Percutaneous HydroDiscectomy Compared to TESI for Radiculopathy

• Sponsor: Montefiore Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02414698
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Arms: 2
• Duration (Months): 1.9
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lumbar Herniated Disc	Procedure: Percutaneous Hydrodiscectomy; Drug: TESI	Phase 4

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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)
• Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Percutaneous Hydrodiscectomy Percutaneous Hydrodiscectomy with the SpineJet Hydrodiscectomy System	Procedure: Percutaneous Hydrodiscectomy; The HydroD uses a thin supersonic stream of water to cut, ablation, remove disc material percutaneously via a skin puncture.
Active Comparator: TESI Transforaminal Epidural Steroid Injections	Drug: TESI; Transforaminal epidural steroid injections given in the lumbar spine.; Other Names: Transforaminal epidural steroid injections

Outcome Measures

Primary Outcome Measures

1. Number of Patients in Each Group That Experience at Least a 50% Reduction in Leg and Back Pain [6 months]

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

Secondary Outcome Measures

1. Change From Baseline Oswestry Disability Index (ODI) [24 months]

2. Change From Baseline ED-5Q Questionnaire [24 months]

Other Outcome Measures

1. Global Improvement Impression of Change (PGIC) [24 months]

   Patient self assessment of the Global Improvement Impression of Change (PGIC)

2. Independent Physician Assessment (McNab Criteria) [24 months]

3. Adverse Events [24 months]

   Procedure and device related adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montefiore Medical Center	Bronx	New York	United States	10467

Sponsors and Collaborators

• Montefiore Medical Center

Investigators

• Principal Investigator: Sayed E Wahezi, MD, Montefiore Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Montefiore Medical Center
• ClinicalTrials.gov Identifier: NCT02414698
• Other Study ID Numbers: 2014-3750
• First Posted: Apr 13, 2015
• Last Update Posted: Mar 2, 2020
• Last Verified: Feb 1, 2020

• Additional relevant MeSH terms: Intervertebral Disc Displacement; Radiculopathy

Study Results

Participant Flow

Arm/Group Title	Percutaneous Hydrodiscectomy	TESI
Arm/Group Description	Percutaneous Hydrodiscectomy with the SpineJet Hydrodiscectomy System Percutaneous Hydrodiscectomy: The HydroD uses a thin supersonic stream of water to cut, ablation, remove disc material percutaneously via a skin puncture.	Transforaminal Epidural Steroid Injections TESI: Transforaminal epidural steroid injections given in the lumbar spine.
Period Title: Overall Study
STARTED	3	1
COMPLETED	3	1
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Percutaneous Hydrodiscectomy	TESI	Total
Arm/Group Description	Percutaneous Hydrodiscectomy with the SpineJet Hydrodiscectomy System Percutaneous Hydrodiscectomy: The HydroD uses a thin supersonic stream of water to cut, ablation, remove disc material percutaneously via a skin puncture.	Transforaminal Epidural Steroid Injections TESI: Transforaminal epidural steroid injections given in the lumbar spine.	Total of all reporting groups
Overall Participants	3	1	4
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	3 100%	1 100%	4 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45 (5)	45 (0)	45 (5)
Sex: Female, Male (Count of Participants)
Female	2 66.7%	1 100%	3 75%
Male	1 33.3%	0 0%	1 25%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
United States	3 100%	1 100%	4 100%

Outcome Measures

1. Primary Outcome

Title	Number of Patients in Each Group That Experience at Least a 50% Reduction in Leg and Back Pain
Description	Pain improvement in all patients in HydroD arm with at least 50% reduction in leg and back pain.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Data were not collected.

Arm/Group Title	Percutaneous Hydrodiscectomy	TESI
Arm/Group Description	Percutaneous Hydrodiscectomy with the SpineJet Hydrodiscectomy System Percutaneous Hydrodiscectomy: The HydroD uses a thin supersonic stream of water to cut, ablation, remove disc material percutaneously via a skin puncture.	Transforaminal Epidural Steroid Injections TESI: Transforaminal epidural steroid injections given in the lumbar spine.
Measure Participants	0	0

2. Secondary Outcome

Title	Change From Baseline Oswestry Disability Index (ODI)
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	Percutaneous Hydrodiscectomy	TESI
Arm/Group Description	Percutaneous Hydrodiscectomy with the SpineJet Hydrodiscectomy System Percutaneous Hydrodiscectomy: The HydroD uses a thin supersonic stream of water to cut, ablation, remove disc material percutaneously via a skin puncture.	Transforaminal Epidural Steroid Injections TESI: Transforaminal epidural steroid injections given in the lumbar spine.
Measure Participants	0	0

3. Secondary Outcome

Title	Change From Baseline ED-5Q Questionnaire
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	Percutaneous Hydrodiscectomy	TESI
Arm/Group Description	Percutaneous Hydrodiscectomy with the SpineJet Hydrodiscectomy System Percutaneous Hydrodiscectomy: The HydroD uses a thin supersonic stream of water to cut, ablation, remove disc material percutaneously via a skin puncture.	Transforaminal Epidural Steroid Injections TESI: Transforaminal epidural steroid injections given in the lumbar spine.
Measure Participants	0	0

4. Other Pre-specified Outcome

Title	Global Improvement Impression of Change (PGIC)
Description	Patient self assessment of the Global Improvement Impression of Change (PGIC)
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Other Pre-specified Outcome

Title	Independent Physician Assessment (McNab Criteria)
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Other Pre-specified Outcome

Title	Adverse Events
Description	Procedure and device related adverse events
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Percutaneous Hydrodiscectomy		TESI
Arm/Group Description	Percutaneous Hydrodiscectomy with the SpineJet Hydrodiscectomy System Percutaneous Hydrodiscectomy: The HydroD uses a thin supersonic stream of water to cut, ablation, remove disc material percutaneously via a skin puncture.		Transforaminal Epidural Steroid Injections TESI: Transforaminal epidural steroid injections given in the lumbar spine.
All Cause Mortality
	Percutaneous Hydrodiscectomy		TESI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/1 (0%)
Serious Adverse Events
	Percutaneous Hydrodiscectomy		TESI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	Percutaneous Hydrodiscectomy		TESI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/1 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.