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Completed

NCT Number: NCT06559111

Cast or Functional Ankle Orthosis After Ankle Fracture Surgery

The goal of this randomized clinical trial was to compare the effect of 6-week casting versus 2-week casting followed by 4-week ankle bracing in adult patients with surgically treated ankle fractures.

The primary outcome measures used were the functional results 3 months after surgery evaluated using two functional outcome measures (Olerud and Molander score and Kaikkonen score) and the patient return to work.

In the casting group, the traditional plaster was changed to a fiberglass one at 2 weeks and the cast treatment continued until 6 weeks. In the functional treatment group, the traditional plaster cast was changed to an reusable semi-rigid plastic orthosis (Aircast) at 2 weeks after surgery and its use was continued as an ankle support for up to 6 weeks. Follow-ups including subjective and objective evaluations were at 2, 6, 12 and 52 weeks and at 2 years postoperatively.

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Key information

Conditions

Ankle Fracture Ankle Fractures Ankle Injuries Fractures, Bone Leg Injuries Postoperative Treatment Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Weber A or B type ankle fracture
  • uni-, bi- or trimalleolar injury and/or fibular displacement of >2 mm in any plane on the radiographs

Exclusion criteria

  • Weber C injury necessitating syndesmotic fixation
  • Pilon injury
  • Inadequate co-operation
  • Other severe concomitant injuries

Treatment and study plan

2-week casting followed by 4-week bracing

Device

Participants in the bracing group had a cast for 2 weeks after the surgery followed by ankle brace for 4 weeks.

6-week casting

Device

Participants in the casting group had a cast for 6 weeks after the surgery.

Primary outcomes

  1. Olerud-Molander score

    Time frame: 3 months and 24 months

    Patient-reported outcome measure, 0-100 points, higher points indicating better result.

Secondary outcomes

  1. Olerud-Molander score

    Time frame: 6 weeks and 12 months

    Patient-reported outcome measure, 0-100 points, higher points indicating better result.

  2. Kaikkonen score

    Time frame: 6 weeks, 3, 12, and 24 months

    Patient-reported outcome measure, 0-100 points, higher points indicating better result.

  3. Visual Analog Scale for Pain

    Time frame: 6 weeks, 3, 12, and 24 months

    0-10, higher score indicating more pain.

  4. Swelling of the ankle

    Time frame: 6 weeks, 3, 12, and 24 months

    Circumference in millimetres compared to unaffected side

  5. Atrophy of the calf muscles

    Time frame: 6 weeks, 3, 12, and 24 months

    Circumference in millimetres compared to unaffected side

  6. Ankle active dorsiflexion

    Time frame: 6 weeks, 3, 12, and 24 months

    Degrees compared to unaffected side

  7. Ankle active plantarflexion

    Time frame: 6 weeks, 3, 12, and 24 months

    Degrees compared to unaffected side

  8. Return-to-work

    Time frame: Within 24 months

    Days after the injury

  9. Subjective symptoms and return to activities

    Time frame: 2 and 6 weeks; 3, 12, and 24 months

    The patients were questioned about the subjective symptoms (pain, swelling, stiffness and giving way) and about the compliance of using the cast or brace. In addition the patients were asked about the length of their inability to work and participate in the daily activities and/or sports at the preinjury level.

Other outcomes

  1. Complications

    Time frame: 2 and 6 weeks; 3, 12, and 24 months

    Infection, loss of reduction, implant loosening, deep vein thrombosis

Sponsors and collaborators

Lead sponsor

Töölö Hospital

Other

Collaborators

  • Tampere University Hospital

Registry information

Official study title

Postoperative Care After Operatively Treated Ankle Fractures With Cast or Functional Ankle Orthosis. A 2-year, Prospective, Randomized Clinical Trial

Important dates

Study start
2005
Primary completion
2010
Study completion
2012
First posted
Aug 19, 2024
Registry last updated
Apr 11, 2025

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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