Percutaneous HydroDiscectomy Compared to TESI for Radiculopathy

NCT02414698 | Terminated Phase 4 Results

• 1 other identifier: 2014-3750
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the outcomes of percutaneous lumbar Hydrodiscectomy (HydroD) with the SpineJet Hydrodiscectomy System to transforaminal epidural steroid injections (TESI) in patients with lumbar radiculopathy due to contained disc herniation with symptoms that persist following a treatment course of conservative management including physical therapy and anti-inflammatory medication.

Conditions

Lumbar Herniated Disc

Outcome Measures

Primary Outcomes (1)

• Number of Patients in Each Group That Experience at Least a 50% Reduction in Leg and Back Pain

  Pain improvement in all patients in HydroD arm with at least 50% reduction in leg and back pain.

  6 months

Secondary Outcomes (2)

• Change From Baseline Oswestry Disability Index (ODI)

  24 months

• Change From Baseline ED-5Q Questionnaire

  24 months

Other Outcomes (3)

• Global Improvement Impression of Change (PGIC)

  24 months

• Independent Physician Assessment (McNab Criteria)

  24 months

• Adverse Events

  24 months

Study Arms (2)

Percutaneous Hydrodiscectomy

ACTIVE COMPARATOR

Percutaneous Hydrodiscectomy with the SpineJet Hydrodiscectomy System

Procedure: Percutaneous Hydrodiscectomy

TESI

ACTIVE COMPARATOR

Transforaminal Epidural Steroid Injections

Drug: TESI

Interventions

Percutaneous Hydrodiscectomy PROCEDURE

The HydroD uses a thin supersonic stream of water to cut, ablation, remove disc material percutaneously via a skin puncture.

Percutaneous Hydrodiscectomy

TESI DRUG

Transforaminal epidural steroid injections given in the lumbar spine.

Also known as: Transforaminal epidural steroid injections

TESI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Single level subligamentous lumbar disc herniation with a size of up to 1/3 of the spinal canal sagittal diameter, with unilateral radicular pain attributed to nerve root impingement from lumbar disc material correlated with MRI or CT findings
• Axial MRI demonstrating unilateral focal contained disc herniation with single nerve contact
• Patient failed at least 3 weeks of conservative management within a 6 month period including anti-inflammatory medication and physical therapy
• Patient has not had previous epidural steroid injections at the affected lumbar level within 3 months of presenting for the study
• Patient is a candidate for transforaminal epidural steroid injections
• Positive Straight Leg Raising (SLR) test
• Patient has a leg pain \> back pain
• The subject is physically and mentally able to participate in the study
• Patient is willing and able to provide informed consent
• Patient is willing and able to comply with the study protocol

You may not qualify if:

• Patient has had surgery at the affected level
• Extruded or sequestered disc herniation
• Free fragment herniation
• Discogenic pain without nerve root compression
• Previous surgery at the involved lumbar level
• Segmental instability (motion on flexion/extension films)
• Spondylolisthesis \> Grade 2
• Severe central canal stenosis or bony impingement at the index level
• Significant loss of disc height (\> 60%) compared with the adjacent higher level or disc height \< 6mm at affected level
• Motor deficit (strength rating less than 4/5 in the lower extremity test)
• Positive Waddell test (\> 3 of 5 tests)
• Active local or systemic infection
• Actively in litigation for pain symptoms
• Currently on Workman's Compensation
• Women who are pregnant

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Sayed E Wahezi, MD
• Organization: Montefiore Medical Center

swahezi@montefiore.org

7189207246

Study Officials

• Sayed E Wahezi, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: April 13, 2015
• Study Start: January 1, 2015
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 2, 2020
• Results First Posted: February 12, 2020

Record last verified: 2020-02

Locations

US (1)