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Trial registered on ANZCTR

Registration number
Ethics application status
Not yet submitted
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Outcome and patients’ satisfaction after functional treatment of acute lateral ankle injuries at emergency departments versus family doctor offices
Scientific title
Outcome and patients’ satisfaction after functional treatment of acute lateral ankle injuries at emergency departments versus family doctor offices
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lateral ankle injuries 3134 0
Condition category
Condition code
Surgery 3297 3297 0 0
Other surgery

Study type
Description of intervention(s) / exposure
Early functional therapy, consisting of early antiphlogistic measures according the RICE procedure (Rest – Ice – Compression – Elevation), elastic support bandage, early return to full weight bearing after only a short period of immobilization and instruction for motion exercises to be begun at home after the acute phase. follow-up treatment at the Emergency Dep. The Study started May 2004 and ended December 2004. The physical therapy exercises were developed in collaboration with the Swiss Sports Institute (Eidgenössische Turn- und Sportschule in Magglingen, ESSM) and are designed to strengthen the peroneal muscles and improve neuromuscular control through proprioceptive training. It has to be done once a day for 30 min.
Intervention code [1] 2876 0
Treatment: Other
Comparator / control treatment
follow-up treatment in family doctor offices
Control group

Primary outcome [1] 4185 0
Patients satisfaction after early functional treatment and follow-up treatment by a Questionnaire for evaluation of subjective satisfaction regarding treatment management and outcome. On this protocol there was room left for additional information as the independent acquisition of stabilizing ortheses or the like.
Timepoint [1] 4185 0
1 and 8 weeks after first consultation
Secondary outcome [1] 7069 0
Clinical Outcome after early functional treatment. At final control the patients underwent a standardized physical examination for objective measure. (Swelling/Pain at Palpation). No stress radiography were performed at any time
Timepoint [1] 7069 0
8 weeks

Key inclusion criteria
Lateral ankle injuries
Minimum age
16 Years
Maximum age
71 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
non-obvious supination trauma, previous treatment by a general practitioner or in a different clinic, rupture of deltoid ligament, fractures, and refusal to participate on the part of the patient.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
use of stabilizing ortheses in both groups
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 964 0
State/province [1] 964 0

Funding & Sponsors
Funding source category [1] 3373 0
Name [1] 3373 0
University Hospital Bern
Address [1] 3373 0
University Hospital Bern
Emergency Department
Country [1] 3373 0
Primary sponsor type
University Hospital Bern
University Hospital Bern
Emergency Department
Secondary sponsor category [1] 3018 0
Name [1] 3018 0
Address [1] 3018 0
Country [1] 3018 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5398 0
Kantonalee Ethikkomission des Kantons Bern
Ethics committee address [1] 5398 0
Postfach 56
CH 30-10 Bern
Ethics committee country [1] 5398 0
Date submitted for ethics approval [1] 5398 0
Approval date [1] 5398 0
Ethics approval number [1] 5398 0

Brief summary
The basis of our study was the question whether patients, who chose the emergency room of the University Hospital for initial diagnosis, are satisfied with our initial therapy, and whether there is a difference in the level of satisfaction between the patients who receive follow-up care at our clinic or at their general practitioner’s office. Since our clinic does not prescribe ankle braces (Malleoloc or Aircast), the additional question arose as to whether the patients acquired such stabilizing ortheses themselves or were prescribed ankle braces by their general practitioner during the follow-up visit.
Trial website
Trial related presentations / publications
Presentation at the National Congress of Surgery 2005
Public notes

Principal investigator
Name 28582 0
Address 28582 0
Country 28582 0
Phone 28582 0
Fax 28582 0
Email 28582 0
Contact person for public queries
Name 11739 0
Patrik R. Schwab
Address 11739 0
Wasserwerkgasse 35
CH-3011 Bern
Country 11739 0
Phone 11739 0
0041 31 382 78 18
Fax 11739 0
Email 11739 0
Contact person for scientific queries
Name 2667 0
Aristomenis K. Exadaktylos
Address 2667 0
c/o University Hospital Bern
Emergency Department
CH-3010 Bern
Country 2667 0
Phone 2667 0
0041 31 632 21 11
Fax 2667 0
Email 2667 0

No information has been provided regarding IPD availability
Summary results
No Results