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The treatment of stable ankle fractures: Brace versus Cast immobilization

The treatment of stable ankle fractures: Brace versus Cast immobilization - GIBRA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39792
Enrollment
100
Registered
2012-11-28
Start date
2013-01-14
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ankle fracture Fibula fracture Stable ankle fracture

Interventions

At 1 week post fracture the patient will return to the clinic. If he/she is willing to participate in the trial the randomization will take place. Group 1 consists of patients treated with cast immob

Sponsors

Medisch Centrum Haaglanden
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with a stable ankle fracture (type Weber B and less than 2 mm dislocation), between the age of 18 and 65 years old

Exclusion criteria

Exclusion criteria: Multiple fractures Patients with an mental handicap Patients not living in the right region, follow up takes place in a different medical centre. Patients who do not speak Dutch fluently

Design outcomes

Primary

MeasureTime frame
The function of the ankle will be assessed by using a questionnaire, the Olerud & Molander Ankle Score, which the patient will be asked to fill in9. This scoring system is specifically designed to demonstrate the function of the ankle after an ankle injury, mainly for short term evaluation. The scoring system is well-recognized, is validated and patient-friendly9. Nine questions combine the aspects of pain, swelling, stiffness and ability to perform certain activities to one overall score of 0-100 points, the higher the score, the better the function of the ankle. Primary outcome is the Olerud & Molander Score at 6 weeks.

Secondary

MeasureTime frame
The level of pain will be assessed using a 10-point Visual Analogue Scale (VAS), in which 0 implies no pain and 10 implies the worst possible pain. Patient comfort with regard to the type of immobilization (cast or brace) will also be assessed using a 10-point Visual Analogue Scale (VAS), in which 0 implies not comfortable at all and 10 implies very comfortable. By measuring the maximum active dorsiflexion and maximum active plantar flexion with a goniometer the Range of Motion will be assessed. The degree of fracture dislocation will be determined using radiographs. De American Academy of Orthopaedic Surgeons Foot and Ankle score (AAOS-score) will be completed by the patient as from 26 weeks post fracture, this score reflects the function of the ankle in the long term10. This scoring system combines 25 items for pain, function, stiffness, swelling and giving way, which generates a single score of 0-100 points, the higher the score, the better the function of the ankle. Euroqol-5D (EQ-5D) is a validated questionnaire for health-related quality of life. The presence of osteoarthritis at 1 year post fracture will be determined using radiographs which will be staged according to the Ankle Osteoarthritis Scale13. The time to return to work will be documented for all patients.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)