Functional Treatment for Acute Ankle Sprains: Softcast Wrap Versus MOKcast

Ankle Injuries Clinical Trial

Official title:

Functional Treatment for Acute Ankle Sprains: Softcast Wrap Versus MOKcast. A Prospective Randomized Single-centre Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01586390
• Other study ID #: WRAPvsMOK
• 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

• Acute Ankle Sprain
• Ankle Injuries
• Ankle Ligament Rupture

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