Benefit of Surgical Hardware Removal Following Clavicle Fracture

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2020-01-02

Brief Summary

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

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Detailed Description

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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).

Conditions

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Clavicle Fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group Removal

All patient receiving surgical removal of plate osteosynthesis

Hardware Removal

Intervention Type PROCEDURE

elective removal of plate osteosynthesis at the clavicle

Interventions

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Hardware Removal

elective removal of plate osteosynthesis at the clavicle

Intervention Type PROCEDURE

Eligibility Criteria

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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.