cartilage damage charcot foot diabetic fractures neuropathic Osteoarthritis and cerebral palsy
Conditions
Interventions
 
Effect of the AFO, treatment and WBCT. 
Sponsors
Amsterdam UMC
Eligibility
Age
2 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria:Group 1-6: Patients diagnosed with (1) Ankle osteoarthritis, (2) Neuropathic foot, with or without Charcot, (3) Osteochondral defects, (4) Acute ankle and foot trauma, (5) Claw or hammer toes or (6) chronic ankle instability must be 18 years or older, have sufficient understanding of Dutch/English language, and be capable of filling out informed consent and questionnaires.Group 7 (calcaneal fractures): subjects must 1) be 18 years or older, 2) have sustained an intra-articular dislocated calcaneal fracture 1-1,5 years ago, 3) have under-gone surgical treatment (fixation/arthrodesis), 4) have sufficient understanding of Dutch/English language, 5) be capable of filling out informed consent and questionnaires.Group 8 (CP): subjects must 1) be 4 to 18 years old, 2) have a clinical diagnosis of CP or related diagnoses (i.e., hereditary spastic paresis or spastic paresis e.c.i.), 3) have an AFO (uni- or bilateral), which is provided by (the orthotist at) Amsterdam UMC, and 4) be able to stand upright during the scans (if necessary with some support).Healthy controls with no history of ankle pathology must have sufficient understanding of Dutch/English language, and be capable of filling out informed consent (if older than 12) and questionnaires. Healthy controls, which will be recruited using flyers (Figure 5, add.2), are able to get in contact with the research coordinator using the contact details on the flyer.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:Patients:No written informed consentNot meeting the inclusion criteriaPrevious participation in the studyPregnant womenInability to stand in the upright positionConcomitant participation in a study in which the patient is exposed to X-raysSpecifically for group 7 (calcaneal fractures), additional exclusion criteria are 1) injuryto ipsi/contralateral side substantially impairing mobilisation and 2) having undergonea secondary arthrodesis after fracture fixation.Specifically for group 8 (CP), additional exclusion criteria are 1) prior interventionsinfluencing the foot, including bony orthopedic surgery, tendon transposition of a muscle attached to the foot, muscle-tendon lengthening surgery of a muscle attached to the foot in the past two years, serial casting in the lower extremities in the past six weeks, or Botulinum toxin-A injections of a muscle attached to the foot in the past three months, and 2) Selective Dorsal Rhizotomy surgery in the past year.Healthy controls:No written informed consentNot meeting the inclusion criteriaHistory of ankle pathologyPrevious participation in the studyPregnant womenInability to stand in the upright positionConcomitant participation in a study in which the patient is exposed to X-rays
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters are a weight-bearing and non-weight-bearing CT of the ankle. The main endpoints are quantitative outcomes regarding the location, displacement and rotation of individual bone fragments, joint space measurements and pressure measurements under the foot. The contralateral ankle/foot and healthy controls will be used as a reference. Data will be compared within patients and between patients and healthy controls. For the children with CP, a comparison between weight-bearing scans with AFO and without AFO will be made. In group 8, also a comparison is made between the weight-bearing CT scans with and without AFO. | — |
Secondary
| Measure | Time frame |
|---|---|
| Other study parameters are age, sex, weight and body mass index since these parameters may affect the status and loading of the ankle. The PROMs will include the Eurogol 5D questionnaire (EQ-5D) and the Functional Foot Index (FFI). For group 8 a custom questionnaire will be included that will be completed by the children together with their parents; in addition, the Foot Posture Index (FPI) will be determined to quantify the foot deformity. Some additional specific information on the AFOs and shoes (type, material, custom foot correction) will also be collected by inspection and/or extraction from EPIC or (if necessary) the orthotist of the AFOs (OIM Orthopedie). Information on previous interventions (see 4.3 Exclusion criteria) will also be extracted from EPIC. | — |
Countries
Netherlands
Contacts
Public ContactRHH Wellenberg
Amsterdam UMC
Outcome results
None listed