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Outcome Following Semitubular Plate vs. Polyaxial Locking Plates

Primary Purpose

Ankle Fractures

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

ORIF non-locking

ORIF locking

About this trial

This is an interventional treatment trial for Ankle Fractures

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

1/3 tubular plate

Active ankle plate

Arm Description

Standard care according to AO guidelines using the Implant "1/3 tubular plate"

Actual care using the new implant using the Implant "Active ankle plate"

Outcomes

Primary Outcome Measures

Ankle function

Clinical objective ankle function assessed by Olerud and Molander ankle score (OMAS)

Secondary Outcome Measures

Ankle function

Clinical objective ankle function assessed by Foot and Ankle outcome score (FAOS)

Full Information

NCT ID

NCT04370561

First Posted

April 20, 2020

Last Updated

May 1, 2020

Sponsor

Technical University of Munich

1. Study Identification

Unique Protocol Identification Number

NCT04370561

Brief Title

Outcome Following Semitubular Plate vs. Polyaxial Locking Plates

Official Title

a Prospective Randomized Study on the Outcome Following Osteosynthesis of Distal Fibula Fracture Using Semitubular Plate in AO Technique vs. Polyaxial Locking Plates

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

January 1, 2016 (Actual)

Primary Completion Date

January 1, 2018 (Actual)

Study Completion Date

January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Technical University of Munich

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ankle Fractures

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1/3 tubular plate

Arm Type

Active Comparator

Arm Description

Standard care according to AO guidelines using the Implant "1/3 tubular plate"

Arm Title

Active ankle plate

Arm Type

Active Comparator

Arm Description

Actual care using the new implant using the Implant "Active ankle plate"

Intervention Type

Procedure

Intervention Name(s)

ORIF non-locking

Intervention Description

Open reduction and internal fixation using 1/3 tubular plate

Intervention Type

Procedure

Intervention Name(s)

ORIF locking

Intervention Description

Open reduction and internal fixation using active ankle polyaxial locking plate

Primary Outcome Measure Information:

Title

Ankle function

Description

Clinical objective ankle function assessed by Olerud and Molander ankle score (OMAS)

Time Frame

12 month

Secondary Outcome Measure Information:

Title

Ankle function

Description

Clinical objective ankle function assessed by Foot and Ankle outcome score (FAOS)

Time Frame

12 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chlodwig Kirchhoff, MD

Organizational Affiliation

Klinik für Unfallchirurgie, Klinikum rechts der Isar, TU München

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33563235

Citation

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.

Results Reference

derived

Learn more about this trial

Outcome Following Semitubular Plate vs. Polyaxial Locking Plates

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