Outcome Following Semitubular Plate vs. Polyaxial Locking Plates

Not Applicable

Completed

• Conditions: Ankle Fractures
• Interventions: Procedure: ORIF non-locking; Procedure: ORIF locking

• Registration Number: NCT04370561
• Lead Sponsor: Technical University of Munich

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 available

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2018-01-01
• Study Completion: 2019-01-01
• Study First Submitted: 2020-04-20
• Study First Submitted QC: 2020-04-28
• Status Verified: 2020-05
• Study First Posted: 2020-05-01
• Last Update Submitted: 2020-05-01
• Last Update Posted: 2020-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1/3 tubular plate	ORIF non-locking	Standard care according to AO guidelines using the Implant "1/3 tubular plate"
Active ankle plate	ORIF locking	Actual care using the new implant using the Implant "Active ankle plate"

Primary Outcome Measures

Name	Time	Method
Ankle function	12 month	Clinical objective ankle function assessed by Olerud and Molander ankle score (OMAS)

Secondary Outcome Measures

Name	Time	Method
Ankle function	12 month	Clinical objective ankle function assessed by Foot and Ankle outcome score (FAOS)