Subtalar Arthrodesis by Single Versus Double Screws
Primary Purpose
Subtalar Osteoarthritis Secondary to Inflammatory Arthritis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Subtalar Arthrodesis by Screws
Sponsored by
About this trial
This is an interventional treatment trial for Subtalar Osteoarthritis Secondary to Inflammatory Arthritis focused on measuring subtalar arthrodesis, screws
Eligibility Criteria
Inclusion Criteria: All patients who will be operated by subtalar fusion for any indication Age range 18 - 65 Exclusion Criteria: Age < 18 years , > 65 Acute calceneal fracture Infection Non union Bone defect that need bone graft Refusing to participate in the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
A
B
Arm Description
subtalar arthrodesis by single screw
subtalar arthrodesis by double screws
Outcomes
Primary Outcome Measures
Fusion rate
subtalar fusion radiologically and clinically
Secondary Outcome Measures
Functional assessment -rate of complications(e.g. non-union, post-operative infections, Instability) -secondary surgery procedures
by AOFAS Ankle-Hindfoot Scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05795543
Brief Title
Subtalar Arthrodesis by Single Versus Double Screws
Official Title
Single Versus Double Screws Fixation of Subtalar Arthrodesis : A Prospective Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
December 2024 (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
5. Study Description
Brief Summary
Compare clinical and radiological outcome of use of single screw versus double screws fixation for subtalar arthrodesis
Detailed Description
The subtalar joint consists of an anterior, posterior and medial joint facet, which allows for inversion - and eversion of the foot. Several pathologies may lead to pain originating from the subtalar joint, including primary arthritis, posttraumatic arthritis, congenital or acquired deformities, instability, tarsal coalition or inflammatory diseases Management of these pathologies variable including conservative and operative treatment once conservative treatment has failed subtalar fusion is a common surgical procedure which is a well-established and widely accepted There are many surgical techniques described for fusion , one of these techniques is fixation with screws The rate of non-union varies among authors between 0-46%, that's may due to lack of standardization of techniques should be used
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subtalar Osteoarthritis Secondary to Inflammatory Arthritis
Keywords
subtalar arthrodesis, screws
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
participant divide to 2 groups first group subtalar arthrodesis by single screw second group subtalar arthrodesis by double screws
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
subtalar arthrodesis by single screw
Arm Title
B
Arm Type
Active Comparator
Arm Description
subtalar arthrodesis by double screws
Intervention Type
Procedure
Intervention Name(s)
Subtalar Arthrodesis by Screws
Intervention Description
Instruments: cannulated screws Steps: supine position , tournique over the thigh, using a extended lateral approach or sinus tarsi approach with joint debridement and preparation. Single-screw fixation was most often placed from posterior to anterior and double screws fixation was placed triangular pattern
Primary Outcome Measure Information:
Title
Fusion rate
Description
subtalar fusion radiologically and clinically
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Functional assessment -rate of complications(e.g. non-union, post-operative infections, Instability) -secondary surgery procedures
Description
by AOFAS Ankle-Hindfoot Scale
Time Frame
3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients who will be operated by subtalar fusion for any indication Age range 18 - 65
Exclusion Criteria:
Age < 18 years , > 65 Acute calceneal fracture Infection Non union Bone defect that need bone graft Refusing to participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud M khalafallah, master
Phone
01117513794
Email
Mahmoud.20134334@med.aun.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Wael Y El-adly, professor
Phone
01224265850
Email
eladlyw@aun.edu.eg
12. IPD Sharing Statement
Citations:
PubMed Identifier
31522872
Citation
Wirth SH, Viehofer A, Fritz Y, Zimmermann SM, Rigling D, Urbanschitz L. How many screws are necessary for subtalar fusion? A retrospective study. Foot Ankle Surg. 2020 Aug;26(6):699-702. doi: 10.1016/j.fas.2019.08.017. Epub 2019 Sep 6.
Results Reference
background
PubMed Identifier
8919403
Citation
Buch BD, Myerson MS, Miller SD. Primary subtaler arthrodesis for the treatment of comminuted calcaneal fractures. Foot Ankle Int. 1996 Feb;17(2):61-70. doi: 10.1177/107110079601700202.
Results Reference
background
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Subtalar Arthrodesis by Single Versus Double Screws
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