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

NCT ID: NCT06003296

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-10
• Study Completion Date: 2026-08-01

Brief Summary

Investigators aim to compare clinical and radiological outcome of use of plate versus screw fixation for calcaneocuboid arthrodesis in adult population.

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]

Conditions

Calcaneocuboid Osteoarthritis Secondary to Trauma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Screw fixation

Calcaneocuboid arthrodesis in triple arthrodesis by Screw fixation

Group Type: OTHER

Calcaneocuboid arthrodesis

Intervention Type: PROCEDURE

Calcaneocuboid arthrodesis in triple arthrodesis

Interventions

Calcaneocuboid arthrodesis

Calcaneocuboid arthrodesis in triple arthrodesis

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Abdelrazik Talaat Abdelrazik Khalifa

Assiut

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdelrazik Talaat

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Assiut University

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Abdelrazik Talaat

Role: CONTACT

Abdelraziktalaat@med.aun.edu.eg

01015828696

Amr A. Elfadle

Role: CONTACT

Amr.a.mohamed@aun.edu.eg

01007788699

Facility Contacts

Abdelrazik Talaat

Role: primary

Abdelraziktalaat@med.aun.edu.eg

01015828696

Other Identifiers

Calcaneocuboid arthrodesis

Identifier Type: -

Identifier Source: org_study_id