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

NCT ID: NCT06395363

Last Updated: 2024-05-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 38 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2022-08-30

Brief 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.

Detailed 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

Conditions

Clavicle Fracture

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Tension Band Wiring (TBW) group

Patients had The fixation method that involved trans-articular fixation through the acromioclavicular joint, supplemented with an additional cerclage wire tension band for enhanced stability. Following surgery, the operated shoulder was supported with a triangular sling for a period of 4 to 6 weeks. Gentle mobilization was permitted once pain subsided, although full range of motion was limited due to pin impingement until implant removal.

fixation method

Intervention Type: PROCEDURE

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.

In the Hook plate group

Patients had The fixation method that involved creating a tunnel in the sub-acromial space posterior to the acromioclavicular joint and inserting the hook into this tunnel. If necessary, the plate was contoured to match the clavicle's shape, with careful consideration given to the appropriate depth of the hook. Dynamic compression was utilized to secure the plate in place. Following surgery, the shoulder was supported with a triangular sling for a period ranging from 2 to 4 weeks. Mobilization commenced at the earliest opportunity, typically resulting in full range of motion within three to four weeks. It is worth mentioning that across both groups, heavy manual labor was prohibited until evidence of solid fracture union was observed.

fixation method

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tishreen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tishreen University

Latakia, , Syria

Countries

Syria

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

15

Identifier Type: REGISTRY

Identifier Source: secondary_id

Tishreen_ Clavical fructures

Identifier Type: -

Identifier Source: org_study_id