Benefit of Surgical Hardware Removal Following Clavicle Fracture

Clavicle Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04343118
• Other study ID #: 089_2019ME
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: January 2, 2020

Study information

• Verified date: April 2020
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Clavicle Fracture
• Fractures, Bone

Intervention

Procedure:
• Hardware Removal
elective removal of plate osteosynthesis at the clavicle

Locations

Country	Name	City	State
Germany	Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder function	Munich Shoulder Questionnaire allowing for calculation of Constant Score (0-100), Dash (0-100)	6 Week post surgery