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

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06003296
Collaborator
(none)
3
1
1
34.7
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Calcaneocuboid arthrodesis
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
3 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Calcaneocuboid Arthrodesis in Triple Arthrodesis by Plate Versus Screw: Randomized Controlled Trial
Anticipated Study Start Date :
Sep 10, 2023
Anticipated Primary Completion Date :
Aug 1, 2025
Anticipated Study Completion Date :
Aug 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Other: Screw fixation

Calcaneocuboid arthrodesis in triple arthrodesis by Screw fixation

Procedure: Calcaneocuboid arthrodesis
Calcaneocuboid arthrodesis in triple arthrodesis

Outcome Measures

Primary Outcome Measures

  1. Assess calcaneocuboid arthrodesis union [One year]

    calcaneocuboid arthrodesis union by RUST score

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut University Assiut Egypt

Sponsors and Collaborators

  • Assiut University

Investigators

  • Principal Investigator: Abdelrazik Talaat, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abdelrazik Talaat Abdelrazik Khalifa, Assiut, Assiut University
ClinicalTrials.gov Identifier:
NCT06003296
Other Study ID Numbers:
  • Calcaneocuboid arthrodesis
First Posted:
Aug 21, 2023
Last Update Posted:
Aug 21, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2023