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Cast or Functional Ankle Orthosis After Ankle Fracture Surgery

NCT06559111 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2025-04-11

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Tampere University Hospital

    collaborator OTHER

  • Töölö Hospital

    lead OTHER

Principal Investigators

  • Teppo Järvinen, Prof · Helsinki University Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-01
Primary Completion
2010-06-16
Completion
2012-03-16

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06559111 on ClinicalTrials.gov