fracture ankle wrist calcaneus hindfoot foot 3D-RX trauma 3D-scan breuk fractuur enkel pols hielbeen voet
Conditions
Interventions
In first instance only 2D-fluoroscopy is used for the intra-operative imaging, as part of the usual intra-operative diagnostic procedure. The surgeon will then operate until (s)he is satisfied with fr
Sponsors
Trauma-Unit, department of Surgery
Academic Medical Center, Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients (age > 17 years) with a traumatic intra-articular ankle, calcaneus, or wrist fracture eligible for surgery according to the AMC-protocol for fractures in adults will be included. Randomization will be stratified for the different participating centers and the following fracture types: Distal radius fracture, AO-classification A1-C3; distal tibial fracture, AO-classification B1-C3; malleolar fractures, AO-classification A1-C3; and tongue type and joint depression type of calcaneus fractures.
Exclusion criteria
Exclusion criteria: 1. If they have pathological fractures, i.e. due to underlying malignant disorder; 2. When patients are unable to understand trial features due to mental or language handicap; 3. No written consent can be obtained.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For the first aim of the trial, the quality of fracture reduction and fixation of the ankle, calcaneus, or wrist will be assessed by a standard scoring protocol to judge fracture reduction and fixation. The postoperative CT-scans will be used for this score and will be judged by at least 5 experts. The scoring of the images will be in a blinded fashion and in random order. The scores of quality of fracture reduction and fixation will be compared between the intervention group and the control group. The second aim, the diagnostic value, will also be assessed according to a standard scoring protocol as mentioned above with the addition of scoring the image quality. The scores of the intra-operative 3D-scans and postoperative CT-scans will be compared. Judgement of the image quality and diagnostic value will be determined again by 5 experts, as explained above. | — |
Secondary
| Measure | Time frame |
|---|---|
| For the secondary outcomes the number and sort of complications will be recorded and the duration until full mobilization of the joint expressed in weeks. The clinical outcome will be determined by the range of motion in degrees and the DASH-score for the wrist and the FAOS-score for the ankle after 6 and 12 weeks and 1, 2 and 5 years postoperatively. | — |
Contacts
Public ContactR.J.O. De Muinck Keizer
Trauma Unit, Department of Surgery Academic Medical Center, Amsterdam
Outcome results
None listed