Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06260839
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2024-01-30
Brief Title:
the Effect of Minimally Invasive Technique Assisted by Magnetic Resonance Neurography
Sponsor:
He Xiang
Organization:
The First Affiliated Hospital of Air Force Medicial University
Study Overview
Official Title:
Evaluation of the Effect of Percutaneous Minimally Invasive Technique Assisted by Magnetic Resonance Neurography in the Treatment of Gluteal Muscle Contracture
Status:
RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
The goal of this clinical trial is to to compare the therapeutic effect of minimally invasive surgery guided by magnetic resonance neurographyMRN compared with non-magnetic resonance assisted minimally invasive surgery in patients with moderate to severe gluteal muscle contractureGMC The main question it aims to answer are magnetic resonance neurography can better help optimize the surgical path of minimally invasive surgery in the treatment of gluteal muscle contracture
Participants will underwent preoperative magnetic resonance examination according to different groups and then the experimental group designed individualized surgical approach and MRN-assisted minimally invasive release according to the imaging findings In the control group preoperative magnetic resonance examination was only used to assist in the diagnosis and evaluation of gluteal muscle contracture and the magnetic resonance results were not used to assist in the design of surgical approach In the control group non-MRN-assisted minimally invasive release was performed The researchers will compare the intraoperative surgery-related indicators and postoperative hip function scores and complications of patients in different groups to see if magnetic resonance-assisted surgery has a better postoperative effect
Participants will underwent preoperative magnetic resonance examination according to different groups and then the experimental group designed individualized surgical approach and MRN-assisted minimally invasive release according to the imaging findings In the control group preoperative magnetic resonance examination was only used to assist in the diagnosis and evaluation of gluteal muscle contracture and the magnetic resonance results were not used to assist in the design of surgical approach In the control group non-MRN-assisted minimally invasive release was performed The researchers will compare the intraoperative surgery-related indicators and postoperative hip function scores and complications of patients in different groups to see if magnetic resonance-assisted surgery has a better postoperative effect
Detailed Description:
According to the different surgical intervention methods the cases finally included in the study were divided into minimally invasive surgery group and MRN-guided minimally invasive surgery group according to the randomization method It is expected that the number of cases finally included in the study in both groups will be 22 cases
Firstly the age and sex of the two groups of patients included in the study were recorded respectively and the moderate and severe classification was carried out according to the Zhao 39s classification system The experimental group and the control group were examined by pelvic X-ray magnetic resonance and ultrasound before operation After improving the relevant preoperative examination and excluding surgical contraindications the intervention measures of the experimental group were to analyze the relationship between the shape of the contracture zone the distance between the sciatic nerve and the contracture zone and the external rotation angle according to the preoperative MRN manifestations of the patients and to design the individualized surgical approach according to the imaging manifestations MRN-assisted minimally invasive release in the control group preoperative magnetic resonance imaging was only used to assist in the diagnosis and evaluation of gluteal muscle contracture and the results of magnetic resonance imaging were not used to assist in the design of surgical approach In the control group non-MRN-assisted minimally invasive release was performed For patients they all underwent magnetic resonance imaging before surgery and all underwent minimally invasive surgery However the design process of the specific surgical approach is not clear so it is a single-blind design for patients All the operations were completed by two senior doctors of our research group The data of postoperative follow-up were recorded and the conclusion was drawn by statistical analysis
Intraoperative research indicators include incision length operation duration intraoperative blood loss first time to get out of bed pain score etc
Postoperative follow-up study indicators included subjective and objective functional rating scales hip flexion and adduction activity leg squat cross-leg test Ober sign pain in activity claudication in walking patient appearance satisfaction complications wound infection fat liquefaction neurovascular injury incision hematoma formation etc
Firstly the age and sex of the two groups of patients included in the study were recorded respectively and the moderate and severe classification was carried out according to the Zhao 39s classification system The experimental group and the control group were examined by pelvic X-ray magnetic resonance and ultrasound before operation After improving the relevant preoperative examination and excluding surgical contraindications the intervention measures of the experimental group were to analyze the relationship between the shape of the contracture zone the distance between the sciatic nerve and the contracture zone and the external rotation angle according to the preoperative MRN manifestations of the patients and to design the individualized surgical approach according to the imaging manifestations MRN-assisted minimally invasive release in the control group preoperative magnetic resonance imaging was only used to assist in the diagnosis and evaluation of gluteal muscle contracture and the results of magnetic resonance imaging were not used to assist in the design of surgical approach In the control group non-MRN-assisted minimally invasive release was performed For patients they all underwent magnetic resonance imaging before surgery and all underwent minimally invasive surgery However the design process of the specific surgical approach is not clear so it is a single-blind design for patients All the operations were completed by two senior doctors of our research group The data of postoperative follow-up were recorded and the conclusion was drawn by statistical analysis
Intraoperative research indicators include incision length operation duration intraoperative blood loss first time to get out of bed pain score etc
Postoperative follow-up study indicators included subjective and objective functional rating scales hip flexion and adduction activity leg squat cross-leg test Ober sign pain in activity claudication in walking patient appearance satisfaction complications wound infection fat liquefaction neurovascular injury incision hematoma formation etc
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