NCT03377205

Brief Summary

The purpose of this study is to make a survey of functional outcome, radiological outcome and complication rate after intramedullary nailing (IMN) and plate fixation of Weber B ankle fractures in elderly patients, and contribute in choosing the best surgical method for these ankle fractures.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2017

Completed
9 months until next milestone

First Posted

Study publicly available on registry

December 19, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

5 years

First QC Date

March 21, 2017

Last Update Submit

July 11, 2023

Conditions

Ankle Fractures

Outcome Measures

Primary Outcomes (1)

  • American Orthopaedic Foot and Ankle Society (AOFAS) score

    Functional outcome as assessed by AOFAS score (0-100)

    5 years

Secondary Outcomes (11)

  • Manchester-Oxford Foot questionnaire (MOxFQ)

    5 years

  • Olerud and Molander Score (OMS)

    5 years

  • EuroQol-5d (Eq-5d)

    5 years

  • Visual analogue scale (VAS)

    5 years

  • Fracture reduction as assessed by CT scans

    3 months

  • +6 more secondary outcomes

Study Arms (2)

Plate

ACTIVE COMPARATOR

Compression screws and neutralization plate.

Device: Compression screws and neutralization plate

Intramedullary nail

EXPERIMENTAL

Acumed Fibular Rod System

Device: Acumed Fibular Rod System

Interventions

Compression screws and neutralization plateDEVICE

Open reduction and internal fixation with screws and plate

Plate
Acumed Fibular Rod SystemDEVICE

intramedullary nailing of fibula

Intramedullary nail

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute unstable Weber B fracture (unimalleolar, bimalleolar or trimalleolar fractures).
  • Operable with both methods of surgery within 3 weeks after injury.
  • Men and women ≥ 60 yoa.

You may not qualify if:

  • Prior injury or pathology with reduced ankle function.
  • Other acute foot/ankle/leg injury that will affect ankle function.
  • Fracture of the posterior malleolus that need fixation.
  • Injury / pathology that may affect rehabilitation.
  • Open fracture.
  • Inoperable patient.
  • Dementia (MMSE score ≤ 24 points), reduced competent to consent, not able to express himself/herself in Norwegian or English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0450, Norway

Location

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Study Officials

  • Elisabeth E Husebye, MD, PhD

    Oslo University Hospital

    STUDY CHAIR

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
Principal investigator

Study Record Dates

First Submitted

March 21, 2017

First Posted

December 19, 2017

Study Start

June 1, 2016

Primary Completion

June 1, 2021

Study Completion

January 1, 2026

Last Updated

July 13, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)