Outcome Following Semitubular Plate vs. Polyaxial Locking Plates

NCT04370561 | Completed

• 1 other identifier: ActiveAnkle_0815
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Ankle function

  Clinical objective ankle function assessed by Olerud and Molander ankle score (OMAS)

  12 month

Secondary Outcomes (1)

• Ankle function

  12 month

Study Arms (2)

1/3 tubular plate

ACTIVE COMPARATOR

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

Procedure: ORIF non-locking

Active ankle plate

ACTIVE COMPARATOR

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

Procedure: ORIF locking

Interventions

ORIF non-locking PROCEDURE

Open reduction and internal fixation using 1/3 tubular plate

1/3 tubular plate

ORIF locking PROCEDURE

Open reduction and internal fixation using active ankle polyaxial locking plate

Active ankle plate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 65 years
• Fracture of the distal fibula (AO 44 B1.1, B1.2, B1.3)
• Written informed consent

You may not qualify if:

• Pregnancy
• mental disorders
• comprehensive legal support.
• pathological and/or osteoporotic fracture
• open fracture

Sponsors & Collaborators

• Technical University of Munich: lead

Related Publications (1)

• 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.

  PMID: 33563235 DERIVED

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Study Officials

• Chlodwig Kirchhoff, MD

  Klinik für Unfallchirurgie, Klinikum rechts der Isar, TU München

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: May 1, 2020
• Study Start: January 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2019
• Last Updated: May 5, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share