NCT04343118

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 13, 2020

Completed
Last Updated

April 13, 2020

Status Verified

April 1, 2020

Enrollment Period

5 years

First QC Date

April 1, 2020

Last Update Submit

April 8, 2020

Conditions

Clavicle Fracture

Outcome Measures

Primary Outcomes (1)

  • Shoulder function

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

    6 Week post surgery

Study Arms (1)

Group Removal

All patient receiving surgical removal of plate osteosynthesis

Procedure: Hardware Removal

Interventions

Hardware RemovalPROCEDURE

elective removal of plate osteosynthesis at the clavicle

Group Removal

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients requesting implant removal

You may qualify if:

  • age \>18 years
  • Radiologically consolidated clavicle fracture
  • following ORIF using a superior anatomically preformed locking plate
  • asking for elective implant removal
  • written informed consent.

You may not qualify if:

  • Pregnancy
  • Under-aged
  • Delinquent patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar

Munich, Bavaria, 81675, Germany

Location

Related Publications (1)

  • Wurm M, Beirer M, Zyskowski M, Volk C, Schwarz A, Biberthaler P, Kirchhoff C, Cronlein M. Does implant removal of superior clavicle plate osteosynthesis affect the functional outcome: a prospective trial. Arch Orthop Trauma Surg. 2022 Jan;142(1):139-144. doi: 10.1007/s00402-020-03669-z. Epub 2020 Nov 1.

    PMID: 33130933DERIVED

MeSH Terms

Interventions

Hardware Removal

Intervention Hierarchy (Ancestors)

Device RemovalSurgical Procedures, Operative

Study Officials

  • Chlodwig Kirchhoff, MD

    Klinikum rechts der Isar, TU München

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 1, 2020

First Posted

April 13, 2020

Study Start

January 1, 2015

Primary Completion

January 1, 2020

Study Completion

January 2, 2020

Last Updated

April 13, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)