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NCT Number: NCT05765929

Use of Weightbearing Radiographs to Determine Treatment of bi- and Trimalleolar Ankle Fractures

The aim of this study is to evaluate the outcomes after non-operative treatment of weightbearing stable bi-and trimalleolar ankle fractures.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • -With bi- and trimalleolar ankle fractures with less than 7 mm medial clear space on non-weightbearing radiographs that are deemed stable by weightbearing radiographs.
  • With type B medial malleolus fractures between the tip and the plafond and type C medial malleolus fractures at the level of the plafond (Herscovici classification). (6)
  • With fractures in the distal 1/3 of fibula (not-Maisonneuve)
  • Enabling stability evaluation within 14 days after injury
  • 18-75 years of age
  • with pre-injury walking ability without aids

Exclusion criteria

  • - With primary unstable ankle fractures, > 7mm medial clear space on primary radiographs
  • With fracture reduction prior to initial radiographic evaluation, open fracture, fractures resulting from high-energy trauma or multi trauma and pathological fracture
  • With type A medial malleolus avulsion fractures < 5mm (at the tip of the malleolus), that are not suitable for surgical intervention.
  • With Herscovici type D fractures, involving Lauge-Hansen SA2 fractures (supracollicular fracture - vertical, oblique or transverse direction of the plafond)
  • With displaced posterior malleolus fractures that needs fixation in the judgement of the attending surgeon
  • With neuropathies and symptomatic joint diseases such as Rheumatoid Arthritis
  • That are assumed not compliant (such as drug abuse, cognitive- and/or psychiatric disorders)
  • With previous history ipsilateral ankle fracture
  • With previous history ipsilateral major ankle-/foot surgery
  • Who live outside the hospital catchment areas not available to follow up
  • With insufficient Norwegian or English language skills
  • Non-compliant

Treatment and study plan

Non-operative treatment

Other

Patients will be treated with a walker-orthosis for 6 weeks. Weightbearing as tolerated

Primary outcomes

  1. Olerud Molander Score (OMAS) to measure a change over time

    Time frame: 6 week, 12 weeks, 1year, 2 years

    Condition specific, patient reported measure of ankle-fracture symptoms

Secondary outcomes

  1. Manchester-Oxford Foot Questionnaire (MOxFQ)

    Time frame: 6 week, 12 weeks, 1year, 2 years

    Patients reported outcomes

  2. Range of Motion measured by a goniometer (ad modum Lindsjo)

    Time frame: 6 week, 12 weeks, 1year, 2 years

    dorsiflexion and plantarflexion

  3. Numeric Rating Scale (NRS)

    Time frame: 6 week, 12 weeks, 1year, 2 years

    Ankle pain in rest, at night and in daily activities, a 11-point numeric scale ranging from 0-10

  4. Euroqol questionnaire (EQ- 5D)

    Time frame: 6 week, 12 weeks, 1year, 2 years

    Health related quality of life

  5. Registrations of complications/adverse events

    Time frame: 0-2 years

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

  6. Posttraumatic osteoarthritis (OA)

    Time frame: 2 years and 5 years

    CT-scan (Kellgren-Lawrence classification)

Study contacts

Contact information is provided by the study sponsor or research team.

Marius Molund, PhD

CONTACT

[email protected]

0047 90093988

Silje Karlsen

CONTACT

[email protected]

0047 90761773

Sponsors and collaborators

Lead sponsor

Ostfold Hospital Trust

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2032
First posted
Mar 13, 2023
Registry last updated
Aug 8, 2023

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.

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