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

Foot and Ankle Arthrodesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04812353
• Other study ID #: S56535
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2014
• Est. completion date: December 2022

Study information

• Verified date: March 2021
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 208
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Foot and Ankle Arthrodesis
• Foot and Ankle Osteotomy

Intervention

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

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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