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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

247 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lateral Malleolus Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Splint 3 weeks

Removable ankle brace/splint

Group Type ACTIVE_COMPARATOR

Splint 3 weeks

Intervention Type OTHER

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 weeks

Below-the-knee cast (glass fiber)

Group Type ACTIVE_COMPARATOR

Cast 3 weeks

Intervention Type OTHER

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 weeks

Below-the-knee cast (glass fiber)

Group Type ACTIVE_COMPARATOR

Cast 6 weeks

Intervention Type OTHER

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.

Interventions

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Splint 3 weeks

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.

Intervention Type OTHER

Cast 3 weeks

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.

Intervention Type OTHER

Cast 6 weeks

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes