Cast or Functional Ankle Orthosis After Ankle Fracture Surgery

Töölö Hospital

Status: Completed

Conditions: Postoperative Treatment; Ankle Fracture

Treatments: Device: 6-week casting; Device: 2-week casting followed by 4-week bracing

Study type: Interventional

Funder types: Other

Identifiers

NCT06559111

06121917

Details and patient eligibility

About

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.

Enrollment: 134 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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134 participants in 2 patient groups

Bracing group

Experimental group

Description:

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

Treatment:

Device: 2-week casting followed by 4-week bracing

Casting group

Active Comparator group

Description:

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

Treatment:

Device: 6-week casting