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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Foot and Ankle Arthrodesis; Foot and Ankle Osteotomy
• Intervention / Treatment: Other: Follow-up of Io-Fix type fixation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 208
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

     Exclusion Criteria:

• Age under 18

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Foot and ankle arthrodesis or osteotomy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiological and clinical evaluation	Radiological and clinical evaluation will be combined to determine the fusion rate within a measured time span	within a period of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Form 36 Health Survey Questionnaire (SF-36)	To capture patients' perceptions of their own health and well-being	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	within a period of 1 year

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Arthrodesis; Osteotomy; Io-Fix system
• Other Study ID Numbers: S56535

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No