Viewing Study NCT06584487



Ignite Creation Date: 2024-10-26 @ 3:39 PM
Last Modification Date: 2024-10-26 @ 3:39 PM
Study NCT ID: NCT06584487
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-08-14

Brief Title: Proximal Metatarsal Osteotomy in Correction of Hallux Valgus
Sponsor: None
Organization: None

Study Overview

Official Title: Proximal Metatarsal Medial Opening Wedge Osteotomy Fixed by Plate and Screws in Correction of Hallux Valgus
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The outcomes of the correction of hallux valgus by proximal opening wedge osteotomy
Detailed Description: Hallux valgus is a common cause of foot pain and deformity in the adult and adolescent population which often requires surgical treatment when nonsurgical treatments fail

During the past decades multiple modified procedures and fixation techniques have been described

The most common types of osteotomies of the first metatarsal are crescentic chevron scarf and lateral or medial opening wedge techniques

A concern with the Chevron and other distal osteotomies is the development of avascular necrosis of the first metatarsal head with a reported incidence of between 0 and 20

On the other side the proximal dome osteotomy along with a distal soft tissue release is an excellent procedure The proximal location of the osteotomy avoids devascularization of the metatarsal head and the crescent shape maintains the length of the metatarsal It allows a high degree of correction at the intermetatarsal angle in severe deformities

When the condition is associated with an increased intermetatarsal angle a surgical technique using a proximal first metatarsal osteotomy is often indicated A proximal opening wedge osteotomy stabilized with a wedge and plate configuration offers a stable reliable means to correct the increased intermetatarsal angle

Over the past 10 years some surgeons have increasingly used locking plates instead of a single screw for stabilisation of the osteotomy with the assumption of better postoperative stability and preserved length of the first metatarsal In addition fixation with a plate has been described as technically less challenging

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None