NCT03831009

Brief Summary

The investigators will conduct a prospective cohort study on the use of weight-bearing radiographs to evaluate stability in ankles with isolated, trans-syndesmotic (Weber type B) fibular fractures. Stable fractures will be treated conservatively using a functional brace, unstable fractures will undergo surgical fixation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 19, 2023

Status Verified

June 1, 2022

Enrollment Period

3.5 years

First QC Date

February 4, 2019

Last Update Submit

January 18, 2023

Conditions

Lateral Malleolus FracturesAnkle Fractures

Outcome Measures

Primary Outcomes (1)

  • The Manchester-Oxford Foot Questionnaire (MOxFQ)

    Ankle/foot specific patient-reported outcome measure

    24 months

Secondary Outcomes (8)

  • Olerud-Molander Ankle Score (OMAS)

    24 months

  • AOFAS ankle-hindfoot

    24 months

  • VAS/NRS of pain

    24 months

  • Eq-5d

    24 months

  • Fracture healing

    24 months

  • +3 more secondary outcomes

Study Arms (4)

Weight-bearing stable/Gravity stable

ACTIVE COMPARATOR

Ankles that are considered stable using weight-bearing radiographs AND gravity stress test will be assigned to conservative treatment

Other: Conservative treatment

Weight-bearing stable/Gravity unstable

ACTIVE COMPARATOR

Ankles that are considered stable using weight-bearing radiographs but unstable using gravity stress test will be assigned to conservative treatment

Other: Conservative treatment

Weight-bearing unstable/Gravity unstable

ACTIVE COMPARATOR

Ankles that are considered unstable using weight-bearing radiographs AND gravity stress test will be assigned to open reduction internal fixation (ORIF)

Procedure: Open reduction internal fixation (ORIF)

Weight-bearing unstable/Gravity stable

ACTIVE COMPARATOR

Ankles that are considered unstable using weight-bearing radiographs but stable using gravity stress test will be assigned to open reduction internal fixation (ORIF)

Procedure: Open reduction internal fixation (ORIF)

Interventions

Open reduction internal fixation (ORIF)PROCEDURE

Open fracture reduction followed by internal fixation using a plate and screws. The goal is an osteosynthesis that allow for early range-of-motion exercises, but weightbearing is usually not tolerated until 6 weeks postoperatively.

Weight-bearing unstable/Gravity stableWeight-bearing unstable/Gravity unstable
Conservative treatmentOTHER

Conservative treatment involves ankle protection with a functional brace (AirCast) for 6 weeks. Participants will be instructed to bear weight as tolerated and to actively do standardized range-of-motion exercises.

Weight-bearing stable/Gravity stableWeight-bearing stable/Gravity unstable

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Isolated Weber type B fractures without radiological signs of medial clear space widening on initial radiographs. Patients must be 18-80 years of age. Before the injury patients should be mobilized without walking aids. They should be compliant with good communication skills in the Norwegian or English languages. Patients must live in Østfold or nearby areas so they are able to meet to follow-up consultations.

You may not qualify if:

  • Patients presenting with any of the following will be excluded from the study: Fracture of the medial malleolus. Information about prehospital fracture closed reduction. Open fracture. Fracture resulting from high-energy trauma or multi-trauma. Pathologic fracture. Diabetes Mellitus type 1 and 2. Neuropathies. Cognitive disorders. Previous history of ankle fracture. Previous history of ankle-/foot surgery. Generalized joint disease such as RA. Patients with insufficient Norwegian or English language proficiency or lack of communication skills.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Østfold Hospital Trust

Sarpsborg, Østfold fylke, 1714, Norway

Location

Related Links

MeSH Terms

Conditions

Ankle Fractures

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Marius Molund

    Ostfold Hospital Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Two-arm parallel assignment. Based on stability evaluation using weight-bearing adiographs one group recieves surgery, one group recieves non-surgical treatment.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2019

First Posted

February 5, 2019

Study Start

January 1, 2019

Primary Completion

June 30, 2022

Study Completion

December 31, 2022

Last Updated

January 19, 2023

Record last verified: 2022-06

Locations

NO(1)