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

NCT06395363 | Completed

• 2 other identifiers: Tishreen_ Clavical fructures15
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Clavicle Fracture

Keywords

Distal clavicle fractures; TBW; Hook plate; functional outcomes

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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,

• 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.

Study Arms (2)

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.

Procedure: fixation method

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.

Procedure: fixation method

Interventions

fixation method 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; Tension Band Wiring (TBW) group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study is a comparative retrospective study of 38 patients who had unstable distal clavicle fracture (Neer 2) featured in Figure 1. treated either with TBW technique (Figure 3 and 4) or A.O Hook plate fixation (Fugure.2), and presented to the orthopedic department of Tishreen University Hospital, in Lattakia, Syria, between August 30, 2019 and August 30, 2022.

You may qualify if:

• Patients with unstable distal third clavicle fracture (Neer type 2)
• Patients aged between 18 and 65 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Tishreen University: lead

Study Sites (1)

Tishreen University

Latakia, Syria

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 2, 2024
• Study Start: August 1, 2019
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: May 2, 2024

Record last verified: 2024-04

Locations

SY (1)