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

University of Oulu247 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

247

Conditions

Lateral Malleolus Fractures

Interventions

Splint 3 weeksOTHER

A removable orthosis/splint. Dynacast/Ortho-Glass AS (BSN Medical). Splint is used for 3 weeks and no additional support is used after splint removal.

Cast 3 weeksOTHER

A standard short boot cast from proximal tibia to MTP I-V joint line. Cast is made from 3M Scotchcast. Cast is removed after 3 weeks and no additional support is used after cast removal.

Cast 6 weeksOTHER

standard short boot cast from proximal tibia to MTP I-V joint line. Cast is made from 3M Scotchcast. Cast is changed after 3 weeks and removed after 6 weeks. No additional support is used after cast removal.

Eligibility

Sex: ALLMin age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

OYS, kirurgian klinkka, Oulu

Oulu, Finland

Outcomes

Primary Outcomes

Olerud-Molander score

Ankle functional outcome measure

Time frame: 1 year

Secondary Outcomes

FAOS

Foot and Ankle Outcome Score

Time frame: 1 year

VAS

Visual Analogue Scale pain and function

Time frame: 1 year

RAND 36 Health item survey

Quality of life measurement

Time frame: 1 year

Fracture healing

Time frame: 1 year

Data from ClinicalTrials.gov

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