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Hook Plate vs Tightrope in Fixation of Fracture Distal Third Clavicle

Hook Plate vs Tightrope in Fixation of Fracture Distal Third Clavicle

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03773848
Enrollment
30
Registered
2018-12-12
Start date
2019-06-01
Completion date
2021-02-01
Last updated
2019-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fracture Clavicle

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.

Interventions

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 monthsat 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

MeasureTime frameDescription
Fracture Healingat 6 weeks & 6 months post-operatively.Radiological evaluation of the fracture by using antero-posterior and axillary views x-ray
Blood lossIntra-operativelyRecording of the blood loss amount during surgery in milliliters.
Radiation timeIntra-operativelyCalculation of the exposure time to radiations during surgery in minutes.
Skin conditionat 6 weeksEvaluation of skin condition of the surgical incision by clinical inspection

Contacts

Primary ContactDavid
davidmounir1@gmail.com+201221748069

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026