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Clinical Trials/NCT06260839
NCT06260839
Recruiting
N/A

Evaluation of the Effect of Percutaneous Minimally Invasive Technique Assisted by Magnetic Resonance Neurography in the Treatment of Gluteal Muscle Contracture

He Xiang1 site in 1 country44 target enrollmentFebruary 16, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Orthopedic Surgery
Sponsor
He Xiang
Enrollment
44
Locations
1
Primary Endpoint
Objective hip function scoring scale
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The goal of this clinical trial is to to compare the therapeutic effect of minimally invasive surgery guided by magnetic resonance neurography(MRN) compared with non-magnetic resonance assisted minimally invasive surgery in patients with moderate to severe gluteal muscle contracture(GMC). 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.

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 \'s 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. ).

Registry
clinicaltrials.gov
Start Date
February 16, 2024
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
He Xiang
Responsible Party
Sponsor Investigator
Principal Investigator

He Xiang

The First Affiliated Hospital of Air Force Medicial University

The First Affiliated Hospital of Air Force Medicial University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • . There is clinical or imaging evidence that there is or may be spinal or lower extremity neurological disease ;
  • . There is evidence of hip dysplasia or subluxation ;
  • .after evaluation of intolerance to surgical anesthesia ;
  • .coagulant dysfunction ;
  • . unable to complete the follow-up for various reasons ;
  • . Patients can not complete the scale assessment for other reasons

Outcomes

Primary Outcomes

Objective hip function scoring scale

Time Frame: one week after operation

The objective hip function scoring scale is a scale used to objectively evaluate the function of hip joint. The hip joint function of patients is evaluated by doctors and scored one by one according to the items. The lowest score of the scale was 0, and the highest score was 100. The higher the final score, the better the hip joint function.

Hip joint outcome score(HOS) scale

Time Frame: one week after operation

The hip joint outcome score ( HOS ) was divided into two parts : the activities-of-daily-living ( HOS-ADL ) and sports subscales( HOS-SS ).The lowest score of the scale was 0, and the highest score was 100. The higher the final score, the higher the level of daily life and motor function of hip joint.

Secondary Outcomes

  • Imaging data of patients with gluteal muscle contracture(One day before surgery and three days after surgery)
  • Measurement of intraoperative blood loss(During surgery)
  • The first ambulation time after operation(The second day after surgery)
  • Postoperative patients were satisfied with the appearance(Two weeks after the operation)
  • The occurrence of postoperative wound fat liquefaction(Two weeks after the operation)
  • Postoperative incision hematoma formation(Two weeks after the operation)
  • The record of the length of the surgical incision of the patient(During surgery)
  • Hip joint function of patients(One day before surgery and three days after surgery)
  • Record the duration of the patient 's surgery(During surgery)
  • postoperative pain score(One day after surgery)
  • The record of postoperative wound infection(Two weeks after the operation)
  • Postoperative wound peripheral nerve vascular injury(Two weeks after the operation)

Study Sites (1)

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