Outcome Following Semitubular Plate vs. Polyaxial Locking Plates

NCT ID: NCT04370561

Last Updated: 2020-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2019-01-01

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.

Conditions

Ankle Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1/3 tubular plate

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

Group Type: ACTIVE_COMPARATOR

ORIF non-locking

Intervention Type: PROCEDURE

Open reduction and internal fixation using 1/3 tubular plate

Active ankle plate

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

Group Type: ACTIVE_COMPARATOR

ORIF locking

Intervention Type: PROCEDURE

Open reduction and internal fixation using active ankle polyaxial locking plate

Interventions

ORIF non-locking

Open reduction and internal fixation using 1/3 tubular plate

Intervention Type: PROCEDURE

ORIF locking

Open reduction and internal fixation using active ankle polyaxial locking plate

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Dr. Chlodwig Kirchhoff

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chlodwig Kirchhoff, MD

Role: PRINCIPAL_INVESTIGATOR

Klinik für Unfallchirurgie, Klinikum rechts der Isar, TU München

References

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.

Reference Type: DERIVED

PMID: 33563235 (View on PubMed)

Other Identifiers

ActiveAnkle_0815

Identifier Type: -

Identifier Source: org_study_id