Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000246381
Ethics application status
Not yet submitted
Date submitted
10/05/2008
Date registered
14/05/2008
Date last updated
14/05/2008
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

Intervention/exposure
Study type
Interventional
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
Active

Outcomes
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

Eligibility
Key inclusion criteria
Lateral ankle injuries
Minimum age
16 Years
Maximum age
71 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Parallel
Other design features
use of stabilizing ortheses in both groups
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/05/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 964 0
Switzerland
State/province [1] 964 0
Bern

Funding & Sponsors
Funding source category [1] 3373 0
Hospital
Name [1] 3373 0
University Hospital Bern
Country [1] 3373 0
Switzerland
Primary sponsor type
Hospital
Name
University Hospital Bern
Address
University Hospital Bern
Emergency Department
Postfach
Country
Switzerland
Secondary sponsor category [1] 3018 0
None
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
Switzerland
Date submitted for ethics approval [1] 5398 0
01/01/2004
Approval date [1] 5398 0
Ethics approval number [1] 5398 0

Summary
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

Contacts
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
Switzerland
Phone 11739 0
0041 31 382 78 18
Fax 11739 0
Email 11739 0
patrik.schwab@gmx.ch
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
Switzerland
Phone 2667 0
0041 31 632 21 11
Fax 2667 0
Email 2667 0
exataktylos@exadaktylos.ch

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.