Calcaneocuboid Arthrodesis in Triple Arthrodesis by Plate Versus Screw: Randomized Controlled Trial

August 18, 2023 updated by: Abdelrazik Talaat Abdelrazik Khalifa, Assiut University
Investigators aim to compare clinical and radiological outcome of use of plate versus screw fixation for calcaneocuboid arthrodesis in adult population.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The calcaneocuboid joint is stable, even although multiple conditions might affect the joint, ranging from osteoarthritis to fracture, subluxation, and dislocation. Calcaneocuboid arthrodesis is more commonly performed as an adjunct procedure with other rearfoot procedures such as triple arthrodesis and is less used as isolated fusion.[1],[2],[3] What the most effective and least cost method for calcaneocuboid arthrodesis?! Many conditions that may affect foot that cause pain ; and there are many methods for relieve that pain , one of these is arthrodesis , and calcaneocuboid joint one of the most affected joints , and commonly we do calcaneocuboid arthrodesis as a part of triple arthrodesis ( subtalar , talonavicular , calcaneocuboid ); The traditional fixation for a calcaneocuboid (CC) arthrodesis in triple arthrodesis is with a 6.5-mm cancellous screw. This procedure can be technically challenging. Fixation with a locking compression plate (LCP) may be easier to perform while achieving compression perpendicular to the fusion site. Investigators suppose that plate is more powerful than screw in calcaneocuboid arthrodesis. The purpose of this study was to compare the load to failure and the stiffness for each fixation method. [4],[5],[6] literature reveal that: More stability to the fusion site can be applied by using plate fixation. Rationale of the research that: calcaneocuboid arthrodesis with screw is effective and least cost compare to plate fixation? [7]

Study Type

Interventional

Enrollment (Estimated)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

all patients who will be operated by calcaneocuboid fusion for any indication age range 18-65 no paralytic patients

Exclusion Criteria:

  • age < 18 , > 65 acute calcaneal fracture infection non union bone defect that need bone graft refusing to participate in the study neuropathic patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Screw fixation
Calcaneocuboid arthrodesis in triple arthrodesis by Screw fixation
Procedure: Calcaneocuboid arthrodesis
Calcaneocuboid arthrodesis in triple arthrodesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess calcaneocuboid arthrodesis union
Time Frame: One year
calcaneocuboid arthrodesis union by RUST score
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Abdelrazik Talaat, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 10, 2023

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

August 14, 2023

First Submitted That Met QC Criteria

August 18, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 18, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Calcaneocuboid arthrodesis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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