Outcome Following Semitubular Plate vs. Polyaxial Locking... | NCT04370561

Studies
Outcome Following Semitubular Plate vs. Polyaxial Locking Plates

NCT04370561

Sponsor

Technical University of Munich

Status

Completed

Last Update Posted

May 5, 2020Actual

Enrollment

45Actual

Phase

Not Applicable

Conditions

Ankle Fractures

Interventions

ORIF non-locking
ORIF locking

Countries

Not provided

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

May 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, 2016Actual

Primary Completion Date

Jan 1, 2018Actual

Completion Date

Jan 1, 2019Actual

First Submitted Date

Apr 20, 2020

First Submission Date that Met QC Criteria

Apr 28, 2020

First Posted Date

May 1, 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

May 1, 2020

Last Update Posted Date

May 5, 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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this prospective study, all patients with distal fibula fractures (AO 44 B1.1, B1.2, B1.3), with indication for surgery were included. Patients were randomized to either the DePuy Synthes® one-third semitubular plate (Group I) or NEWCLIP TECHNICS, Active Ankle® polyaxial locking plate (Group II). In Group II early weight bearing was allowed after two weeks postoperatively. Primary outcome parameter was function of the ankle joint, assessed by the Olerud and Molander ankle score (OMAS), Foot and Ankle outcome score (FAOS) and Karlsson and Peterson Scoring System for Ankle function (KPSS). Secondary outcome parameter were postoperative complications. Superficial wound infection, delayed wound healing, mechanically prominent implant, skin irritations were considered as minor and deep wound infection, material loosening, loss of reduction were regarded as major complications requiring revision surgery. Clinical and radiological follow-up were performed 6 and 12 weeks, 6 months and 1 year postoperatively.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1/3 tubular plate	Active Comparator	Standard care according to AO guidelines using the Implant "1/3 tubular plate"	Procedure: ORIF non-locking
Active ankle plate	Active Comparator	Actual care using the new implant using the Implant "Active ankle plate"	Procedure: ORIF locking

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ORIF non-locking	Procedure	Open reduction and internal fixation using 1/3 tubular plate	1/3 tubular plate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ankle function	Clinical objective ankle function assessed by Olerud and Molander ankle score (OMAS)	12 month

Secondary Outcomes

Measure	Description	Time Frame
Ankle function	Clinical objective ankle function assessed by Foot and Ankle outcome score (FAOS)	12 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age between 18 and 65 years
Fracture of the distal fibula (AO 44 B1.1, B1.2, B1.3)
Written informed consent

Exclusion Criteria:

Pregnancy
mental disorders
comprehensive legal support.
pathological and/or osteoporotic fracture
open fracture

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33563235	Derived	Zyskowski M, Wurm M, Greve F, Pesch S, von Matthey F, Pfluger P, Cronlein M, Biberthaler P, Kirchhoff C. Is early full weight bearing safe following locking plate ORIF of distal fibula fractures? BMC Musculoskelet Disord. 2021 Feb 9;22(1):159. doi: 10.1186/s12891-021-04009-x.

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries
D016512	Ankle Injuries
D007869	Leg Injuries