the Effect of Minimally Invasive Technique Assisted by Magnetic Resonance Neurography

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

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.

Study Overview

• Status: Recruiting
• Conditions: Orthopedic Surgery
• Intervention / Treatment: Procedure: magnetic resonance neurography; Procedure: no magnetic resonance neurography

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. ).

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiang He, MS; Phone Number: 8684771013; Email: caruya@163.com
• Study Contact Backup: Name: Long Bi, Prof.; Phone Number: 8684771013; Email: bilong@fmmu.edu.cn

Study Locations

• China
  • Shaanxi
    • Xian, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital, the Fourth Military Medical University
      • Contact: Xiang He, MS; Phone Number: 8684771013; Email: caruya@163.com
      • Contact: Long Bi, Prof.; Phone Number: 8684771013; Email: bilong@fmmu.edu.cn
      • Principal Investigator: Long Bi, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria：

（1). Meet the clinical and imaging diagnostic criteria of GMC ; (2).According to Zhao 's classification system, patients with moderate to severe GMC diagnosed by medical history, symptoms and physical examination ; (3).Conservative treatment is ineffective for at least 6 months, and daily life is significantly affected ; (4).willing to be hospitalized and receive minimally invasive surgery ; (5). Can cooperate to complete the follow-up ; (6).Patients or immediate family members signed informed consent ; (7). Age 18-65 years old

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MRN guided minimally invasive surgery group; The intervention measures of the experimental group were to analyze the relationship between the shape of the contracture band, the distance between the sciatic nerve and the contracture band, 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 and perform MRN-assisted minimally invasive release.	Procedure: magnetic resonance neurography; preoperative magnetic resonance neurography and assisted design of surgical approach
Active Comparator: Minimally invasive surgery group; 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	Procedure: no magnetic resonance neurography; Preoperative magnetic resonance neurography was not performed, and general minimally invasive surgery was performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hip joint outcome score(HOS) scale	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.	one week after operation
Objective hip function scoring scale	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.	one week after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hip joint function of patients	The patient 's hip function is mainly evaluated by the physician during physical examination. The main indicators include hip flexion and adduction activity, and leg squat, cross-legged test, Ober sign, activity with or without pain, walking with or without claudication.	One day before surgery and three days after surgery
Imaging data of patients with gluteal muscle contracture	The imaging data of the patients included the presence or absence of gluteus maximus atrophy, the cumulative range of the contracture zone, the characteristics of the course, and the presence or absence of connection with the iliotibial tract ; the distance between the contracture belt and the sciatic nerve ; external rotation angle of femur.	One day before surgery and three days after surgery
Record the duration of the patient 's surgery	Through the operation record, nursing record and the actual situation of the operation, the operation duration of the patients was recorded. The longer the operation duration, the greater the operation risk.	During surgery
The record of the length of the surgical incision of the patient	Through the patient 's surgical records and intraoperative actual situation, record the patient 's intraoperative incision length. The greater the length of the incision, the greater the risk of surgery.	During surgery
Measurement of intraoperative blood loss	The patient 's intraoperative blood loss was recorded through the patient 's anesthesia records, nursing records, and actual intraoperative conditions. The higher the amount of bleeding, the greater the risk of surgery.	During surgery
The first ambulation time after operation	The time when the patient can get out of bed for the first time after surgery, the earlier the time, the smaller the side effects of the patient 's surgery on the patient.	The second day after surgery
postoperative pain score	The postoperative pain score of the patient was evaluated by the anesthesiologist. The postoperative pain score of the patient was evaluated by the postoperative anesthesia follow-up record in the medical record system. Minimum 0 points, maximum 100 points. The lower the score, the smaller the surgical trauma.	One day after surgery
Postoperative patients were satisfied with the appearance	The patient 's satisfaction with the operation was evaluated by the form of scale score. Minimum 0 points, maximum 100 points. The higher the score, the more satisfied the patient is with the operation.	Two weeks after the operation
The record of postoperative wound infection	The record of postoperative wound infection is mainly recorded by the doctor during the postoperative follow-up. The occurrence of infection is a side effect of the operation.	Two weeks after the operation
The occurrence of postoperative wound fat liquefaction	Postoperative wound fat liquefaction was mainly recorded by the doctor during postoperative follow-up. The occurrence of wound fat liquefaction was a side effect of surgery.	Two weeks after the operation
Postoperative wound peripheral nerve vascular injury	The records of postoperative nerve injury were mainly recorded by doctors during postoperative follow-up. The occurrence of nerve injury is a side effect of surgery.	Two weeks after the operation
Postoperative incision hematoma formation	The record of incision hematoma formation after operation is mainly recorded by doctors during postoperative follow-up. The occurrence of incision hematoma formation is a side effect of operation.	Two weeks after the operation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gluteal muscle contracture severity ZHAO 's classification	The ZHAO 's grading is evaluated by the physician according to the ZHAO 's grading scale. The lowest level of the scale is grade 1, and the highest level is grade 3. The higher the level, the more serious the gluteal muscle contracture is.	one day before surgery
Demographic characteristics of patients	Demographic characteristics of patients	one day before surgery

Collaborators and Investigators

• Sponsor: He Xiang

Publications and helpful links

General Publications

• Liu GH, Cao FQ, Yang SH, Zhu JF. Factors influencing the treatment of severe gluteal muscle contracture in children. J Pediatr Orthop B. 2011 Mar;20(2):67-9. doi: 10.1097/BPB.0b013e328341bcb2.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Magnetic resonance neurography; gluteal muscle contracture; Minimally invasive release surgery
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Contracture
• Other Study ID Numbers: KY20232442-F-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Considering the protection of patient privacy, we do not consider the disclosure of research data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No