Cast or Functional Ankle Orthosis After Ankle Fracture Surgery

NCT ID: NCT06559111

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-01
• Study Completion Date: 2012-03-16

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.

Conditions

Ankle Fracture; Postoperative Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bracing group

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

Group Type: EXPERIMENTAL

2-week casting followed by 4-week bracing

Intervention Type: DEVICE

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

Casting group

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

Group Type: ACTIVE_COMPARATOR

6-week casting

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

6-week casting

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tampere University Hospital

OTHER

Sponsor Role: collaborator

Töölö Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lasse Rämö

Orthopaedic Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Teppo Järvinen, Prof

Role: STUDY_CHAIR

Helsinki University Central Hospital

Other Identifiers

06121917

Identifier Type: -

Identifier Source: org_study_id