Functional Orthosis Versus Cast Immobilization for Partially Unstable Weber B Ankle Fractures

NCT05412693 | Active Not Recruiting

• 1 other identifier: 22/00257-3
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 3

Brief Summary

Stability dictates treatment choice for trans-syndesmotic fibula fractures. Optimal treatment for partially unstable fractures remains a topic of debate. The purpose of this study is to evaluate possible outcome non-inferior of functional orthosis treatment versus cast immobilization for these fractures.

Conditions

Ankle Fractures

Keywords

Weber B; SER4a

Outcome Measures

Primary Outcomes (1)

• Between-groups difference in Manchester-Oxford Foot and Ankle Questionnaire score at 2 years

  Scale 0-100, lower scores indicate less pain and symptoms.

  2 years

Secondary Outcomes (5)

• Between-groups difference in Olerud Molander Ankle Score at 2 years

  2 years

• Numeric rating scale of of patient satisfaction with treatment protocol

  6 weeks

• Tibiotalar congruity comparing injured and uninjured ankle at 2 years

  2 years

• Registrations of complications/adverse events

  2 years

• Change from 6 weeks ankle range of motion at 2 years

  6 weeks, 2 years

Study Arms (2)

Functional orthosis

EXPERIMENTAL

Use of a functional orthosis device (AirCast Air-Stirrup) for 6 weeks. Weightbearing as tolerated will be allowed in both groups immediately after application of the cast or orthosis.

Device: Functional orthosis

Cast immobilization

ACTIVE COMPARATOR

Use of a below-the-knee cast circular cast (3M scotch cast) for 6 weeks.

Device: Cast immobilization

Interventions

Functional orthosis DEVICE

See arm descriptions

Functional orthosis

Cast immobilization DEVICE

See arm descriptions

Cast immobilization

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients:
• With isolated Weber type B fractures that are deemed stable on weightbearing radiographs (MCS injured ankle - MCS uninjured ankle \< 1 mm).
• With concomitant gravity stress test evaluated as unstable (MCS injured ankle - MCS uninjured ankle \< 1 mm)
• Presenting to one of the participating hospitals, and that are available for stability evaluation within 14 days after injury.
• years of age
• With pre-injury walking ability without aids.

You may not qualify if:

• Patients:
• with fracture of the medial malleolus, pre-hospital closed fracture reduction, open fracture, fracture resulting from high-energy trauma or multi-trauma or pathologic fracture.
• with fracture of the posterior malleolus involving 25% or more of the joint surface or with a step of the intraarticular surface. (non-displaced fractures smaller than 25% can be included)
• with neuropathies and generalized joint disease such as Rheumatoid Arthritis.
• that are assumed not compliant (drug use, cognitive- and/or psychiatric disorders).
• with previous history of ipsilateral ankle fracture.
• with previous history of ipsilateral major ankle-/foot surgery.
• who live outside one of the participating hospitals catchment areas (not available for follow-up).

Sponsors & Collaborators

• Ostfold Hospital Trust: lead
• Alesund Hospital: collaborator
• Sykehuset Innlandet HF: collaborator

Study Sites (3)

Ålesund Hospital

Ålesund, Norway

Location

Sykehuset Innlandet, Gjøvik

Gjøvik, Norway

Location

Østfold Hospital Trust

Sarpsborg, Østfold fylke, 1714, Norway

Location

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking is not possible during the first 6 weeks of treatment due to the nature of the interventions. Investigators and outcome assessors will be masked for follow-up after 6 weeks.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Foot and Ankle Service

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: June 9, 2022
• Study Start: May 15, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (3)