Orthopedic SurgeryNCT06260839
the Effect of Minimally Invasive Technique Assisted by Magnetic Resonance Neurography
A study testing magnetic resonance neurography and no magnetic resonance neurography in people with Orthopedic Surgery, run by He Xiang at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Orthopedic Surgery
- What is being tested?
- magnetic resonance neurography and no magnetic resonance neurography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 16 Feb 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- （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
Who cannot join
- . 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital, the Fourth Military Medical University
Xi'an, Shaanxi, 710032
Xiang He, MS, 8684771013, caruya@163.com
Long Bi, Prof., 8684771013, bilong@fmmu.edu.cn
About this study
Official title: 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.
Read the 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. ).
- Conditions
- Orthopedic Surgery
- Being tested
- magnetic resonance neurography, no magnetic resonance neurography
- Keywords
- gluteal muscle contracture, Minimally invasive release surgery, Magnetic resonance neurography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance neurographyProcedure or surgery
preoperative magnetic resonance neurography and assisted design of surgical approach
no magnetic resonance neurographyProcedure or surgery
Preoperative magnetic resonance neurography was not performed, and general minimally invasive surgery was performed
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: no magnetic resonance neurography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: one week after operation
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Two weeks after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start16 Feb 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthopedic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- He Xiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, He Xiang, The First Affiliated Hospital of Air Force Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260839
- Sponsor's protocol ID
- KY20232442-F-1
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Considering the protection of patient privacy, we do not consider the disclosure of research data.
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.
PubMed 21127436
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Percutaneous Minimally Invasive Technique Assisted by Magnetic Resonance Neurography in the Treatment of Gluteal Muscle Contracture
- ClinicalTrials.gov ID
- NCT06260839
- Acronym / sponsor ID
- KY20232442-F-1
- Conditions
- Orthopedic Surgery
- Keywords
- gluteal muscle contracture, Minimally invasive release surgery, Magnetic resonance neurography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- He XiangUniversity, hospital or other
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. ).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRN guided minimally invasive surgery group | Experimental | Procedure: magnetic resonance neurographyThe 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. |
| Minimally invasive surgery group | Active comparator | Procedure: no magnetic resonance neurographyIn 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- （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
Key exclusion criteria (6 listed)
- . 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 ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnetic resonance neurographypreoperative magnetic resonance neurography and assisted design of surgical approach | Procedure or surgery | MRN guided minimally invasive surgery group |
| no magnetic resonance neurographyPreoperative magnetic resonance neurography was not performed, and general minimally invasive surgery was performed | Procedure or surgery | Minimally invasive surgery group |
Primary outcome
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.
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.
12 secondary outcomes
Hip joint function of patients
Time frame: One day before surgery and three days after surgery
Imaging data of patients with gluteal muscle contracture
Time frame: One day before surgery and three days after surgery
Record the duration of the patient 's surgery
Time frame: During surgery
The record of the length of the surgical incision of the patient
Time frame: During surgery
Measurement of intraoperative blood loss
Time frame: During surgery
The first ambulation time after operation
Time frame: The second day after surgery
postoperative pain score
Time frame: One day after surgery
Postoperative patients were satisfied with the appearance
Time frame: Two weeks after the operation
The record of postoperative wound infection
Time frame: Two weeks after the operation
The occurrence of postoperative wound fat liquefaction
Time frame: Two weeks after the operation
Postoperative wound peripheral nerve vascular injury
Time frame: Two weeks after the operation
Postoperative incision hematoma formation
Time frame: Two weeks after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Results publication: PubMed 21127436Liu 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.
- Individual participant dataSharing planned: No. Considering the protection of patient privacy, we do not consider the disclosure of research data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnetic resonance neurography and no magnetic resonance neurography in people with Orthopedic Surgery, run by He Xiang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiang He, MS (8684771013, caruya@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hip joint outcome score(HOS) scale (time frame: one week after operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06260839, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.