Subtalar Arthrodesis by Single Versus Double Screws

NCT ID: NCT05795543

Last Updated: 2023-04-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-12-31

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

Conditions

Subtalar Osteoarthritis Secondary to Inflammatory Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

subtalar arthrodesis by single screw

Group Type: ACTIVE_COMPARATOR

Subtalar Arthrodesis by Screws

Intervention Type: PROCEDURE

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

B

subtalar arthrodesis by double screws

Group Type: ACTIVE_COMPARATOR

Subtalar Arthrodesis by Screws

Intervention Type: PROCEDURE

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

Interventions

Subtalar Arthrodesis by Screws

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

mahmoud moustafa khalafallah ali

Qena, Eygpt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mahmoud M khalafallah, master

Role: CONTACT

Mahmoud.20134334@med.aun.edu.eg

01117513794

Wael Y El-adly, professor

Role: CONTACT

eladlyw@aun.edu.eg

01224265850

References

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.

Reference Type: BACKGROUND

PMID: 31522872 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8919403 (View on PubMed)

Other Identifiers

subtalar arthrodesis

Identifier Type: -

Identifier Source: org_study_id