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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON27003
Enrollment
378
Registered
2016-01-05
Start date
2014-05-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle, hindfoot, or midfoot fracture or (fracture) dislocation

Interventions

Not applicable, this is a questionnaire study.

Sponsors

Erasmus MC, University Medical Center Rotterdam, Trauma Research Unit, Department of Surgery Erasmus Medical Center, Medical Research Ethics Committee (MREC)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Group 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 criteria

Exclusion criteria: 1) Multiple trauma patient (if additional injury limits function at time of enrolment) 2) Pathological fracture 3) Severe physical comorbidity (ASA ¡Ý3) 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.

Design outcomes

Primary

MeasureTime frame
Content validity

Secondary

MeasureTime frame
Reliability (i.e., internal consistency, test-retest reliability, measurement error); Smallest detectable change; Floor and ceiling effect; Responsiveness.

Contacts

Public ContactE.M.M. van Lieshout

Erasmus MC, Trauma Research Unit, dept. of Surgery Mailbox H-822k 's-Gravendijkwal 230 3015 CE Rotterdam

E-mail e.vanlieshout@erasmusmc.nl+31-10 7031050

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)