NCT01586390

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 26, 2012

Completed
Last Updated

April 26, 2012

Status Verified

April 1, 2012

Enrollment Period

1.5 years

First QC Date

April 23, 2012

Last Update Submit

April 24, 2012

Conditions

Acute Ankle SprainAnkle Ligament RuptureAnkle Injuries

Keywords

Ankle SprainAnkle DistortionFunctional treatmentBrace treatment

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Pain

    follow-up of 4 months

  • Satisfaction score

    follow-up of 4 months

Study Arms (2)

MOK

EXPERIMENTAL

Adjustable and removable brace made out of Softcast material

Other: Ankle sprain treated with removable ankle support

WRAP

ACTIVE COMPARATOR

Softcast ankle cast

Other: Functional treatment for ankle sprain using ankle cast

Interventions

Functional treatment for ankle sprain using ankle castOTHER

Functional treatment for ankle sprain using ankle cast

WRAP
Ankle sprain treated with removable ankle supportOTHER

Ankle sprain functionally treated with removable and adjustable ankle support

MOK

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Grade 2 and 3 acute ankle sprains

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spaarneziekenhuis

Hoofddorp, 2134 TM, Netherlands

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Daniel Mensch, MD

    Spaarne Gasthuis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 23, 2012

First Posted

April 26, 2012

Study Start

June 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

April 26, 2012

Record last verified: 2012-04

Locations

NL(1)