Hook Plate vs Tightrope in Fixation of Fracture Distal Third Clavicle

Not Applicable

• Conditions: Fracture Clavicle
• Interventions: Procedure: Open Reduction Internal Fixation (ORIF)

• Registration Number: NCT03773848
• Lead Sponsor: Assiut University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-12-10
• Study First Submitted QC: 2018-12-11
• Study First Posted: 2018-12-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-19
• Last Update Posted: 2019-02-21
• Study Start: 2019-06-01
• Primary Completion: 2021-01-01
• Study Completion: 2021-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A- hook plate	Open Reduction Internal Fixation (ORIF)	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.
B- tightrope	Open Reduction Internal Fixation (ORIF)	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.

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
Fracture Healing	at 6 weeks & 6 months post-operatively.	Radiological evaluation of the fracture by using antero-posterior and axillary views x-ray
Skin condition	at 6 weeks	Evaluation of skin condition of the surgical incision by clinical inspection
Radiation time	Intra-operatively	Calculation of the exposure time to radiations during surgery in minutes.
Blood loss	Intra-operatively	Recording of the blood loss amount during surgery in milliliters.