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OpenTrials
Completed

NCT Number: NCT04343118

Benefit of Surgical Hardware Removal Following Clavicle Fracture

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

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Key information

Conditions

Clavicle Fracture

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar

Munich, Bavaria, 81675, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hardware Removal

Procedure

elective removal of plate osteosynthesis at the clavicle

Primary outcomes

  1. Shoulder function

    Time frame: 6 Week post surgery

    Munich Shoulder Questionnaire allowing for calculation of Constant Score (0-100), Dash (0-100)

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

Do Patients Benefit From Elective Implant Removal Following Plate Osteosynthesis of Clavicle Fractures - a Prospective Trial

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Apr 13, 2020
Registry last updated
Apr 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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