Lumbar Disc Herniation Clinical Trial
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
Verified date | September 2023 |
Source | Intrinsic Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 554 |
Est. completion date | June 2025 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 75 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Austria | LKH Graz | Graz | |
Austria | Medizinische Universität Innsbruck | Innsbruck | |
Belgium | OLV Aalst | Aalst | |
Belgium | ZNA Middleheim / AZ Klina | Antwerp | |
Belgium | AZ Nikolaas | Sint Niklaas | |
France | CHRU Lille, Hôpital Roger Salengro | Lille | |
Germany | Klinikum Augsburg | Augsburg | |
Germany | Charité - Universitätsmedizin Berlin | Berlin | |
Germany | Neurochirurgische Universitätsklinik Knappschafts-Krankenhaus Bochum-Langendreer | Bochum | North Rhine-Westphalia |
Germany | Klinikum Deggendorf | Deggendorf | |
Germany | Universitätsklinikum Düsseldorf | Düsseldorf | |
Germany | Asklepios Westklinikum Hamburg | Hamburg | |
Germany | UNI Kiel | Kiel | |
Germany | St. Bonifatius Hospital GmbH | Lingen | |
Germany | UMM Mannheim | Mannheim | |
Germany | Orthopädische Klinik und Poliklinik - Universitätsmedizin Rostock | Rostock | Mecklenburg-Vorpommern |
Netherlands | SLAZ Amsterdam | Amsterdam | |
Netherlands | MCH Westeinde | Den Haag | |
Netherlands | MCH Antoniushove | Leidschendam | |
Netherlands | Isala Klinieken | Zwolle | |
Switzerland | KSA Aarau | Aarau |
Lead Sponsor | Collaborator |
---|---|
Intrinsic Therapeutics |
Austria, Belgium, France, Germany, Netherlands, Switzerland,
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 — View 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 — View 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 — View 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 — View 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. — View 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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Post 5Y device or procedure-related Serious Adverse Event (SAE) | 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. | Post 60 months | |
Other | Post 5Y secondary surgical intervention at the index level | 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. | Post 60 months | |
Primary | 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 |
24 months | |
Primary | 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). | 24 months | |
Secondary | 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. | 24 months | |
Secondary | 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. | 24 months | |
Secondary | 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. | 24 months | |
Secondary | 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. | 24 months | |
Secondary | 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. | 24 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05277818 -
Post-marketing Clinical Follow-up of the Medical Device DIVA®
|
||
Recruiting |
NCT05467072 -
PMCFU of an Annular Closure System
|
||
Withdrawn |
NCT03252691 -
Incidence of Large Annular Defects in Primary Lumbar Discectomy Patients
|
||
Withdrawn |
NCT01622413 -
Trial to Show Non-inferiority / Superiority of an Endoscopic Transforaminal Discectomy to Standard Microdiscectomy
|
N/A | |
Completed |
NCT04329598 -
Effects of Whole-Body Electromyostimulation Application in Individuals With Lumbar Disc Hernia
|
N/A | |
Completed |
NCT04061759 -
Physiotherapy in Lumbar Disc Pathologies
|
N/A | |
Completed |
NCT04073095 -
Erector Spinae Plane Block and Modified-Thoracolumbar Interfascial Plane Block Following Lumbar Spinal Surgery
|
N/A | |
Active, not recruiting |
NCT06140862 -
Ankle Spine Syndrome "RAFFET Syndrome II
|
N/A | |
Active, not recruiting |
NCT05613179 -
Brain Effect Mechanism of Lever Positioning Manipulation on LDH Analgesia Based on Multimodal MRI
|
N/A | |
Completed |
NCT04587401 -
The Effects of Anesthesia on Cerebral Perfusion in Patients With High Blood Pressure
|
N/A | |
Recruiting |
NCT05663437 -
Effectiveness of Core Stabilization Exercises With and Without Neural Mobilization Technique in Female Patients With Lumbar Radiculopathy Due to Disc Herniation - an RCT Study
|
N/A | |
Recruiting |
NCT06076408 -
Effects of SNAGS With and Without Pilates in Lumbar Disc Bulge Patients
|
N/A | |
Completed |
NCT05999253 -
Comparison of the Efficacy of Thoracolumbar Interfascial Plane Block and Erector Spina Plane Block in Lumbar Discectomy
|
||
Recruiting |
NCT03002207 -
Repairing the Defect of Intervertebral Disc With Autologous BMSC and Gelatin Sponge After Microendoscopic Discectomy for Lumbar Disc Herniation
|
N/A | |
Not yet recruiting |
NCT05487690 -
Application of 3D Printing Guide Plate in Spinal Minimally Invasive and Interventional Surgeries
|
N/A | |
Completed |
NCT05003726 -
Non-pharmacological Treatment and Pharmacological Treatment for Non-acute Lumbar Disc Herniation
|
N/A | |
Completed |
NCT05556538 -
The Effect of Subcutaneous Fat Tissue Thickness on Lumbar Transforaminal Epidural Steroid Injection Treatment Success
|
||
Not yet recruiting |
NCT04083703 -
Evaluation of Interbody Cage Insertion in Treatment of Lumbar Disc Prolapse
|
N/A | |
Completed |
NCT03832036 -
The Diagnostic and Prognostic Value of Two Quantitative Clinical Tests in Patients With Lumbar Disc Herniation
|
N/A | |
Not yet recruiting |
NCT05584774 -
Percutaneous Endoscopic Lumbar Discectomy Add by Annuloplasty and Nucleoplasty
|
N/A |