Cast or Functional Ankle Orthosis After Ankle Fracture Surgery

Not Applicable

Completed

• Conditions: Postoperative Treatment; Ankle Fracture
• Interventions: Device: 6-week casting; Device: 2-week casting followed by 4-week bracing

• Registration Number: NCT06559111
• Lead Sponsor: Töölö Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-01
• Primary Completion: 2010-06-16
• Study Completion: 2012-03-16
• Study First Submitted: 2024-08-14
• Study First Submitted QC: 2024-08-14
• Study First Posted: 2024-08-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Casting group	6-week casting	Participants in the casting group had a cast for 6 weeks after the surgery.
Bracing group	2-week casting followed by 4-week bracing	Participants in the bracing group had a cast for 2 weeks after the surgery followed by ankle brace for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Olerud-Molander score	3 months and 24 months	Patient-reported outcome measure, 0-100 points, higher points indicating better result.

Secondary Outcome Measures

Name	Time	Method
Olerud-Molander score	6 weeks and 12 months	Patient-reported outcome measure, 0-100 points, higher points indicating better result.
Kaikkonen score	6 weeks, 3, 12, and 24 months	Patient-reported outcome measure, 0-100 points, higher points indicating better result.
Visual Analog Scale for Pain	6 weeks, 3, 12, and 24 months	0-10, higher score indicating more pain.
Swelling of the ankle	6 weeks, 3, 12, and 24 months	Circumference in millimetres compared to unaffected side
Atrophy of the calf muscles	6 weeks, 3, 12, and 24 months	Circumference in millimetres compared to unaffected side
Ankle active dorsiflexion	6 weeks, 3, 12, and 24 months	Degrees compared to unaffected side
Ankle active plantarflexion	6 weeks, 3, 12, and 24 months	Degrees compared to unaffected side
Return-to-work	Within 24 months	Days after the injury
Subjective symptoms and return to activities	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.