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Completed

NCT Number: NCT01770639

A Retrospective Study to Assess the Outcome After Surgical Reconstruction of the Midfoot With the Midfoot Fusion Bolt in Patients With Neuroarthropathy

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.

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Key information

Conditions

Charcot Neuroarthropathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Dresden, Dresden, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MFB

Procedure

Surgical arthrodesis of the midfoot with the Midfoot Fusion Bolt (MFB)

Primary outcomes

  1. Treatment failure within the first year after surgery

    Time frame: 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 outcomes

  1. Treatment failure within the first two years after surgery

    Time frame: 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.

  2. Adverse events related to the treatment or device under investigation

    Time frame: 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.

  3. Immobilization and non-weightbearing

    Time frame: Date of surgery to time of full weightbearing

    The duration and type of postoperative immobilization and the duration of postoperative non-weightbearing.

  4. Surgery details

    Time frame: Date of surgery

    Technical details of the midfoot reconstruction surgery .

  5. Foot angles

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AO Clinical Investigation and Publishing Documentation

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 18, 2013
Registry last updated
Jun 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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