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Efficacy and Safety of Nerve Root Axial Decompression Surgery in The Treatment of Tethered Cord Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03262844
Recruitment Status : Unknown
Verified September 2018 by Jiangang Shi, Shanghai Changzheng Hospital.
Recruitment status was:  Recruiting
First Posted : August 25, 2017
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
Jiangang Shi, Shanghai Changzheng Hospital

Brief Summary:

Background: Tethered cord syndrome (TCS) is a progressive clinical condition including a series of neurological dysfunctions and deformities attributable to abnormally increased tension on the spinal cord, which is lacking effective treatment to relieve the symptoms and prevent progression. Dr. Shi recently proposed a new technique as nerve root axial decompression surgery, which is also called capsule surgery, to treat patients with TCS. Yet, the effectiveness and safety should be further studied.

Purpose: The aim of this study is to compare the effectiveness and safety of clinical outcomes between capsule surgery and conservative treatment in patients with TCS. A study hypothesis is that outcomes will be improved after capsule surgery.

Methods: This study is a randomized clinical trial with a two-factor (2x7) research design. The TCS patients will be randomly assigned in one of the two treatment groups: capsule surgery and conservative treatment. Seven outcome measures will be collected pre-operative for baseline, and then at1, 12, 24, 48, and 96 weeks post-operative follow-up visits, including: International Consultation on Incontinence Modular Questionnaire Short Version (ICI-Q-SF), Rintala Score, a new developed Chinese version of questionnaire, Oswestry disability index (ODI), SF-12, foot function index (FFI) and Pirani score. Urodynamic testing, bladder ultrasonography, electromyogram, muscle strength and sensation of lower limbs will be obtained before and post treatment, to determine the patient's function of lower limbs. The investigator performing the outcome measures will be blinded to group assignment, and therefore will not participate in treatment. After randomization, the conservative group will be followed up in the outpatient clinic. The capsule surgery group will receive the nerve root axial decompression surgery (capsule surgery).

Data Analysis: Two 2x7 MANOVAs with repeated measures will be used to examine the differences in the seven measures between groups and at the five different time frames with the α level set at 0.05. Non-parametric tests (Mann-Whitney U tests) will be used to compare the differences in the urodynamics and muscle strength data over time and between groups.


Condition or disease Intervention/treatment Phase
Tethered Cord Syndrome Behavioral: Conservative treatment Procedure: Capsule surgery Not Applicable

Detailed Description:

Background: Tethered cord syndrome (TCS) is a progressive clinical condition including a series of neurological dysfunctions and deformities attributable to abnormally increased tension on the spinal cord. The standard surgical treatment is untethering the spinal cord and correction of the related deformity. Although reported results are encouraging, it continues to pose challenges on management of TCS patients. Symptomatic re-tethering seems to be an inevitable result, which occurs in 20%-50% patients after untethering. Recently, filum dissection was found no good to improve urinary symptoms compared to conservative treatment in teenagers as reported in an RCT study. Also, it remained controversy when to perform the surgery and how to evaluate the benefits of surgery or conservative treatment. Dr. Shi recently proposed a new technique as nerve root axial decompression surgery, which is also called capsule surgery, to treat patients with TCS. Yet, the effectiveness and safety should be further studied.

Purpose: The aim of this study is to compare the effectiveness and safety of clinical outcomes between capsule surgery and conservative treatment in patients with TCS. A study hypothesis is that outcomes will be improved after capsule surgery.

Methods: This study is a randomized clinical trial with a two-factor (2x7) research design. The TCS patients will be randomly assigned in one of the two treatment groups: capsule surgery and conservative treatment. Seven outcome measures will be collected pre-operative for baseline, and then at1, 12, 24, 48, and 96 weeks post-operative follow-up visits, including: (1) International Consultation on Incontinence Modular Questionnaire Short Version (ICI-Q-SF) to assess the urinary functions, (2) Rintala Score for bowel function, (3) a new developed Chinese version of questionnaire to assess the quality of life in patients and parents due to bladder dysfunction. (4) Oswestry disability index (ODI) to assess the function of back and lower limbs, (5)SF-12 for whole quality of life, (6) Pirani score to assess clubfoot deformity, and (7) foot function index to assess the impacts on quality of life due to clubfoot. Urodynamics, bladder ultrasonography, muscle strength and sensation of lower limbs will be obtained before and post treatment, to determine the patient's function of lower limbs. The investigator performing the outcome measures will be blinded to group assignment, and therefore will not participate in treatment. After randomization, the conservative group will be followed up in the outpatient clinic. The capsule surgery group will receive the nerve root axial decompression surgery.

Data Analysis: Two 2x7 MANOVAs with repeated measures will be used to examine the differences in the four measures between groups and at the five different time frames with the α level set at 0.05. Non-parametric tests (Mann-Whitney U tests) will be used to compare the differences in the urodynamics and muscle strength data over time and between groups.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The statistical analysist do not know the group assignment.
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Nerve Root Axial Decompression Surgery in The Treatment of Tethered Cord Syndrome: A Conservative Treatment- Controlled, Randomized, Clinical Study
Actual Study Start Date : June 16, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Conservative treatment
Conservative physiotherapy, intermittent catheterization, or drug treatment for bladder or bowel dysfunction
Behavioral: Conservative treatment
The conservative treatment group will be given diet and nursing guidance, then the drug treatment or physiotherapy will be given according to the conditions of patients. Patients with bladder dysfunction will be guided to perform routine intermittent catheterization with help of their parents.

Experimental: Capsule surgery
Nerve root axial decompression surgery (Capsule surgery)
Procedure: Capsule surgery

In the multiple segments of the spine, articular facet joint and intervertebral disc will be resected to achieve the effect of decompression.

Specific surgical segments, osteotomy range, decompression degree of each patient needs to be designed individually.





Primary Outcome Measures :
  1. Changes of patient-reported scores assessing bladder function [ Time Frame: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits. ]
    International Consultation on Incontinence Modular Questionnaire Short Version (ICI-Q-SF) is used to assess urinary function and the impacts on patient's quality of life due to urinary problems.


Secondary Outcome Measures :
  1. Changes of patient-reported scores assessing bowel function [ Time Frame: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits. ]
    Rintala Score is applied to assess bowel function and its effects on patients' quality of life.

  2. Changes of patient-reported quality of life due to bladder dysfuction [ Time Frame: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits. ]
    A new developed Chinese version of questionnaire is used to assess the quality of life in patients and parents due to bladder dysfunction.

  3. Bladder function [ Time Frame: At 1 week pre- and 1, 12, 48, and 96 weeks post-operative follow-up visits. ]
    Urodynamic testing is performed to determine the bladder function, including bladder pressure, bladder capacity, residual volume, and compliance of bladder.

  4. Muscle power [ Time Frame: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits. ]
    Muscle power is tested by manual assessment, which is classified into 6 levels.

  5. Improvment of clubfoot deformity [ Time Frame: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits. ]
    Pirani questionnaire is applied to assess the severity of clubfoot deformity by the examiner.

  6. Changes of patient-reported scores assessing foot deformity [ Time Frame: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits. ]
    Foot function index is applied to assess the impacts on patients' quality of life due to foot deformity

  7. Changes of patient-reported scores assessing function of back and lower limbs [ Time Frame: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits. ]
    Oswestry disability index (ODI) is applied to assess the function of back and lower limbs.

  8. Changes of patient-reported quality of life [ Time Frame: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits. ]
    SF-12 is applied to assess the impacts on quality of life due to tethered cord syndrome.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. patients aged 14-20 years, without gender limitation, are willing to sign informed consent;
  2. patients diagnosed with tethered cord syndrome (TCS);
  3. patients accepted untethering surgery or resection of intra-lipomas or myelomeningocele after birth;
  4. patients present with the recent occurrence of bladder or bowel dysfunction, with progressive deterioration, may be accompanied by motor deficits of lower extremity;
  5. urodynamic examination suggests neurogenic injury;
  6. the current conventional treatment is difficult to achieve satisfactory clinical outcomes.

Exclusion Criteria:

  1. bladder or ureter obstruction;
  2. other types of neurogenic bladder dysfunction (spinal cord injury, cerebral palsy, other brain injuries);
  3. anorectal malformations;
  4. poor health condition, unable to tolerate surgery;
  5. patients (or their guardians) cannot give full informed consent for cognitive dysfunction;
  6. patients who have participated in other clinical trials in the past 1 month.
  7. patients with active hepatitis B (including HBeAg) or serological markers (HBsAg or / and HBeAg or / and HBcAb), hepatitis C, tuberculosis, cytomegalovirus infection, severe fungal infection or HIV infection;
  8. patients with active peptic ulcers within 3 months before randomization.
  9. patients with malignant neoplasms

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03262844


Contacts
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Contact: Ximing Xu, MD +8618801784094 xi_mingxu@hotmail.com

Locations
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China, Shanghai
Shanghai Changzheng Hospital Recruiting
Shanghai, Shanghai, China, 200001
Contact: Ximing Xu, MD    18801784094    xi_mingxu@hotmail.com   
Sponsors and Collaborators
Shanghai Changzheng Hospital
Investigators
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Study Chair: Jiangang Shi, MD Shanghai Changzheng Hospital, Second Military Medical University
Publications:
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Responsible Party: Jiangang Shi, Chief of No.2 department of spinal surgery, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier: NCT03262844    
Other Study ID Numbers: CZ1702TCS
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neural Tube Defects
Syndrome
Disease
Pathologic Processes
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities