PRCT-study of Different Non-operative Treatment Protocols of ER-stress Negative Weber-B Unimalleolar Ankle Fractures.

University of Oulu

Status: Completed

Conditions: Lateral Malleolus Fractures

Treatments: Other: Cast 6 weeks; Other: Cast 3 weeks; Other: Splint 3 weeks

Study type: Interventional

Funder types: Other

Identifiers

NCT01758835

OYSrctAnkle5

Details and patient eligibility

About

PRCT multicenter study to evaluate non-operative treatment protocols for treating ER-stress negative unimalleolar Weber-B type fibular fractures. Groups are: 1. 3 weeks in a removable splint 2. 3 weeks in a cast and 3. 6 weeks in a cast. Follow-up visits at 3, 6 and 12 weeks and after 1 and 2 years after injury. In each time X-rays laterally and mortise projections. Ankle functional outcome questionnaires: Olerud-Molander score, FAOS RAND-36 and VAS in follow up-visits 6 and 12 weeks and 1 and 2 year.

Full description

Prospective randomized controlled multicenter study to evaluate non-operative treatment protocols for treating ER-stress negative unimalleolar Weber-B type fibular fractures. Groups are: 1. 3 weeks in a removable splint 2. 3 weeks in a cast and 3. 6 weeks in a cast. Follow-up visits at 3, 6 and 12 weeks and after 1 and 2 years after injury. In each time X-rays laterally and mortise projections. Ankle functional outcome questionnaires: Olerud-Molander score, FAOS RAND-36 and VAS in follow up-visits 6 and 12 weeks and 1 and 2 year.

Enrollment: 247 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Stable Weber-B type fibula fracture
• ER-stress negative
• 16 or over years old
• Willingness to participate on study proved by a signature and date
• Walking without aid before accident
• Treatment started within 7 days from injury

Exclusion criteria

• Prior ankle fracture or significant fracture in the area of ankle or leg
• Bilateral ankle fracture
• Pathological fracture
• Diabetes mellitus or an other significant periferial neuropathy
• municipality of Residence in some else catchment area than Oulu university hospital or Tampere university hospital
• Patient's understanding or co-operation inadequate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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247 participants in 3 patient groups

Splint 3 weeks

Active Comparator group

Description:

Removable ankle brace/splint

Treatment:

Other: Splint 3 weeks

Cast 3 weeks

Active Comparator group

Description:

Below-the-knee cast (glass fiber)

Treatment:

Other: Cast 3 weeks

Cast 6 weeks

Active Comparator group

Description:

Below-the-knee cast (glass fiber)

Treatment:

Other: Cast 6 weeks