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The American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot and Midfoot Scores; Translation and Validation of the Dutch Language Versions


- candidate number23566
- NTR NumberNTR5613
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-jan-2016
- Secondary IDsMEC-2014-215 (METC Erasmus MC) 
- Public TitleThe American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot and Midfoot Scores; Translation and Validation of the Dutch Language Versions
- Scientific TitleThe American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot and Midfoot Scores; Translation and Validation of the Dutch Language Versions
- ACRONYMAOFAS-DLV
- hypothesisWe expect that the Dutch language versions of the AOFAS Ankle-Hindfoot and the AOFAS Midfoot score will have adequate measurement properties (e.g. reliability and validity).
- Healt Condition(s) or Problem(s) studiedAnkle fracture, Ankle
- Inclusion criteriaGroup 1 (test of pre-final version):
1) Patients with a unilateral ankle, hindfoot, or midfoot fracture or (fracture) dislocation
a. Ankle-Hindfoot: ankle fracture, calcaneal fracture, talar fracture, subtalar dislocation, tibiotalar dislocation, or Chopart's fracture dislocation
b. Midfoot: cuboid fracture, navicular fracture, cuneiform fracture, or Lisfranc (fracture) dislocation
2) Age 18 years or older
3) Provision of informed consent by patient.

Group 2 (validity and (test-retest) reliability):
1) Patients with a unilateral ankle, hindfoot or midfoot fracture or (fracture) dislocation
a) Ankle: ankle fracture
b) Hindfoot: calcaneal fracture, talar fracture, subtalar dislocation, tibiotalar dislocation, or Chopart's fracture dislocation
c) Midfoot: cuboid fracture, navicular fracture, cuneiform fracture, or Lisfranc (fracture) dislocation
2) Treatment started between seven and nine months (ankle and midfoot) or between six and 24 months (hindfoot) prior to the start of the study
3) Age 18 years or older
4) Povision of informed consent by patient.

Group 3 (validity and responsiveness):
1) Patients with a unilateral ankle or hindfoot fracture (as defined for group 2 above)
2) Treatment started between six weeks and three months (ankle and midfoot) or between three and six months (hindfoot) prior to the start of the study
3) Age 18 years or older
4) Provision of informed consent by patient.
- Exclusion criteria1) Multiple trauma patient (if additional injury limits function at time of enrolment)
2) Pathological fracture
3) Severe physical comorbidity (ASA °›3)
4) Patient was non-ambulatory prior to the injury
5) Insufficient comprehension of the Dutch language to understand and complete the questionnaires
6) Patients with expected problems of maintaining follow-up

For testing the pre-final version of the Dutch AOFAS Ankle-Hindfoot or Midfoot Score (group 1), only exclusion criteria 5 and 6 will apply.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mei-2014
- planned closingdate31-dec-2017
- Target number of participants378
- InterventionsNot applicable, this is a questionnaire study.
- Primary outcomeContent validity
- Secondary outcomeReliability (i.e., internal consistency, test-retest reliability, measurement error); Smallest detectable change; Floor and ceiling effect; Responsiveness.
- TimepointsTest-retest analysis:
1)7-9 months (ankle or midfoot) or 6-24 months (hindfoot) after injury
2) 2-3 weeks after first completion.

Responsiveness analysis:
1) between 6 weeks and 3 months (ankle or midfoot) or between 3 and 6 months (hindfoot) after injury
2) 5-6 months after first completion.
- Trial web siteNone.
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc PhD E.M.M. van Lieshout
- CONTACT for SCIENTIFIC QUERIESMSc PhD E.M.M. van Lieshout
- Sponsor/Initiator Erasmus MC, Trauma Research Unit department of Surgery, Erasmus Medical Center, Medical Ethical Committee (METC)
- Funding
(Source(s) of Monetary or Material Support)
None
- PublicationsNone yet; study is ongoing
- Brief summaryBACKGROUND Patient-Reported Outcome Measures (PROMs) are increasingly used in order to measure (functional) recovery over time from a patientís perspective. The AOFAS Ankle-Hindfoot Score is the most commonly used PROM for measuring outcome of treatment in patients who sustained a complex ankle or hindfoot injury. Similarly, the AOFAS Midfoot Score is a commonly used PROM for measuring outcome of treatment in patients who sustained a midfoot fracture or (fracture) dislocation. A valid, Dutch version of these instruments is currently not yet available. Such translated and validated PROMs will allow objective comparison across hospitals and with shown validity and reliability it may become a quality of care indicator in future.

AIM 1) To translate and culturally adept the AOFAS Ankle-Hindfoot Score and AOFAS Midfoot Score questionnaires into Dutch according to international guidelines, 2) to evaluate the measurement properties of the AOFAS Ankle-Hindfoot Score-Dutch Language Version (DLV) in patients with a unilateral ankle or hindfoot fracture or (fracture) dislocation, and 3) to evaluate the measurement properties of the AOFAS Midfoot Score-DLV in patients with a unilateral midfoot fracture or (fracture) dislocation.

STUDY DESIGN Multicenter, prospective observational study.

POPULATION Adult patients (18 years or older) presenting to the Emergency Department with a unilateral ankle, hindfoot, or midfoot fracture or (fracture) dislocation.

INTERVENTION Not applicable, this is a questionnaire study.

ENDPOINTS Measurement properties of the AOFAS Ankle-Hindfoot Score-DLV and the AOFAS Midfoot Score-DLV will be determined. Primary outcome measure is the content validity. Secondary outcome measures include the reliability (i.e., internal consistency, test-retest reliability, measurement error), smallest detectable change, floor and ceiling effect, and responsiveness.

RECRUITING COUNTRIES The Netherlands.
- Main changes (audit trail)
- RECORD5-jan-2016 - 14-feb-2016


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