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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01586390
Other study ID # WRAPvsMOK
Secondary ID
Status Completed
Phase Phase 2
First received April 23, 2012
Last updated April 24, 2012
Start date June 2009
Est. completion date December 2010

Study information

Verified date April 2012
Source Spaarne Ziekenhuis
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial Summary

In this study we compare two treatment options for ankle sprains. 100 patients were randomised between a flexible cast treatment and a removable and adjustable brace made out of the same materials.

Follow-up was 4 months. Primary outcome were functional scores. Secondary outcome measures were patient satisfaction scores with treatment as well as treatment result.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

• Grade 2 and 3 acute ankle sprains

Exclusion Criteria:

- history of ankle sprains with persistent instability

- grade I lateral ankle sprains

- ankle fracture

- bilateral ankle sprains

- previous ankle ligament surgery

- neuromuscular disorders of the lower extremities

- rheumatoid arthritis,

- alcoholism,

- serious psychiatric or neurological illness

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Functional treatment for ankle sprain using ankle cast
Functional treatment for ankle sprain using ankle cast
Ankle sprain treated with removable ankle support
Ankle sprain functionally treated with removable and adjustable ankle support

Locations

Country Name City State
Netherlands Spaarneziekenhuis Hoofddorp

Sponsors (1)

Lead Sponsor Collaborator
Spaarne Ziekenhuis

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Functional scores according to Karlsson score The modified KSS gives a score from 0-90 on perceived function of the ankle and foot, divided over eight topics relevant to daily function. The modified KSS at 4 months was the primary endpoint. Follow-up of 4 months No
Secondary Pain Measured by Visual analogue scale (1-10) follow-up of 4 months No
Secondary Satisfaction score satisfaction scores with treatment as well as treatment result on scale 1-10 follow-up of 4 months No
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