Benefit of Surgical Hardware Removal Following Clavicle Fracture

Completed

• Conditions: Clavicle Fracture
• Interventions: Procedure: Hardware Removal

• Registration Number: NCT04343118
• Lead Sponsor: Technical University of Munich

Brief Summary

Little is known about the beneficial aspects of elective implant removal following plate osteosynthesis of displaced clavicle fractures.

Detailed Description

Elective implant removal accounts for up to 30% of all orthopaedic surgeries. While there is general acceptance about the need of implant removal for obvious reasons, such as infections or implant failure, little is known about the beneficial aspects in cases of minor reasons. Therefore, we initiated this study to define patients' benefit of elective implant removal following plate osteosynthesis of displaced clavicle fractures.

Patients and Methods Prospective evaluation of patients was conducted before implant removal and 6 weeks postoperative. Subjective and objective criteria included patients' satisfaction, pain rating on a visual analog scale (VAS) and active range of motion (ROM) pre- and 6 weeks postoperative. Functional scoring included the SPADI, DASH score, the Constant Score and the Munich Shoulder Questionnaire (MSQ).

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-02
• Status Verified: 2020-04
• Study First Submitted: 2020-04-01
• Study First Submitted QC: 2020-04-08
• Last Update Submitted: 2020-04-08
• Study First Posted: 2020-04-13
• Last Update Posted: 2020-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• age >18 years
• Radiologically consolidated clavicle fracture
• following ORIF using a superior anatomically preformed locking plate
• asking for elective implant removal
• written informed consent.

Exclusion Criteria

• Pregnancy
• Under-aged
• Delinquent patients.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group Removal	Hardware Removal	All patient receiving surgical removal of plate osteosynthesis

Primary Outcome Measures

Name	Time	Method
Shoulder function	6 Week post surgery	Munich Shoulder Questionnaire allowing for calculation of Constant Score (0-100), Dash (0-100)

Trial Locations

Locations (1)

Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar; 🇩🇪 Munich, Bavaria, Germany