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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-01

Study Completion Date

2025-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Foot and Ankle Arthrodesis Foot and Ankle Osteotomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Foot and ankle arthrodesis or osteotomy

Patients who underwent a foot- or ankle reconstruction surgery using the Io-Fix system

Group Type OTHER

Follow-up of Io-Fix type fixation

Intervention Type OTHER

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

Interventions

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Follow-up of Io-Fix type fixation

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Being routinely scheduled for a reconstructive surgical procedure for the following indications or involving the following type of procedure

1. Any reconstructive procedure for Pes Planus, Pes Plano-valgus, or Posterior Tibial Tendon Dysfunction
2. Tibio-talar arthrodesis or prosthesis
3. Sub-talar -and/or (partial) Chopart - and/or Triple arthrodesis
4. Pantalar arthrodesis with or without inclusion of the Chopart joint