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

Primary Purpose

Calcaneocuboid Osteoarthritis Secondary to Trauma

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Calcaneocuboid arthrodesis
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Calcaneocuboid Osteoarthritis Secondary to Trauma

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assiut UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Screw fixation

Arm Description

Calcaneocuboid arthrodesis in triple arthrodesis by Screw fixation

Outcomes

Primary Outcome Measures

Assess calcaneocuboid arthrodesis union
calcaneocuboid arthrodesis union by RUST score

Secondary Outcome Measures

Full Information

First Posted
August 14, 2023
Last Updated
August 18, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT06003296
Brief Title
Calcaneocuboid Arthrodesis in Triple Arthrodesis by Plate Versus Screw: Randomized Controlled Trial
Official Title
Calcaneocuboid Arthrodesis in Triple Arthrodesis by Plate Versus Screw: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 10, 2023 (Anticipated)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
August 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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]

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcaneocuboid Osteoarthritis Secondary to Trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Screw fixation
Arm Type
Other
Arm Description
Calcaneocuboid arthrodesis in triple arthrodesis by Screw fixation
Intervention Type
Procedure
Intervention Name(s)
Calcaneocuboid arthrodesis
Intervention Description
Calcaneocuboid arthrodesis in triple arthrodesis
Primary Outcome Measure Information:
Title
Assess calcaneocuboid arthrodesis union
Description
calcaneocuboid arthrodesis union by RUST score
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdelrazik Talaat
Phone
01015828696
Email
Abdelraziktalaat@med.aun.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Amr A. Elfadle
Phone
01007788699
Email
Amr.a.mohamed@aun.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdelrazik Talaat
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut University
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdelrazik Talaat
Phone
01015828696
Email
Abdelraziktalaat@med.aun.edu.eg

12. IPD Sharing Statement

Learn more about this trial

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

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