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

NCT03262844 | Unknown

• 1 other identifier: CZ1702TCS
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Tethered Cord Syndrome

Outcome Measures

Primary Outcomes (1)

• Changes of patient-reported scores assessing bladder function

  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.

  At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.

Secondary Outcomes (8)

• Changes of patient-reported scores assessing bowel function

  At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.

• Changes of patient-reported quality of life due to bladder dysfuction

  At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.

• Bladder function

  At 1 week pre- and 1, 12, 48, and 96 weeks post-operative follow-up visits.

• Muscle power

  At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.

• Improvment of clubfoot deformity

  At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.

Study Arms (2)

Conservative treatment

PLACEBO COMPARATOR

Conservative physiotherapy, intermittent catheterization, or drug treatment for bladder or bowel dysfunction

Behavioral: Conservative treatment

Capsule surgery

EXPERIMENTAL

Nerve root axial decompression surgery (Capsule surgery)

Procedure: Capsule surgery

Interventions

Conservative treatment BEHAVIORAL

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.

Conservative treatment

Capsule surgery PROCEDURE

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.

Capsule surgery

Eligibility Criteria

• Age: 14 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• bladder or ureter obstruction;
• other types of neurogenic bladder dysfunction (spinal cord injury, cerebral palsy, other brain injuries);
• anorectal malformations;
• poor health condition, unable to tolerate surgery;
• patients (or their guardians) cannot give full informed consent for cognitive dysfunction;
• patients who have participated in other clinical trials in the past 1 month.
• 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;
• patients with active peptic ulcers within 3 months before randomization.
• patients with malignant neoplasms

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200001, China

RECRUITING

Related Publications (1)

• Steinbok P, MacNeily AE, Hengel AR, Afshar K, Landgraf JM, Hader W, Pugh J. Filum Section for Urinary Incontinence in Children with Occult Tethered Cord Syndrome: A Randomized, Controlled Pilot Study. J Urol. 2016 Apr;195(4 Pt 2):1183-8. doi: 10.1016/j.juro.2015.09.082. Epub 2016 Feb 28.

  PMID: 26926544 BACKGROUND

MeSH Terms

Conditions

Neural Tube Defects

Interventions

Conservative Treatment; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jiangang Shi, MD

  Shanghai Changzheng Hospital, Second Military Medical University

  STUDY CHAIR

Central Study Contacts

Ximing Xu, MD

CONTACT

+8618801784094; xi_mingxu@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistical analysist do not know the group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of No.2 department of spinal surgery

Study Record Dates

• First Submitted: August 6, 2017
• First Posted: August 25, 2017
• Study Start: June 16, 2017
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2020
• Last Updated: September 27, 2018

Record last verified: 2018-09

Locations

CN (1)