Charcot Neuroarthropathy, Diabetic Foot
Conditions
Keywords
charcot foot, charcot neuroarthropathy, midfoot arthrodesis, midfoot fusion
Brief summary
The aim of this study is to investigate the clinical outcomes of surgical correction of foot deformity with the MFB in a larger group of patients with neurological impairment of the foot.
Interventions
PROCEDUREMFB
Surgical arthrodesis of the midfoot with the Midfoot Fusion Bolt (MFB)
Sponsors
AO Clinical Investigation and Publishing Documentation
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 at date of inclusion * Previous surgical reconstruction of the midfoot with Midfoot Fusion Bolt(s) for one of the following indications: Neuroarthropathy Deformity of the foot with neurological impairment - Signed informed consent according to local regulation
Exclusion criteria
\- Prisoner at date of inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment failure within the first year after surgery | Date of surgery to 1 year posto-op | The occurrence and the date of a secondary surgical intervention for correction of deformity or an amputation within the first year after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment failure within the first two years after surgery | Date of surgery to 2 years post-op | The occurrence and the date of a secondary surgical intervention for correction of deformity or an amputation within the first two years after surgery. |
| Adverse events related to the treatment or device under investigation | Date of surgery to 2 years post-op | The occurrence, type, and date of adverse events related to the midfoot arthrodesis or the MFB within the first two years after surgery. |
| Immobilization and non-weightbearing | Date of surgery to time of full weightbearing | The duration and type of postoperative immobilization and the duration of postoperative non-weightbearing. |
| Surgery details | Date of surgery | Technical details of the midfoot reconstruction surgery . |
| Foot angles | Pre-op, post-op, 6w, 12w, 6m, 12m | Talus-first metatarsal angle and calcaneus-fifth metatarsal angle on the AP and lateral x-rays of the affected foot before surgery, immediately after surgery, 6 weeks, 12 weeks, 6 months, and 12 months after surgery. |
Countries
Germany
Outcome results
None listed