Clinical trial NCT03773848: Hook Plate vs Tightrope in Fixation of Fracture Distal Third Clavicle
Official title: Hook Plate vs Tightrope in Fixation of Fracture Distal Third Clavicle
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fracture Clavicle
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: at 6 weeks & 6 months post-operatively.
Secondary outcomes:
measure: Fracture Healing
timeFrame: at 6 weeks & 6 months post-operatively.
measure: Blood loss
timeFrame: Intra-operatively
measure: Radiation time
timeFrame: Intra-operatively
measure: Skin condition
timeFrame: at 6 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Flinkkila T, Heikkila A, Sirnio 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.
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.
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.
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.