Skip to main content
OpenTrials
Completed

NCT Number: NCT05412693

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Østfold Hospital Trust, Sarpsborg, Østfold fylke, Norway

Loading trial locations.

About this study

Evidence suggests that Weber B ankle fractures should be treated nonoperatively if the ankle mortise is stable. Stability is maintained if the deltoid ligament is intact, also known as a Weber B/SER2 injury. Functional orthosis treatment is advised for these injuries. Recently, authors have demonstrated that the fractured ankle can be functionally stable even with a partial deltoid ligament injury. Our interpretation of a partial deltoid ligament injury is when weightbearing radiographs indicate stability (no increase in medial clear space), while concomitant gravity stress radiographs indicate instability (due to increase in medial clear space). It is suggested that this is referred to as a Weber B/SER4a injury. Although now considered for nonoperative treatment, partially unstable/SER4a injuries were traditionally treated operatively. Today, the superiority of one method of nonoperative treatment over another for partially unstable/SER4a injuries remains unclear. Some authors advocate cast immobilization while others have shown good outcomes after inconsistently using different orthoses and cast devices. The argument for cast immobilization appears to be a fear of posttraumatic osteoarthritis because of potential recurrent instability. As a result, cast immobilization of partially unstable/SER4a fractures is implemented in reference European guidelines, and thus must be considered the reference treatment. To our knowledge, no study has documented increased prevalence of osteoarthritis associated with functional treatment of partially unstable/SER4a fractures. The use of cast immobilization remains a precautionary principle, but the choice is not so clear cut because cast immobilization comes with an increased risk of joint stiffness and thromboembolic complications. Long-term radiographic and patient-reported outcome data evaluating possible non-inferiority of functional orthosis treatment compared to cast immobilization will assist in guiding future treatment strategies of these common fractures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 18-80 years of age
  • With pre-injury walking ability without aids.

Exclusion criteria

  • 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).

Treatment and study plan

Functional orthosis

Device

See arm descriptions

Cast immobilization

Device

See arm descriptions

Primary outcomes

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

    Time frame: 2 years

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

Secondary outcomes

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

    Time frame: 2 years

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

  2. Numeric rating scale of of patient satisfaction with treatment protocol

    Time frame: 6 weeks

    A 0-10 rating scale for perceived satisfaction with orthosis or cast

  3. Tibiotalar congruity comparing injured and uninjured ankle at 2 years

    Time frame: 2 years

    Measurement of ankle medial clear space from weightbearing and gravity stress ankle radiographs

  4. Registrations of complications/adverse events

    Time frame: 2 years

    Registration of possible loss of congruence, delayed union, non-union, thromboembolic events

  5. Change from 6 weeks ankle range of motion at 2 years

    Time frame: 6 weeks, 2 years

    Measurement using a goniometer (ad modum Lindsjø)

Sponsors and collaborators

Lead sponsor

Ostfold Hospital Trust

Other

Collaborators

  • Alesund Hospital
  • Sykehuset Innlandet HF

Registry information

Official study title

Six Weeks Functional Orthosis Versus Cast Immobilization for Partially Unstable Weber B/SER4a Ankle Fractures - a Multicenter Randomized Non-inferiority Trial

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 9, 2022
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.