Outcome Following Semitubular Plate vs. Polyaxial Locking Plates

Technical University of Munich

Status: Completed

Conditions: Ankle Fractures

Treatments: Procedure: ORIF non-locking; Procedure: ORIF locking

Study type: Interventional

Funder types: Other

Identifiers

NCT04370561

ActiveAnkle_0815

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

1/3 tubular plate

Active Comparator group

Description:

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

Treatment:

Procedure: ORIF non-locking

Active ankle plate

Active Comparator group

Description:

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

Treatment:

Procedure: ORIF locking