Overview

This trial is active, not recruiting.

Condition lateral malleolus fractures
Treatments splint 3 weeks, cast 3 weeks, cast 6 weeks
Sponsor University of Oulu
Collaborator Tampere University Hospital
Start date October 2012
End date June 2016
Trial size 246 participants
Trial identifier NCT01758835, OYSrctAnkle5

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Removable ankle brace/splint
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)
Below-the-knee cast (glass fiber)
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)
Below-the-knee cast (glass fiber)
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.

Primary Outcomes

Measure
Olerud-Molander score
time frame: 1 year

Secondary Outcomes

Measure
FAOS
time frame: 1 year
VAS
time frame: 1 year
RAND 36 Health item survey
time frame: 1 year
Fracture healing
time frame: 1 year

Eligibility Criteria

Male or female participants at least 16 years old.

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

Additional Information

Official title Evaluation of Different Non-operative Treatment Protocols of ER-stress Negative Weber-B Unimalleolar Ankle Fractures. A Prospective Randomized Multicenter Trial.
Principal investigator Tero HJ Kortekangas, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Oulu.