Hook Plate vs Tightrope in Fixation of Fracture Distal Third Clavicle

Assiut University

Status: Unknown

Conditions: Fracture Clavicle

Treatments: Procedure: Open Reduction Internal Fixation (ORIF)

Study type: Interventional

Funder types: Other

Identifiers

NCT03773848

Hook plate vs Tightrope

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

30 participants in 2 patient groups

A- hook plate

Experimental group

Description:

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.

Treatment:

Procedure: Open Reduction Internal Fixation (ORIF)

B- tightrope

Experimental group

Description:

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.

Treatment:

Procedure: Open Reduction Internal Fixation (ORIF)