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NCT Number: NCT04812353

Foot and Ankle Arthrodesis or Osteotomy With Io-Fix Type Fixation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Being routinely scheduled for a reconstructive surgical procedure for the following indications or involving the following type of procedure
  • Any reconstructive procedure for Pes Planus, Pes Plano-valgus, or Posterior Tibial Tendon Dysfunction
  • Tibio-talar arthrodesis or prosthesis
  • Sub-talar -and/or (partial) Chopart - and/or Triple arthrodesis
  • Pantalar arthrodesis with or without inclusion of the Chopart joint

Exclusion criteria

  • Age under 18

Treatment and study plan

Follow-up of Io-Fix type fixation

Other

Follow-up of patients who underwent a foot- or ankle reconstruction surgery using the Io-Fix system

Primary outcomes

  1. Radiological and clinical evaluation

    Time frame: within a period of 1 year

    Radiological and clinical evaluation will be combined to determine the fusion rate within a measured time span

Secondary outcomes

  1. Short Form 36 Health Survey Questionnaire (SF-36)

    Time frame: within a period of 1 year

    To capture patients' perceptions of their own health and well-being

  2. American Orthopedic Foot and Ankle Score (AOFAS)

    Time frame: within a period of 1 year

    To measure the outcome of treatment in patients who sustained a complex ankle or hindfoot injury

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Foot and Ankle Arthrodesis or Osteotomy With Io-Fix Type Fixation : a Prospective Study

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Mar 23, 2021
Registry last updated
Jul 10, 2026

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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