Evaluation of the Functional Outcomes of Surgical Treatment in Displaced, Closed, and Isolated Distal Clavicle Fractures in Adults

Clavicle Fracture Clinical Trial

— clavicle_fruc  

Official title:

Evaluation of the Functional Outcomes of Surgical Treatment in Displaced, Closed, and Isolated Distal Clavicle Fractures in Adults, A Comparative Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06395363
• Other study ID #: Tishreen_ Clavical fructures
• Secondary ID: 15
• Status: Completed
• Start date: August 1, 2019
• Est. completion date: August 30, 2022

Study information

• Verified date: April 2024
• Source: Tishreen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Clavicle fractures are common among young people, generally as a consequence of car accidents, bike falls, and contact sports injuries. 15-20% of all clavicle fractures involve the lateral end of the bone. Thus, the distal clavicle fractures, in particular, have a high nonunion rate ranging from 21-33% when treated non-operatively, underscoring the usual advice for operative treatment. While significant research has been conducted on clavicle fractures and their treatment options, no definitive guidelines or optimal approaches have been established. Hence, this study aimed at assessing the clinical and radiological results of the two highly used surgical techniques, the Tension Band Wiring (TBW) and Hook plate ones, in addition to investigating the associated functional recovery and outcomes.

Description:

Clavicle fractures are common among young people, generally as a consequence of car accidents, bike falls, and contact sports injuries. 15-20% of all clavicle fractures involve the lateral end of the bone. Thus, the distal clavicle fractures, in particular, have a high nonunion rate ranging from 21-33% when treated non-operatively, underscoring the usual advice for operative treatment. While significant research has been conducted on clavicle fractures and their treatment options, no definitive guidelines or optimal approaches have been established. Hence, this study aimed to assess the clinical and radiological results of the two highly used surgical techniques, Tension Band Wiring (TBW) and Hook plate ones, in addition to investigating the associated functional recovery and outcomes.

Between August 2019 and 2022, An analytical retrospective comparative study was done on 38 patients (20 TBW and 18 Hook plate) diagnosed with a fracture of the lateral third of clavicle (Neer 2) and followed up for more than 12 months at Tishreen University Hospital, Lattakia, Syria.

This research study included patients who met the following criteria: Patients with unstable distal third clavicle fracture (Neer type 2), aged between 18 and 65 years old. Nevertheless, Patients who had open fractures, pathological fractures, fractures associated with brachial plexus or pulmonary or vascular injury, acromioclavicular joint disruption, and musculoskeletal disease that affects the joint, were excluded.

Preoperative shoulder x-rays in AP with (10-15) ° cephalic tilt (ZANCA View) and axillary view were taken. In addition, Basic lab tests were done for all patients on admission. this study used A.O Hook plate with (4-7) holes, (3.5) mm screws, and (12.15.18) mm of hook depth, 2 Kirschner-wires of (2.0) mm, and a stainless steel wire of (18) gauge in the TBW technique.

Furthermore, Radiological assessment was performed immediately after surgery, followed by evaluations at 3, 6, 12, and 24-week intervals to monitor healing progress and implant positioning. Recorded complications included infection, non-union, mal-union, pin migration, hardware impingement, and stiffness. The outcome was assessed based on union status, time to fracture union, shoulder joint range of motion, ability to perform daily activities and return to pre-injury status

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with unstable distal third clavicle fracture (Neer type 2)

• Patients aged between 18 and 65 years old

Exclusion Criteria:

• Patient who had open fractures, pathological fractures, fractures associated with brachial plexus or pulmonary or vascular injury, acromioclavicular joint disruption, and musculoskeletal disease that affects the joint

Related Conditions & MeSH terms

• Clavicle Fracture
• Fractures, Bone

Intervention

Procedure:
• fixation method
The fixation methods were either involved trans-articular fixation through the acromioclavicular joint, supplemented with an additional cerclage wire tension band for enhanced stability. Or, creating a tunnel in the sub-acromial space posterior to the acromioclavicular joint and inserting the hook into this tunnel.

Locations

Country	Name	City	State
Syrian Arab Republic	Tishreen University	Latakia

Sponsors (1)

Lead Sponsor	Collaborator
Tishreen University

Country where clinical trial is conducted

Syrian Arab Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Rate of Wound infection	Wound infection refers to the occurrence of microbial contamination or colonization leading to clinical signs and symptoms of infection at the surgical site. It encompasses various types of infections, including superficial, deep, and organ/space surgical site infections, as defined by the Centers for Disease Control and Prevention (CDC) criteria.	Estimated time is up to 6 weeks, follow-up visits typically at 2 weeks, 4 weeks, and 6 weeks post-surgery.
Primary	The Rate of wire migration	The rate of wire migration refers to the occurrence of movement or displacement of wires used in surgical procedures, particularly those intended for fixation or support, Wire migration can lead to various complications depending on the location and purpose of the wire, including malpositioning, tissue damage, or loss of efficacy in providing support or stabilization.	Up to 12 months, Regular monitoring of wire stability and migration during scheduled follow-up visits, typically conducted monthly for the duration of the study.
Primary	The incidence of sub-acromial impingement	Sub-acromial impingement syndrome is a common shoulder disorder characterized by compression or irritation of the structures located beneath the acromion, including the rotator cuff tendons and sub-acromial bursa.	Continued monitoring of shoulder function and pain at intermediate time points during the study, up to 12 months post-treatment,
Primary	The Rate of Skin erosion	Skin erosion refers to the gradual wearing away or breakdown of the skin surface, leading to the exposure of underlying tissues.skin erosion may occur as a result of various factors, including the type of medical device or implant used, repeated friction or pressure on the skin, or underlying infection. Monitoring skin erosion is important as it can indicate potential complications related to the intervention, such as device failure, tissue irritation, or infection.	Continued monitoring immediate post-intervention period up to 12 months post operatively.