Benefit of Surgical Hardware Removal Following Clavicle F... | NCT04343118

Studies
Benefit of Surgical Hardware Removal Following Clavicle Fracture

NCT04343118

Sponsor

Technical University of Munich

Status

Completed

Last Update Posted

Apr 13, 2020Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Clavicle Fracture

Interventions

Hardware Removal

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2015Actual

Primary Completion Date

Jan 1, 2020Actual

Completion Date

Jan 2, 2020Actual

First Submitted Date

Apr 1, 2020

First Submission Date that Met QC Criteria

Apr 8, 2020

First Posted Date

Apr 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2020

Last Update Posted Date

Apr 13, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Chlodwig Kirchhoff, Clinical Professor, Technical University of MunichPrincipal Investigator

Lead Sponsor

Technical University of MunichOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group Removal		All patient receiving surgical removal of plate osteosynthesis	Procedure: Hardware Removal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hardware Removal	Procedure	elective removal of plate osteosynthesis at the clavicle	Group Removal

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patients requesting implant removal

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chlodwig Kirchhoff, MD	Klinikum rechts der Isar, TU München	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar		Munich	Bavaria	81675	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33130933	Derived	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.

ID	Term
D020878	Device Removal
D013514	Surgical Procedures, Operative