Benefit of Surgical Hardware Removal Following Clavicle Fracture

Technical University of Munich

Status: Completed

Conditions: Clavicle Fracture

Treatments: Procedure: Hardware Removal

Study type: Observational

Funder types: Other

Identifiers

NCT04343118

089_2019ME

Details and patient eligibility

About

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

Full 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).

Enrollment: 30 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 1 patient group

Group Removal

Description:

All patient receiving surgical removal of plate osteosynthesis

Treatment:

Procedure: Hardware Removal