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A Prospective, Randomized, Multicenter Study to Demonstrate the Superiority of the Barricaid to Discectomy for Primary Lumbar Disc Herniation

Primary Purpose

Lumbar Disc Herniation

Status
Active
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Barricaid
Standard of Care
Sponsored by
Intrinsic Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 21 to 75 years old and skeletally mature (male or female).
  • Patients with posterior or posterolateral disc herniations at one level between L1 and S1 with radiographic confirmation of neural compression using Magnetic Resonance Imaging (MRI).
  • At least six (6) weeks of failed, conservative treatment prior to surgery
  • Oswestry Disability Index (ODI) Questionnaire score of at least 40/100 at baseline.
  • Visual Analog Scale (VAS) leg pain (one or both legs) of at least 40/100 at baseline.
  • Psychosocially, mentally and physically able to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.

Exclusion Criteria:

  • Spondylolisthesis Grade II or higher (25% slip or greater).
  • Prior surgery at the index lumbar vertebral level.
  • Subject has scoliosis of greater than ten (10) degrees (both angular and rotational).
  • Any metabolic bone disease.
  • Subject has insulin-dependent diabetes mellitus.
  • Subject has been diagnosed with active hepatitis, acquired immunodeficiency syndrome (AIDS), or Human immunodeficiency virus (HIV).
  • Subject has been diagnosed with rheumatoid arthritis or other autoimmune disease.
  • Subject has a known allergy to titanium, polyethylene or polyester materials.
  • Any subject that cannot have a baseline MRI taken.
  • Subject is pregnant or interested in becoming pregnant in the next three (3) years.
  • Subject has active tuberculosis or has had tuberculosis in the past three (3) years.
  • Subject is currently involved in another investigational study.
  • Any contraindication for MRI or Computed tomography CT scan (e.g. claustrophobia, contrast allergy).

Sites / Locations

  • LKH Graz
  • Medizinische Universität Innsbruck
  • OLV Aalst
  • ZNA Middleheim / AZ Klina
  • AZ Nikolaas
  • CHRU Lille, Hôpital Roger Salengro
  • Orthopädische Klinik und Poliklinik - Universitätsmedizin Rostock
  • Neurochirurgische Universitätsklinik Knappschafts-Krankenhaus Bochum-Langendreer
  • Klinikum Augsburg
  • Charité - Universitätsmedizin Berlin
  • Klinikum Deggendorf
  • Universitätsklinikum Düsseldorf
  • Asklepios Westklinikum Hamburg
  • UNI Kiel
  • St. Bonifatius Hospital GmbH
  • UMM Mannheim
  • SLAZ Amsterdam
  • MCH Westeinde
  • MCH Antoniushove
  • Isala Klinieken
  • KSA Aarau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Barricaid Device

Standard of Care

Arm Description

Intervention: Barricaid Device

Standard (Limited) Discectomy Only

Outcomes

Primary Outcome Measures

Combined success of multiple clinical outcomes, including Oswestry disability index, Visual Analog Scale (VAS), and multiple radiographically confirmed measures
To be considered a success, a patient will have achieved success in each of the following outcomes: 15 point (out of 100 point scale) improvement in Oswestry compared to pre-op 20 point (on a 100 point scale) improvement in VAS Leg (based on the primary leg complaint; if both legs have a minimum of 40/100 pre-operatively, the average leg score will be used) Maintenance of average disc height (75% or greater of preoperative disc height) compared to pre-op No deterioration of neurological status at the index level measured by motor function Device integrity and lack of implant migration (radiographic, implanted patients only) No radiographically confirmed spontaneous fusion No radiographically or surgically confirmed reherniation at the index level (on either side) No secondary surgical interventions at the index level
No radiographic evidence of recurrent disc herniation
To be considered a success, a patient will have no evidence of recurrent disc herniation at the index level at any time up to and including the 24-month follow-up. Recurrent herniation may be confirmed surgically, or radiographically as determined by an independent review (unless surgically confirmed that the suspected herniation is not a herniation, e.g. scar tissue or residual nucleus material).

Secondary Outcome Measures

Visual Analog Scale (VAS) Back Pain Improvement
Change in back pain as measured using a Visual Analog Scale (VAS), on a scale of 0-100, with lower values representing better outcome. A subject is a success if there is at least a 20 point improvement on the VAS back at 24 months, relative to baseline.
Oswestry Disability Index (ODI) Improvement
Change in function as measured using the Oswestry Disability Index (ODI). The ODI is scored on a scale from 0% to 100%, with higher scores indicating higher levels of disability. A subject is a success if there is at least a 15 point improvement (decrease) in the ODI at the 24 month visit relative to baseline.
Reoperation
A subject will be deemed a success if they have not had a second operation at the index level by the 24 month visit. Rates of subject success in treatment and control will be compared at 24 months. A subject is a success if there is at least 75% of the pre-op disc height preserved at the 24 month visit.
Visual Analog Scale (VAS) LEG Pain Improvement
Change in leg pain as measured using a Visual Analog Scale (VAS), on a scale of 0-100, with lower values representing better outcome. A subject is a success if there is at least a 20 point improvement on VAS leg pain in the ipsilateral leg at 24 months, relative to baseline.
Disc Height Maintenance
A subject is a success if there is at least 75% of the pre-op disc height preserved as measured on MRI, at the 24 month visit.

Full Information

First Posted
January 6, 2011
Last Updated
September 27, 2023
Sponsor
Intrinsic Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01283438
Brief Title
A Prospective, Randomized, Multicenter Study to Demonstrate the Superiority of the Barricaid to Discectomy for Primary Lumbar Disc Herniation
Official Title
A Prospective, Randomized, Multicenter Study to Demonstrate the Superiority of the Barricaid® to Discectomy for Primary Lumbar Disc Herniation: Extended Follow-Up of the Barricaid® Annular Closure Device (ACD) Randomized Control Trial (RCT) Postmarket Cohort for Lumbar Disc Herniation and Interaction With Other Risk Factors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 17, 2010 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intrinsic Therapeutics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A randomized study to demonstrate the superiority of the Barricaid® when used in conjunction with limited discectomy, compared to limited discectomy alone, with regard to preventing reherniation and the recurrence of pain or dysfunction.
Detailed Description
The Barricaid is indicated for patients with radiculopathy (with or without back pain), a positive Straight Leg Raise (L45, L5S1) or femoral stretch test (L12, L23, L34), and a posterior or posterolateral herniation at one level between L1 and S1 with radiographic confirmation of neural compression using MRI who are found to have an annular defect (post discectomy) which measures between 4mm and 6mm tall and between 6mm and 10mm wide, have a minimum posterior disc height of 5mm, and have failed at least 6 weeks of conservative treatment including a post-approval amendment with follow-up visits at 7 & 10 years for eligible subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
554 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Barricaid Device
Arm Type
Experimental
Arm Description
Intervention: Barricaid Device
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Standard (Limited) Discectomy Only
Intervention Type
Device
Intervention Name(s)
Barricaid
Intervention Description
Annular closure device
Intervention Type
Device
Intervention Name(s)
Standard of Care
Intervention Description
Standard Limited discectomy
Primary Outcome Measure Information:
Title
Combined success of multiple clinical outcomes, including Oswestry disability index, Visual Analog Scale (VAS), and multiple radiographically confirmed measures
Description
To be considered a success, a patient will have achieved success in each of the following outcomes: 15 point (out of 100 point scale) improvement in Oswestry compared to pre-op 20 point (on a 100 point scale) improvement in VAS Leg (based on the primary leg complaint; if both legs have a minimum of 40/100 pre-operatively, the average leg score will be used) Maintenance of average disc height (75% or greater of preoperative disc height) compared to pre-op No deterioration of neurological status at the index level measured by motor function Device integrity and lack of implant migration (radiographic, implanted patients only) No radiographically confirmed spontaneous fusion No radiographically or surgically confirmed reherniation at the index level (on either side) No secondary surgical interventions at the index level
Time Frame
24 months
Title
No radiographic evidence of recurrent disc herniation
Description
To be considered a success, a patient will have no evidence of recurrent disc herniation at the index level at any time up to and including the 24-month follow-up. Recurrent herniation may be confirmed surgically, or radiographically as determined by an independent review (unless surgically confirmed that the suspected herniation is not a herniation, e.g. scar tissue or residual nucleus material).
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Visual Analog Scale (VAS) Back Pain Improvement
Description
Change in back pain as measured using a Visual Analog Scale (VAS), on a scale of 0-100, with lower values representing better outcome. A subject is a success if there is at least a 20 point improvement on the VAS back at 24 months, relative to baseline.
Time Frame
24 months
Title
Oswestry Disability Index (ODI) Improvement
Description
Change in function as measured using the Oswestry Disability Index (ODI). The ODI is scored on a scale from 0% to 100%, with higher scores indicating higher levels of disability. A subject is a success if there is at least a 15 point improvement (decrease) in the ODI at the 24 month visit relative to baseline.
Time Frame
24 months
Title
Reoperation
Description
A subject will be deemed a success if they have not had a second operation at the index level by the 24 month visit. Rates of subject success in treatment and control will be compared at 24 months. A subject is a success if there is at least 75% of the pre-op disc height preserved at the 24 month visit.
Time Frame
24 months
Title
Visual Analog Scale (VAS) LEG Pain Improvement
Description
Change in leg pain as measured using a Visual Analog Scale (VAS), on a scale of 0-100, with lower values representing better outcome. A subject is a success if there is at least a 20 point improvement on VAS leg pain in the ipsilateral leg at 24 months, relative to baseline.
Time Frame
24 months
Title
Disc Height Maintenance
Description
A subject is a success if there is at least 75% of the pre-op disc height preserved as measured on MRI, at the 24 month visit.
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Post 5Y device or procedure-related Serious Adverse Event (SAE)
Description
Adverse events will be categorized as device-related and/or procedure-related and will be assigned severity or seriousness. Safety will be determined by evaluating the type, frequency, severity, and relationship to device and/or procedure of adverse events through the 10 year time point or until stabilization of the endplate lesions, whichever is longer.
Time Frame
Post 60 months
Title
Post 5Y secondary surgical intervention at the index level
Description
The safety will be supported if the incidence of secondary surgical interventions (SSIs) and the incidence SAEs related to either the device or procedure is not greater in the Barricaid® annular closure device than in the Control cohort.
Time Frame
Post 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 21 to 75 years old and skeletally mature (male or female). Patients with posterior or posterolateral disc herniations at one level between L1 and S1 with radiographic confirmation of neural compression using Magnetic Resonance Imaging (MRI). At least six (6) weeks of failed, conservative treatment prior to surgery Oswestry Disability Index (ODI) Questionnaire score of at least 40/100 at baseline. Visual Analog Scale (VAS) leg pain (one or both legs) of at least 40/100 at baseline. Psychosocially, mentally and physically able to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements. Exclusion Criteria: Spondylolisthesis Grade II or higher (25% slip or greater). Prior surgery at the index lumbar vertebral level. Subject has scoliosis of greater than ten (10) degrees (both angular and rotational). Any metabolic bone disease. Subject has insulin-dependent diabetes mellitus. Subject has been diagnosed with active hepatitis, acquired immunodeficiency syndrome (AIDS), or Human immunodeficiency virus (HIV). Subject has been diagnosed with rheumatoid arthritis or other autoimmune disease. Subject has a known allergy to titanium, polyethylene or polyester materials. Any subject that cannot have a baseline MRI taken. Subject is pregnant or interested in becoming pregnant in the next three (3) years. Subject has active tuberculosis or has had tuberculosis in the past three (3) years. Subject is currently involved in another investigational study. Any contraindication for MRI or Computed tomography CT scan (e.g. claustrophobia, contrast allergy).
Facility Information:
Facility Name
LKH Graz
City
Graz
Country
Austria
Facility Name
Medizinische Universität Innsbruck
City
Innsbruck
Country
Austria
Facility Name
OLV Aalst
City
Aalst
Country
Belgium
Facility Name
ZNA Middleheim / AZ Klina
City
Antwerp
Country
Belgium
Facility Name
AZ Nikolaas
City
Sint Niklaas
Country
Belgium
Facility Name
CHRU Lille, Hôpital Roger Salengro
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Orthopädische Klinik und Poliklinik - Universitätsmedizin Rostock
City
Rostock
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
D-18055
Country
Germany
Facility Name
Neurochirurgische Universitätsklinik Knappschafts-Krankenhaus Bochum-Langendreer
City
Bochum
State/Province
North Rhine-Westphalia
ZIP/Postal Code
44892
Country
Germany
Facility Name
Klinikum Augsburg
City
Augsburg
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
Country
Germany
Facility Name
Klinikum Deggendorf
City
Deggendorf
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf
City
Düsseldorf
Country
Germany
Facility Name
Asklepios Westklinikum Hamburg
City
Hamburg
Country
Germany
Facility Name
UNI Kiel
City
Kiel
Country
Germany
Facility Name
St. Bonifatius Hospital GmbH
City
Lingen
Country
Germany
Facility Name
UMM Mannheim
City
Mannheim
Country
Germany
Facility Name
SLAZ Amsterdam
City
Amsterdam
Country
Netherlands
Facility Name
MCH Westeinde
City
Den Haag
Country
Netherlands
Facility Name
MCH Antoniushove
City
Leidschendam
Country
Netherlands
Facility Name
Isala Klinieken
City
Zwolle
ZIP/Postal Code
8025AB
Country
Netherlands
Facility Name
KSA Aarau
City
Aarau
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
29730458
Citation
Thome C, Klassen PD, Bouma GJ, Kursumovic A, Fandino J, Barth M, Arts M, van den Brink W, Bostelmann R, Hegewald A, Heidecke V, Vajkoczy P, Frohlich S, Wolfs J, Assaker R, Van de Kelft E, Kohler HP, Jadik S, Eustacchio S, Hes R, Martens F; Annular Closure RCT Study Group. Annular closure in lumbar microdiscectomy for prevention of reherniation: a randomized clinical trial. Spine J. 2018 Dec;18(12):2278-2287. doi: 10.1016/j.spinee.2018.05.003. Epub 2018 May 3.
Results Reference
result
PubMed Identifier
30280130
Citation
Martens F, Vajkoczy P, Jadik S, Hegewald A, Stieber J, Hes R. Patients at the Highest Risk for Reherniation Following Lumbar Discectomy in a Multicenter Randomized Controlled Trial. JB JS Open Access. 2018 Apr 16;3(2):e0037. doi: 10.2106/JBJS.OA.17.00037. eCollection 2018 Jun 28.
Results Reference
result
PubMed Identifier
29983583
Citation
Klassen PD, Hsu WK, Martens F, Inzana JA, van den Brink WA, Groff MW, Thome C. Post-lumbar discectomy reoperations that are associated with poor clinical and socioeconomic outcomes can be reduced through use of a novel annular closure device: results from a 2-year randomized controlled trial. Clinicoecon Outcomes Res. 2018 Jun 26;10:349-357. doi: 10.2147/CEOR.S164129. eCollection 2018.
Results Reference
result
PubMed Identifier
29927860
Citation
Ament J, Thaci B, Yang Z, Kulubya E, Hsu W, Bouma G, Kim KD. Cost-effectiveness of a Bone-anchored Annular Closure Device Versus Conventional Lumbar Discectomy in Treating Lumbar Disc Herniations. Spine (Phila Pa 1976). 2019 Jan 1;44(1):5-16. doi: 10.1097/BRS.0000000000002746.
Results Reference
result
PubMed Identifier
29538243
Citation
Kursumovic A, Kienzler JC, Bouma GJ, Bostelmann R, Heggeness M, Thome C, Miller LE, Barth M; Annular Closure RCT study group. Morphology and Clinical Relevance of Vertebral Endplate Changes Following Limited Lumbar Discectomy With or Without Bone-anchored Annular Closure. Spine (Phila Pa 1976). 2018 Oct 15;43(20):1386-1394. doi: 10.1097/BRS.0000000000002632.
Results Reference
result
PubMed Identifier
28894388
Citation
Klassen PD, Bernstein DT, Kohler HP, Arts MP, Weiner B, Miller LE, Thome C. Bone-anchored annular closure following lumbar discectomy reduces risk of complications and reoperations within 90 days of discharge. J Pain Res. 2017 Aug 26;10:2047-2055. doi: 10.2147/JPR.S144500. eCollection 2017. Erratum In: J Pain Res. 2017 Dec 06;10 :2739.
Results Reference
result
PubMed Identifier
34882183
Citation
Thome C, Kursumovic A, Klassen PD, Bouma GJ, Bostelmann R, Martens F, Barth M, Arts M, Miller LE, Vajkoczy P, Hes R, Eustacchio S, Nanda D, Kohler HP, Brenke C, Fluh C, Van de Kelft E, Assaker R, Kienzler JC, Fandino J; Annular Closure RCT Study Group. Effectiveness of an Annular Closure Device to Prevent Recurrent Lumbar Disc Herniation: A Secondary Analysis With 5 Years of Follow-up. JAMA Netw Open. 2021 Dec 1;4(12):e2136809. doi: 10.1001/jamanetworkopen.2021.36809.
Results Reference
derived
PubMed Identifier
33085021
Citation
Kienzler JC, Fandino J, Van de Kelft E, Eustacchio S, Bouma GJ; Barricaid(R) Annular Closure RCT Study Group. Risk factors for early reherniation after lumbar discectomy with or without annular closure: results of a multicenter randomized controlled study. Acta Neurochir (Wien). 2021 Jan;163(1):259-268. doi: 10.1007/s00701-020-04505-4. Epub 2020 Oct 21.
Results Reference
derived
PubMed Identifier
31689835
Citation
van den Brink W, Fluh C, Miller LE, Klassen PD, Bostelmann R. Lumbar disc reherniation prevention with a bone-anchored annular closure device: 1-year results of a randomized trial. Medicine (Baltimore). 2019 Nov;98(44):e17760. doi: 10.1097/MD.0000000000017760.
Results Reference
derived
PubMed Identifier
31089894
Citation
Kienzler JC, Klassen PD, Miller LE, Assaker R, Heidecke V, Frohlich S, Thome C; Annular Closure RCT Study Group. Three-year results from a randomized trial of lumbar discectomy with annulus fibrosus occlusion in patients at high risk for reherniation. Acta Neurochir (Wien). 2019 Jul;161(7):1389-1396. doi: 10.1007/s00701-019-03948-8. Epub 2019 May 15.
Results Reference
derived
Links:
URL
http://www.barricaid.com
Description
Sponsor website
URL
http://www.ijclinicaltrials.com/index.php/ijct/article/view/137/84
Description
Published protocol design manuscript

Learn more about this trial

A Prospective, Randomized, Multicenter Study to Demonstrate the Superiority of the Barricaid to Discectomy for Primary Lumbar Disc Herniation

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