An interventional study of Follow-up of Io-Fix type fixation in Foot and Ankle Arthrodesis and Foot and Ankle Osteotomy, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Other
The recovery of foot and ankle arthrodesis and osteotomy is still plagued by the problem of delayed consolidation or even pseudo-arthrosis. To date, the foot and ankle unit of UZ Leuven is using a state of the art system, called the Io-Fix system, to optimize the biomechanical stability.
However, the current literature lacks studies assessing and quantifying the advantages of the Io-Fix system. Objective presentations about the use of, and (early) results are currently missing. Therefore, the investigators want to take their responsibility to objectively investigate whether they can confirm and quantify the expected positive results of using the Io-Fix system. Subsequently, the investigators want to search for eventual unexpected problems with Io-Fix.
The recovery of foot and ankle arthrodesis and osteotomy is still plagued by the problem of delayed consolidation or even pseudo-arthrosis. Some known risk factors for delayed consolidation are inherent to the patient and /or cannot be easily corrected by the surgeon: smoking, diabetes mellitus, use of NSAIDS, etc. Many other biological risk factors are well known. The fusion rate is one of these factors. This factor is influenced by the mechanical stability and compression at the level of arthrodesis. The right alignment till the moment of consolidation is an important factor as well.
Currently, two concepts leading to a better fusion rate are under investigation. First, research is done to optimize the local biological factors by using concentrated growth factors. Second, researchers are working towards optimal biomechanical stability and compression by further developing per-operative osteosynthesis material.
Following the optimal biomechanical stability concept, the following innovation was recently released: the Io-Fix system of Extremity Medical L.L.C. (Parsippany , NJ). This state of the art system has clear advantages compared to other systems. Based on the well-expected advantages, the Foot and Ankle unit of UZ Leuven has been using this system since more than one year. The initial subjective results with Io-Fix are strongly positive.
However, the current literature lacks studies assessing and quantifying the advantages of the Io-Fix system. Objective presentations about the use of, and (early) results are currently missing. Therefore, the investigators want to take their responsibility to objectively investigate whether they can confirm and quantify the expected positive results of using the Io-Fix system. Subsequently, the investigators want to search for eventual unexpected problems with Io-Fix.
However, the investigators believe that a larger study groups within a prospective framework with a longer follow-up is mandatory.
35 studies on the registry are indexed under Ankylosis; 17 are open to participants now.
This study's enrollment of 208 is above the median of 92 across 19 interventional studies indexed under Ankylosis.
Browse Ankylosis studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Being routinely scheduled for a reconstructive surgical procedure for the following indications or involving the following type of procedure
Exclusion Criteria:
Patients who underwent a foot- or ankle reconstruction surgery using the Io-Fix system
Other: Follow-up of Io-Fix type fixation
Follow-up of patients who underwent a foot- or ankle reconstruction surgery using the Io-Fix system
Radiological and clinical evaluation
Radiological and clinical evaluation will be combined to determine the fusion rate within a measured time span
Time frame: within a period of 1 year
Short Form 36 Health Survey Questionnaire (SF-36)
To capture patients' perceptions of their own health and well-being
Time frame: within a period of 1 year
American Orthopedic Foot and Ankle Score (AOFAS)
To measure the outcome of treatment in patients who sustained a complex ankle or hindfoot injury
Time frame: within a period of 1 year
Plan to share: Undecided
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Universitaire Ziekenhuizen KU Leuven