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Clinical Trials/NCT05795543
NCT05795543
Not yet recruiting
Not Applicable

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

Assiut University0 sites44 target enrollmentStarted: April 1, 2023Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
44
Primary Endpoint
Fusion rate

Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Fusion rate

Time Frame: 3 month

subtalar fusion radiologically and clinically

Secondary Outcomes

  • Functional assessment -rate of complications(e.g. non-union, post-operative infections, Instability) -secondary surgery procedures(3 month)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

mahmoud moustafa khalafallah ali

Qena, Eygpt

Assiut University

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