Outcome Following Semitubular Plate vs. Polyaxial Locking Plates

Ankle Fractures Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04370561
• Other study ID #: ActiveAnkle_0815
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: January 1, 2019

Study information

• Verified date: May 2020
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fractures

Intervention

Procedure:
• ORIF non-locking
Open reduction and internal fixation using 1/3 tubular plate
• ORIF locking
Open reduction and internal fixation using active ankle polyaxial locking plate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ankle function	Clinical objective ankle function assessed by Olerud and Molander ankle score (OMAS)	12 month
Secondary	Ankle function	Clinical objective ankle function assessed by Foot and Ankle outcome score (FAOS)	12 month