Hook Plate vs Tightrope in Fixation of Fracture Distal Third Clavicle

Fracture Clavicle Clinical Trial

Official title:

Hook Plate vs Tightrope in Fixation of Fracture Distal Third Clavicle

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03773848
• Other study ID #: Hook plate vs Tightrope
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: February 1, 2021

Study information

• Verified date: February 2019
• Source: Assiut University
• Contact: David
• Phone: +201221748069
• Email: davidmounir1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fracture Clavicle
• Fractures, Bone

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

Flinkkilä T, Heikkilä A, Sirniö K, Pakarinen H. TightRope versus clavicular hook plate fixation for unstable distal clavicular fractures. Eur J Orthop Surg Traumatol. 2015 Apr;25(3):465-9. doi: 10.1007/s00590-014-1526-9. Epub 2014 Sep 9. — View Citation

Haque S, Khan A, Sharma A, Sundararajan S. Technical tip: tightrope fixation of neer type II distal clavicle fracture supported by a case series. Pol Orthop Traumatol. 2014 Mar 27;79:19-22. — View Citation

Lee W, Choi CH, Choi YR, Lim KH, Chun YM. Clavicle hook plate fixation for distal-third clavicle fracture (Neer type II): comparison of clinical and radiologic outcomes between Neer types IIA and IIB. J Shoulder Elbow Surg. 2017 Jul;26(7):1210-1215. doi: 10.1016/j.jse.2016.11.046. Epub 2017 Jan 26. — View Citation

Yan HW, Li L, Wang RC, Yang Y, Xie Y, Tang J, Shi ZY. Clinical efficacies of coracoclavicular ligament reconstruction using suture anchor versus hook plate in the treatment of distal clavicle fracture. Orthop Traumatol Surg Res. 2017 Dec;103(8):1287-1293. doi: 10.1016/j.otsr.2017.07.006. Epub 2017 Aug 8. — View Citation

Outcome

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