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Completed

NCT Number: NCT01758835

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

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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Key information

Conditions

Lateral Malleolus Fractures Ankle Fractures Ankle Injuries Fractures, Bone Leg Injuries Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OYS, kirurgian klinkka, Oulu

Oulu, 90100, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Splint 3 weeks

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

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

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.

Primary outcomes

  1. Olerud-Molander score

    Time frame: 1 year

    Ankle functional outcome measure

Secondary outcomes

  1. FAOS

    Time frame: 1 year

    Foot and Ankle Outcome Score

  2. VAS

    Time frame: 1 year

    Visual Analogue Scale pain and function

  3. RAND 36 Health item survey

    Time frame: 1 year

    Quality of life measurement

  4. Fracture healing

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Collaborators

  • Tampere University Hospital

Registry information

Official study title

Evaluation of Different Non-operative Treatment Protocols of ER-stress Negative Weber-B Unimalleolar Ankle Fractures. A Prospective Randomized Multicenter Trial.

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Jan 1, 2013
Registry last updated
Oct 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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