the Effect of Minimally Invasive Technique Assisted by Magnetic Resonance Neurography

NCT06260839 | Recruiting

• 1 other identifier: KY20232442-F-1
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthopedic Surgery

Keywords

gluteal muscle contracture; Minimally invasive release surgery; Magnetic resonance neurography

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Hip joint function of patients

  One day before surgery and three days after surgery

• Imaging data of patients with gluteal muscle contracture

  One day before surgery and three days after surgery

• Record the duration of the patient 's surgery

  During surgery

• The record of the length of the surgical incision of the patient

  During surgery

• Measurement of intraoperative blood loss

  During surgery

Other Outcomes (2)

• Gluteal muscle contracture severity ZHAO 's classification

  one day before surgery

• Demographic characteristics of patients

  one day before surgery

Study Arms (2)

MRN guided minimally invasive surgery group

EXPERIMENTAL

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

Minimally invasive surgery group

ACTIVE COMPARATOR

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

Interventions

magnetic resonance neurography PROCEDURE

preoperative magnetic resonance neurography and assisted design of surgical approach

MRN guided minimally invasive surgery group

no magnetic resonance neurography PROCEDURE

Preoperative magnetic resonance neurography was not performed, and general minimally invasive surgery was performed

Minimally invasive surgery group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• （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

You may not qualify if:

• 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

Sponsors & Collaborators

• He Xiang: lead

Study Sites (1)

Xijing Hospital, the Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 21127436 RESULT

Central Study Contacts

Xiang He, MS

CONTACT

8684771013; caruya@163.com

Long Bi, Prof.

CONTACT

8684771013; bilong@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The First Affiliated Hospital of Air Force Medicial University

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 15, 2024
• Study Start: February 16, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)