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

Lateral Malleolus Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01758835
• Other study ID #: OYSrctAnkle5
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: December 2017

Study information

• Verified date: October 2018
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: December 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone
• Lateral Malleolus Fractures

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Finland	OYS, kirurgian klinkka, Oulu	Oulu

Sponsors (2)

Lead Sponsor	Collaborator
University of Oulu	Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Olerud-Molander score	Ankle functional outcome measure	1 year
Secondary	FAOS	Foot and Ankle Outcome Score	1 year
Secondary	VAS	Visual Analogue Scale pain and function	1 year
Secondary	RAND 36 Health item survey	Quality of life measurement	1 year
Secondary	Fracture healing		1 year