NCT03773848

Brief Summary

to compare the clinical \& radiological outcomes of hook plate \& tightrope fixation in fracture of lateral third clavicle.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

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 10, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

February 21, 2019

Status Verified

February 1, 2019

Enrollment Period

1.6 years

First QC Date

December 10, 2018

Last Update Submit

February 19, 2019

Conditions

Fracture Clavicle

Outcome Measures

Primary Outcomes (1)

  • Improvement of limb function this change will be assessed using Disabilities of the Arm, Shoulder and Hand (DASH) Score as limb function will be expected of some movement limitation at 6 weeks and no limitations to be at 6 months

    The DASH is a self-administered questionnaire that consists of thirty core questions and an optional additional eight questions assessing work and sports and/or performing arts activities. Each individual item is scored on a 5-point Likert scale, with lower scores correlating to minimal impairment and higher scores indicating more impairment. The cumulative DASH score is scaled from 0 to 100, with higher scores indicating more disability

    at 6 weeks & 6 months post-operatively.

Secondary Outcomes (4)

  • Fracture Healing

    at 6 weeks & 6 months post-operatively.

  • Blood loss

    Intra-operatively

  • Radiation time

    Intra-operatively

  • Skin condition

    at 6 weeks

Study Arms (2)

A- hook plate

EXPERIMENTAL

All participants will have an Open Reduction Internal Fixation (ORIF). The affected upper limb will be temporarily fixed by a sling after admission. The patients will be placed in a beach-chair position in an orthopaedic theatre. The operated side will be prepped and draped and a transverse incision will be made over the fracture site. The fracture ends will be identified, reduced and fixed with hook plate. X-ray was applied to check the grade of reduction before the operation is completed.

Procedure: Open Reduction Internal Fixation (ORIF)

B- tightrope

EXPERIMENTAL

All participants will have an Open Reduction Internal Fixation (ORIF). The affected upper limb will be temporarily fixed by a sling after admission. The patients will be placed in a beach-chair position in an orthopaedic theatre. The operated side will be prepped and draped and a transverse incision will be made over the fracture site. The fracture ends will be identified, reduced and fixed with tightrope. X-ray was applied to check the grade of reduction before the operation is completed.

Procedure: Open Reduction Internal Fixation (ORIF)

Interventions

Open Reduction Internal Fixation (ORIF)PROCEDURE

Open Reduction Internal Fixation (ORIF) of fracture lateral third clavicle by hook plate \& tightrope

A- hook plateB- tightrope

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (over 16 years old) including both sexes.
  • Acute fractures within 3 weeks of injury.
  • Isolated \& closed fractures.

You may not qualify if:

  • Pathological fracture of distal clavicle.
  • Deteriorated general health.
  • Previous history of dysfunction with the affected shoulder.
  • Incomplete medical records or lost to follow up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Flinkkila T, Heikkila A, Sirnio K, Pakarinen H. TightRope versus clavicular hook plate fixation for unstable distal clavicular fractures. Eur J Orthop Surg Traumatol. 2015 Apr;25(3):465-9. doi: 10.1007/s00590-014-1526-9. Epub 2014 Sep 9.

    PMID: 25200315BACKGROUND

  • Haque S, Khan A, Sharma A, Sundararajan S. Technical tip: tightrope fixation of neer type II distal clavicle fracture supported by a case series. Pol Orthop Traumatol. 2014 Mar 27;79:19-22.

    PMID: 24675020BACKGROUND

  • Lee W, Choi CH, Choi YR, Lim KH, Chun YM. Clavicle hook plate fixation for distal-third clavicle fracture (Neer type II): comparison of clinical and radiologic outcomes between Neer types IIA and IIB. J Shoulder Elbow Surg. 2017 Jul;26(7):1210-1215. doi: 10.1016/j.jse.2016.11.046. Epub 2017 Jan 26.

    PMID: 28131682BACKGROUND

  • Yan HW, Li L, Wang RC, Yang Y, Xie Y, Tang J, Shi ZY. Clinical efficacies of coracoclavicular ligament reconstruction using suture anchor versus hook plate in the treatment of distal clavicle fracture. Orthop Traumatol Surg Res. 2017 Dec;103(8):1287-1293. doi: 10.1016/j.otsr.2017.07.006. Epub 2017 Aug 8.

    PMID: 28801112BACKGROUND

Central Study Contacts

David

CONTACT

+201221748069davidmounir1@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 10, 2018

First Posted

December 12, 2018

Study Start

June 1, 2019

Primary Completion

January 1, 2021

Study Completion

February 1, 2021

Last Updated

February 21, 2019

Record last verified: 2019-02