Clinical trial NCT01758835: PRCT-study of Different Non-operative Treatment Protocols of ER-stress Negative Weber-B Unimalleolar Ankle Fractures.
Official title: Evaluation of Different Non-operative Treatment Protocols of ER-stress Negative Weber-B Unimalleolar Ankle Fractures. A Prospective Randomized Multicenter Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Malleolus Fractures
Keywords: ER-stress-test negative
unimalleolar
fibula
Weber-B fractures
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Tampere University Hospital
First posted: 2013-01-01
Enrollment: 247
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Olerud-Molander score
timeFrame: 1 year
Secondary outcomes:
measure: FAOS
timeFrame: 1 year
measure: VAS
timeFrame: 1 year
measure: RAND 36 Health item survey
timeFrame: 1 year
measure: Fracture healing
timeFrame: 1 year
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: OYS, kirurgian klinkka, Oulu
Study officials:
affiliation: Oulu University Hospital
name: Harri J Pakarinen, MD, PhD
role: STUDY_DIRECTOR
affiliation: Oulu University Hospital
name: Tero HJ Kortekangas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kortekangas T, Haapasalo H, Flinkkila T, Ohtonen P, Nortunen S, Laine HJ, Jarvinen TL, Pakarinen H. Three week versus six week immobilisation for stable Weber B type ankle fractures: randomised, multicentre, non-inferiority clinical trial. BMJ. 2019 Jan 23;364:k5432. doi: 10.1136/bmj.k5432.