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
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Fractures
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
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
No
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
No
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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