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

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

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.

Study Overview

• Status: Completed
• Conditions: Lateral Malleolus Fractures
• Intervention / Treatment: Other: Splint 3 weeks; Other: Cast 3 weeks; Other: Cast 6 weeks

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.

• Study Type: Interventional
• Enrollment (Actual): 247
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Oulu, Finland, 90100
    • OYS, kirurgian klinkka, Oulu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Splint 3 weeks; Removable ankle brace/splint	Other: 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.
ACTIVE_COMPARATOR: Cast 3 weeks; Below-the-knee cast (glass fiber)	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.
ACTIVE_COMPARATOR: Cast 6 weeks; Below-the-knee cast (glass fiber)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Olerud-Molander score	Ankle functional outcome measure	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fracture healing		1 year
FAOS	Foot and Ankle Outcome Score	1 year
VAS	Visual Analogue Scale pain and function	1 year
RAND 36 Health item survey	Quality of life measurement	1 year

Collaborators and Investigators

• Sponsor: University of Oulu
• Collaborators: Tampere University Hospital

Publications and helpful links

General Publications

• 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. Erratum In: BMJ. 2019 Feb 19;364:l457.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ACTUAL): June 1, 2016
• Study Completion (ACTUAL): December 1, 2017

Study Registration Dates

• First Submitted: December 21, 2012
• First Submitted That Met QC Criteria: December 31, 2012
• First Posted (ESTIMATE): January 1, 2013

Study Record Updates

• Last Update Posted (ACTUAL): October 18, 2018
• Last Update Submitted That Met QC Criteria: October 16, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: fibula; ER-stress-test negative; unimalleolar; Weber-B fractures
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Ankle Fractures; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Cysteine Proteinase Inhibitors; Calpastatin
• Other Study ID Numbers: OYSrctAnkle5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO