Percutaneous HydroDiscectomy Compared to TESI for Radiculopathy

Lumbar Herniated Disc Clinical Trial

Official title:

Single Center, Randomized PROspective Study Comparing Percutaneous HydroDiscectomy to Transforaminal Epidural Steroid Injections in the Treatment Of Radiculopathy Secondary to Lumbar Disc Herniation (PROPHESOR)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02414698
• Other study ID #: 2014-3750
• Status: Terminated
• Phase: Phase 4
• Start date: January 2015
• Est. completion date: March 2015

Study information

• Verified date: February 2020
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Lumbar disc herniation is one of the leading causes of lower back pain and sciatica. If conservative management fails to relieve radiculopathy secondary to lumbar disc herniation, interventional treatments such as epidural steroid injections are indicated. Patients that do not have pain relief from transforaminal epidural steroid injections or over time relief is diminished, surgical intervention is typically recommended and microdiscectomy is the surgical intervention of choice. Over the years, a number of minimally invasive techniques for lumbar disc herniation have been introduced including percutaneous mechanical lumbar discectomy, including percutaneous hydrodiscectomy (HydroD).

The purpose of this study is to compare the outcomes of HydroD with the SpineJet Hydrodiscectomy System to transforaminal epidural steroid injections (TESI) in patients with lumbar radiculopathy due to contained disc herniation that have failed a course of conservative management including anti-inflammatory medication and physical therapy. Patients will be randomized in a 1:1 ratio to Percutaneous Hydrodiscectomy or Transforaminal Epidural Steroid Injections.

Patients randomized to the TESI group that fail to have >50% relief of pain after two courses of TESI injections spaced two weeks apart within 2 months of the procedure, will be provided with the option to cross-over to the HydroD group after which they will follow the same follow-up visits. If after cross-over into the HydroD group they fail to have >50% relief of pain after the initial intervention within 2 months of the procedure, they will be referred for surgery and their participation in the study will end.

Patients randomized to the HydroD group that fail to have >50% relief of pain after the initial procedure, or within 2 months of the procedure, will be provided with the option to cross-over to the TESI group. If after cross-over to the TESI group they fail to have >50% relief of pain after two courses of TESI injections spaced two weeks apart within 2 months of the procedure, they will be referred for surgery and will no longer be followed in the study.

Patients will be followed at 1, and 4, and 2, 6, 12, and 24 months post-procedure. Outcomes assessments include NRS for pain, ODI, neurological and independent physician evaluations.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Lumbar Herniated Disc
• Radiculopathy

Intervention

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

Drug:
• TESI
Transforaminal epidural steroid injections given in the lumbar spine.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Global Improvement Impression of Change (PGIC)	Patient self assessment of the Global Improvement Impression of Change (PGIC)	24 months
Other	Independent Physician Assessment (McNab Criteria)		24 months
Other	Adverse Events	Procedure and device related adverse events	24 months
Primary	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	Change From Baseline Oswestry Disability Index (ODI)		24 months
Secondary	Change From Baseline ED-5Q Questionnaire		24 months