older than 70 years old and younger than 15 years old
  • Nerve injury
  • Associated soft tissue loss
  • Patients needs Total Elbow Replacement or Arthrodesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Kachooei AR, Mellema JJ, Tarabochia MA, Chen N, van Dijk CN, Ring D. Involvement of the lesser sigmoid notch in elbow fracture dislocations. J Shoulder Elbow Surg. 2016 Oct;25(10):1571-6. doi: 10.1016/j.jse.2016.02.013. Epub 2016 May 24.

    PMID: 27233485BACKGROUND
  • Giannicola G, Calella P, Piccioli A, Scacchi M, Gumina S. Terrible triad of the elbow: is it still a troublesome injury? Injury. 2015 Dec;46 Suppl 8:S68-76. doi: 10.1016/S0020-1383(15)30058-9.

    PMID: 26747922BACKGROUND
  • Zhang J, Tan M, Kwek EBK. Outcomes of coronoid-first repair in terrible triad injuries of the elbow. Arch Orthop Trauma Surg. 2017 Sep;137(9):1239-1245. doi: 10.1007/s00402-017-2733-8. Epub 2017 Jun 20.

    PMID: 28634742BACKGROUND
  • Fitzgibbons PG, Louie D, Dyer GS, Blazar P, Earp B. Functional outcomes after fixation of "terrible triad" elbow fracture dislocations. Orthopedics. 2014 Apr;37(4):e373-6. doi: 10.3928/01477447-20140401-59.

    PMID: 24762843BACKGROUND
  • Ritali A, Rotini R, Cavallo M, Marinelli A, Guerra E. Instability/stiffness in elbow fracture dislocation. Lo Scalpello-Journal. 2020 Mar 22;34:30-5.

    BACKGROUND
  • Sun Z, Li J, Luo G, Wang F, Hu Y, Fan C. What constitutes a clinically important change in Mayo Elbow Performance Index and range of movement after open elbow arthrolysis? Bone Joint J. 2021 Feb;103-B(2):366-372. doi: 10.1302/0301-620X.103B2.BJJ-2020-0259.R3.

    PMID: 33517717BACKGROUND

MeSH Terms

Conditions

Elbow Injuries

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and Injuries

Study Officials

  • Aly Mohamden Mohamed, Professor

    Assiut University

    STUDY DIRECTOR
  • Waleed Riad Saleh, Professor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Momen Moustafa Mohamed, specialist

CONTACT

Ayman Farouk Abdelkawi, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

December 15, 2022

First Posted

January 18, 2023

Study Start

March 1, 2023

Primary Completion

October 30, 2024

Study Completion

December 30, 2024

Last Updated

January 18, 2023

Record last verified: 2023-01