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van CCT (UK)


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van CCT (UK)


A prediction model for chronic ankle instability.


- candidate number25459
- NTR NumberNTR6139
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-okt-2016
- Secondary IDsW16_258 # 16.303  
- Public TitleA prediction model for chronic ankle instability.
- Scientific TitleA Prediction Model for Chronic Ankle Instability: indications for early surgical treatment? An observational prospective cohort
- ACRONYMPredict
- hypothesisBoth personal factors and joint geometry contribute to the development of chronic ankle instability.
- Healt Condition(s) or Problem(s) studiedAnkle instability
- Inclusion criteriaAt least 18 years old
Visited the ER within one week after a lateral ankle sprain
An AP and lateral x-ray have been made
Agreed with being approached for this study
Questionnaires have been returned within 4 weeks
Reported lateral ankle pain after an ankle sprain or ankle distortion ankle
- Exclusion criteriaPresent fracture or other joint pathology/bone matrix pathology
A diagnosed OCD after primary inclusion
Medial ankle instability
Previous ankle surgery
An unreliable x-ray due to the angle in which it is made or low quality
Acute surgical repair of the ATFL/CFL or another form of surgery within 6 months after the initial ankle sprain
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-okt-2016
- planned closingdate1-jan-2020
- Target number of participants1500
- InterventionsNone
- Primary outcomeA predictionmodel based on patient specific characteristics and ankle joint geometry.
- Secondary outcomeInter- and intrarater reliability of assessment of the joint geometry on x-rays.
Correlation of acute symptoms after the ankle sprain with recovery
Correlation of treatment given after the ankle sprain with recovery
Improvement of FAOS and CAIT score over time after a visit to the Emergency Department (ER)
- TimepointsQuestionnaires will be sent 2 weeks after the ER visit, and after 3 and 6 months.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESPhD-Candidate Gwendolyn Vuurberg
- CONTACT for SCIENTIFIC QUERIESPhD-Candidate Gwendolyn Vuurberg
- Sponsor/Initiator Academic Medical Center (AMC) De Meren, VU University Medical Center, MC Slotervaart, Flevo Hospital, Onze Lieve Vrouwe Gasthuis (OLVG)
- Funding
(Source(s) of Monetary or Material Support)
None
- PublicationsNo publications so far
- Brief summaryChronic ankle instability is a common result of an ankle sprain. The patients we see at the orthopaedics department often suffer from complaints for an unnessesarily long period of time. Additionally the longer the period of complaints and recurrent sprains, the lower the chance of surgical succes. We are going to develop a prediction model to assess which factors contribute to chronicity. This way patients with a greater chance on chronic instability can be identified and may become eligible for early surgical stabilization.
- Main changes (audit trail)
- RECORD26-okt-2016 - 3-jan-2017


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