Cast or Functional Ankle Orthosis After Ankle Fracture Surgery

NCT06559111 | Completed

• 1 other identifier: 06121917
• Study Type: interventional
• Target: 134
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Olerud-Molander score

  Patient-reported outcome measure, 0-100 points, higher points indicating better result.

  3 months and 24 months

Secondary Outcomes (9)

• Olerud-Molander score

  6 weeks and 12 months

• Kaikkonen score

  6 weeks, 3, 12, and 24 months

• Visual Analog Scale for Pain

  6 weeks, 3, 12, and 24 months

• Swelling of the ankle

  6 weeks, 3, 12, and 24 months

• Atrophy of the calf muscles

  6 weeks, 3, 12, and 24 months

Other Outcomes (1)

• Complications

  2 and 6 weeks; 3, 12, and 24 months

Study Arms (2)

Bracing group

EXPERIMENTAL

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

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

Casting group

ACTIVE COMPARATOR

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

Device: 6-week casting

Interventions

2-week casting followed by 4-week bracing DEVICE

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

Bracing group

6-week casting DEVICE

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

Casting group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Weber C injury necessitating syndesmotic fixation
• Pilon injury
• Inadequate co-operation
• Other severe concomitant injuries

Sponsors & Collaborators

• Töölö Hospital: lead
• Tampere University Hospital: collaborator

MeSH Terms

Conditions

Ankle Fractures

Interventions

Braces

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Teppo Järvinen, Prof

  Helsinki University Central Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 19, 2024
• Study Start: December 1, 2005
• Primary Completion: June 16, 2010
• Study Completion: March 16, 2012
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share