Hook Plate vs Tightrope in Fixation of Fracture Distal Third Clavicle

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2021-02-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Fracture Clavicle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Open Reduction Internal Fixation (ORIF)

Intervention Type PROCEDURE

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

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.

Group Type EXPERIMENTAL

Open Reduction Internal Fixation (ORIF)

Intervention Type PROCEDURE

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

Interventions

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Open Reduction Internal Fixation (ORIF)

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No