Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06302530
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-02-12
Brief Title:
Effectiveness of the Ultrasound - Guided Lengthening of the Gastrocsoleus Complex
Sponsor:
Fundación Universidad Católica de Valencia San Vicente Mártir
Organization:
Fundación Universidad Católica de Valencia San Vicente Mártir
Study Overview
Official Title:
Effectiveness of the Ultrasound - Guided Lengthening of the Gastrocsoleus Complex
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EUGLGC
Brief Summary:
This research project compares the effectiveness of different surgical techniques for lengthening the gastrocnemius-soleus system in patients with equinus deformity The study will compare 2 techniques gastrocnemius tendon recession Strayer and plantaris resection Increased ankle range of motion complications operative time recovery time pain scales and function will be measured The results will help determine which technique is most effective and safe for correcting equinus deformity
Detailed Description:
Equinus deformity is a common deformity caused by contracture of the triceps suralis especially the gastrocnemius This causes limitation of ankle dorsiflexion pain and gait incompetence Treatment includes surgical lengthening techniques such as gastrocnemius tendon recession Strayer or isolated plantar tendon transection
The minimally invasive Strayer technique is effective but carries morbidity Ultrasound-guided plantar tendon transection is a new minimally invasive technique but its effectiveness has not been well established
The aim of this study is to compare the efficacy and safety of the Strayer technique versus isolated plantar tendon transection in the surgical treatment of the equinus deformity The results will help determine the best surgical option for increasing ankle range of motion in these patients
To compare the effectiveness of the Strayer technique gastrocnemius tendon recession versus plantar tendon transection in patients with equinus deformity
Patients will be divided into two groups
Group 1 Patients with isolated gastrocnemius contracture undergoing Strayer technique This consists of ultrasound-guided recession of the gastrocnemius tendon distally
Group 2 Patients with mild contracture undergoing ultrasound-guided plantar tendon transection of the medial aspect of the gastrocnemius
The main variables will be the increase in the range of mobility of the ankle measured with a goniometer before and after surgery Pain will also be evaluated with visual analogue scale function with American Orthopaedic Foot and Ankle Society AOFAS Ankle-Hindfoot Score scale complications and surgical time
Descriptive statistics paired Students t-test for beforeafter and Students t-test for independent samples between groups will be used
The objective is to determine which technique allows a greater increase in ankle range of motion in patients with equinus deformity in a safe and effective manner The results will help to establish the best surgical option for patients with gastrocnemius contracture
The study complies with ethical requirements and has the approval of the ethics committee of the Catholic University of Valencia
The minimally invasive Strayer technique is effective but carries morbidity Ultrasound-guided plantar tendon transection is a new minimally invasive technique but its effectiveness has not been well established
The aim of this study is to compare the efficacy and safety of the Strayer technique versus isolated plantar tendon transection in the surgical treatment of the equinus deformity The results will help determine the best surgical option for increasing ankle range of motion in these patients
To compare the effectiveness of the Strayer technique gastrocnemius tendon recession versus plantar tendon transection in patients with equinus deformity
Patients will be divided into two groups
Group 1 Patients with isolated gastrocnemius contracture undergoing Strayer technique This consists of ultrasound-guided recession of the gastrocnemius tendon distally
Group 2 Patients with mild contracture undergoing ultrasound-guided plantar tendon transection of the medial aspect of the gastrocnemius
The main variables will be the increase in the range of mobility of the ankle measured with a goniometer before and after surgery Pain will also be evaluated with visual analogue scale function with American Orthopaedic Foot and Ankle Society AOFAS Ankle-Hindfoot Score scale complications and surgical time
Descriptive statistics paired Students t-test for beforeafter and Students t-test for independent samples between groups will be used
The objective is to determine which technique allows a greater increase in ankle range of motion in patients with equinus deformity in a safe and effective manner The results will help to establish the best surgical option for patients with gastrocnemius contracture
The study complies with ethical requirements and has the approval of the ethics committee of the Catholic University of Valencia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None