Subtalar Arthrodesis by Single Versus Double Screws

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05795543

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Compare clinical and radiological outcome of use of single screw versus double screws fixation for subtalar arthrodesis

Condition or Disease	Intervention/Treatment	Phase
Subtalar Osteoarthritis Secondary to Inflammatory Arthritis	Procedure: Subtalar Arthrodesis by Screws	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

participant divide to 2 groups first group subtalar arthrodesis by single screw second group subtalar arthrodesis by double screwsparticipant divide to 2 groups first group subtalar arthrodesis by single screw second group subtalar arthrodesis by double screws

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Single Versus Double Screws Fixation of Subtalar Arthrodesis : A Prospective Randomized Controlled Study

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A subtalar arthrodesis by single screw	Procedure: 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
Active Comparator: B subtalar arthrodesis by double screws	Procedure: 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

Arm

Intervention/Treatment

Active Comparator: A

subtalar arthrodesis by single screw

Procedure: 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

Active Comparator: B

subtalar arthrodesis by double screws

Procedure: Subtalar Arthrodesis by Screws

Outcome Measures

Primary Outcome Measures

Fusion rate [3 month]
subtalar fusion radiologically and clinically

Secondary Outcome Measures

Functional assessment -rate of complications(e.g. non-union, post-operative infections, Instability) -secondary surgery procedures [3 month]
by AOFAS Ankle-Hindfoot Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

mahmoud moustafa khalafallah ali, Qena, Eygpt, Assiut University

ClinicalTrials.gov Identifier:

NCT05795543

Other Study ID Numbers:

subtalar arthrodesis

First Posted:

Apr 3, 2023

Last Update Posted:

Apr 3, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by mahmoud moustafa khalafallah ali, Qena, Eygpt, Assiut University

subtalar arthrodesis

screws

Additional relevant MeSH terms:

Arthritis

Study Results

No Results Posted as of Apr 3, 2023