NCT06559111

Cast or Functional Ankle Orthosis After Ankle Fracture Surgery

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Töölö Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ankle Fracture
• Postoperative Treatment

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	6-week casting	Participants in the casting group had a cast for 6 weeks after the surgery.

Timeline

• Start date: 2005-12-01
• Primary completion: 2010-06-16
• Completion: 2012-03-16
• First posted: 2024-08-19
• Last updated: 2025-04-11