Back to resultsPRCT-study of Different Non-operative Treatment Protocols of ER-stress Negative Weber-B Unimalleolar Ankle Fractures.
Primary Purpose
Lateral Malleolus Fractures
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Splint 3 weeks
Cast 3 weeks
Cast 6 weeks
Sponsored by
About this trial
This is an interventional treatment trial for Lateral Malleolus Fractures focused on measuring ER-stress-test negative, unimalleolar, fibula, Weber-B fractures
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
Sites / Locations
- OYS, kirurgian klinkka, Oulu
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Splint 3 weeks
Cast 3 weeks
Cast 6 weeks
Arm Description
Removable ankle brace/splint
Below-the-knee cast (glass fiber)
Below-the-knee cast (glass fiber)
Outcomes
Primary Outcome Measures
Olerud-Molander score
Ankle functional outcome measure
Secondary Outcome Measures
FAOS
Foot and Ankle Outcome Score
VAS
Visual Analogue Scale pain and function
RAND 36 Health item survey
Quality of life measurement
Fracture healing
Full Information
NCT ID
NCT01758835
First Posted
December 21, 2012
Last Updated
October 16, 2018
Sponsor
University of Oulu
Collaborators
Tampere University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01758835
Brief Title
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu
Collaborators
Tampere University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Malleolus Fractures
Keywords
ER-stress-test negative, unimalleolar, fibula, Weber-B fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
247 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Splint 3 weeks
Arm Type
Active Comparator
Arm Description
Removable ankle brace/splint
Arm Title
Cast 3 weeks
Arm Type
Active Comparator
Arm Description
Below-the-knee cast (glass fiber)
Arm Title
Cast 6 weeks
Arm Type
Active Comparator
Arm Description
Below-the-knee cast (glass fiber)
Intervention Type
Other
Intervention Name(s)
Splint 3 weeks
Intervention Description
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
Intervention Name(s)
Cast 3 weeks
Intervention Description
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
Intervention Name(s)
Cast 6 weeks
Intervention Description
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 Outcome Measure Information:
Title
Olerud-Molander score
Description
Ankle functional outcome measure
Time Frame
1 year
Secondary Outcome Measure Information:
Title
FAOS
Description
Foot and Ankle Outcome Score
Time Frame
1 year
Title
VAS
Description
Visual Analogue Scale pain and function
Time Frame
1 year
Title
RAND 36 Health item survey
Description
Quality of life measurement
Time Frame
1 year
Title
Fracture healing
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harri J Pakarinen, MD, PhD
Organizational Affiliation
Oulu University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tero HJ Kortekangas, MD
Organizational Affiliation
Oulu University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
OYS, kirurgian klinkka, Oulu
City
Oulu
ZIP/Postal Code
90100
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30674451
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. Erratum In: BMJ. 2019 Feb 19;364:l457.
Results Reference
derived
Learn more about this trial
PRCT-study of Different Non-operative Treatment Protocols of ER-stress Negative Weber-B Unimalleolar Ankle Fractures.
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