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Benefit of Surgical Hardware Removal Following Clavicle Fracture

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04343118
Enrollment
30
Registered
2020-04-13
Start date
2015-01-01
Completion date
2020-01-02
Last updated
2020-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clavicle Fracture

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).

Interventions

elective removal of plate osteosynthesis at the clavicle

Sponsors

Technical University of Munich
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Shoulder function6 Week post surgeryMunich Shoulder Questionnaire allowing for calculation of Constant Score (0-100), Dash (0-100)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026