An observational study in Charcot Neuroarthropathy and Diabetic Foot, sponsored by AO Clinical Investigation and Publishing Documentation. Completed at 3 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-25.
Sponsored by AO Clinical Investigation and Publishing Documentation · Observational
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.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 47 is below the median of 100 across 186 observational studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →AO Clinical Investigation and Publishing Documentation is the lead sponsor of 49 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with neuro-osteoarthropathy of the foot or with other neurological impairment in combination with foot deformity who have previously undergone surgical reconstruction of the midfoot with the Midfoot Fusion Bolt.
Neuroarthropathy Deformity of the foot with neurological impairment - Signed informed consent according to local regulation
Exclusion Criteria:
Surgical arthrodesis of the midfoot with the Midfoot Fusion Bolt (MFB)
Procedure: MFB
Surgical arthrodesis of the midfoot with the Midfoot Fusion Bolt (MFB)
Treatment failure within the first year after surgery
The occurrence and the date of a secondary surgical intervention for correction of deformity or an amputation within the first year after surgery.
Time frame: Date of surgery to 1 year posto-op
Treatment failure within the first two years after surgery
The occurrence and the date of a secondary surgical intervention for correction of deformity or an amputation within the first two years after surgery.
Time frame: Date of surgery to 2 years post-op
Adverse events related to the treatment or device under investigation
The occurrence, type, and date of adverse events related to the midfoot arthrodesis or the MFB within the first two years after surgery.
Time frame: Date of surgery to 2 years post-op
Immobilization and non-weightbearing
The duration and type of postoperative immobilization and the duration of postoperative non-weightbearing.
Time frame: Date of surgery to time of full weightbearing
Surgery details
Technical details of the midfoot reconstruction surgery .
Time frame: Date of surgery
Foot angles
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.
Time frame: Pre-op, post-op, 6w, 12w, 6m, 12m
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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AO Clinical Investigation and Publishing Documentation