Weight-bearing CT for musculoskeletal disorders

Recruiting

Conditions: Diabetische, neuropathische en Charcot voet.
cartilage damage
charcot foot
diabetic
fractures
neuropathic
Osteoarthritis
10023213
10005944

Registration Number: NL-OMON48452

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 180

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, (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.;Healthy controls with no history of ankle pathology must be 18 years or older, have sufficient understanding of Dutch/English language, and be capable of filling out informed consent and questionnaires. Healthy controls, which will be recruited using flyers (Figure 5), are able to get in contact with the research coordinator using the contact details on the flyer. ;The research coordinator will screen if the patients and healthy controls meet the inclusion criteria.

Exclusion Criteria

Patients:
- No written informed consent
- Not meeting the inclusion criteria
- Previous participation in the study
- Pregnant women
- Inability to stand in the upright position
- Concomitant participation in a study in which the patient is exposed to X-rays
- Specifically for group 7 (calcaneal fractures), additional exclusion criteria are 1) injury to ipsi/contralateral side substantially impairing mobilisation and 2) having undergone a secondary arthrodesis after fracture fixation.;Healthy controls:
- No written informed consent
- Not meeting the inclusion criteria
- History of ankle pathology
- Previous participation in the study
- Pregnant women
- Inability to stand in the upright position
- Concomitant participation in a study in which the patient is exposed to X-rays

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters are a weight-bearing and non-weight-bearing CT of the<br /><br>ankle. The main endpoints are quantitative outcomes regarding the location,<br /><br>displacement and rotation of individual bone fragments, joint space<br /><br>measurements and pressure measurements under the foot. The contralateral<br /><br>ankle/foot and healthy controls will be used as a reference. Data will be<br /><br>compared within patients and between patients and healthy controls.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Other study parameters are age, sex, weight and body mass index since these<br /><br>parameters may affect the status and loading of the ankle. The PROMs will<br /><br>include the Eurogol 5D questionnaire (EQ-5D) and the Functional Foot Index<br /><br>(FFI). </p><br>