Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hook Plate vs Tightrope in Fixation of Fracture Distal Third Clavicle

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03773848
Recruitment Status : Not yet recruiting
First Posted : December 12, 2018
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
David Mounir Kamal Ibrahim, Assiut University

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

Condition or disease Intervention/treatment Phase
Fracture Clavicle Procedure: Open Reduction Internal Fixation (ORIF) Not Applicable

Detailed Description:

Adult clavicle fractures account for 4% to 10% of fractures. Distal clavicle fractures occurs in 25% to 30% of all clavicle fracture.The management of fractures of the distal clavicle has been a matter of debate in literature. Neer in 1968 suggested a new classification and proposed general treatment guidelines . Type I and type III fractures are generally treated non-operatively. For type II fractures, surgical management is the treatment of choice .There are numerous operative techniques reported in the past. The methods of surgical treatment could be summarised as follows:

  1. Fixation in terms of K-wires and different pins such as the Steinmann pin, and Knowles pin. This fixation could also be augmented with concomitant tension band wires
  2. Coracoclavicular indirect fixation with the use of screws, suture anchors, Dacron graft or Mersilene tape
  3. Open reduction and clavicular plate fixation with the use of different plate systems such as the Balser plate,locked plate,hook plate, etc.

Different surgical techniques have their own advantages and disadvantages With more than 20 techniques described so far, no single fixation is ideal and perfect. There is still no consensus regarding the best surgical method to fix these fracture ,the investigators choose two of the most common of these methods and evaluate & compare best radiological & clinical outcomes of both.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Hook Plate vs Tightrope in Fixation of Fracture Distal Third Clavicle
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: A- hook plate
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)
Open Reduction Internal Fixation (ORIF) of fracture lateral third clavicle by hook plate & tightrope

Experimental: B- tightrope
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)
Open Reduction Internal Fixation (ORIF) of fracture lateral third clavicle by hook plate & tightrope




Primary Outcome Measures :
  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 [ Time Frame: at 6 weeks & 6 months post-operatively. ]
    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


Secondary Outcome Measures :
  1. Fracture Healing [ Time Frame: at 6 weeks & 6 months post-operatively. ]
    Radiological evaluation of the fracture by using antero-posterior and axillary views x-ray

  2. Blood loss [ Time Frame: Intra-operatively ]
    Recording of the blood loss amount during surgery in milliliters.

  3. Radiation time [ Time Frame: Intra-operatively ]
    Calculation of the exposure time to radiations during surgery in minutes.

  4. Skin condition [ Time Frame: at 6 weeks ]
    Evaluation of skin condition of the surgical incision by clinical inspection



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773848


Contacts
Layout table for location contacts
Contact: David +201221748069 davidmounir1@gmail.com

Sponsors and Collaborators
Assiut University
Publications:
Layout table for additonal information
Responsible Party: David Mounir Kamal Ibrahim, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03773848    
Other Study ID Numbers: Hook plate vs Tightrope
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Fractures, Bone
Wounds and Injuries