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

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01283438
• Other study ID #: EUBARD-CP-011
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: December 17, 2010
• Est. completion date: June 2025

Study information

• Verified date: September 2023
• Source: Intrinsic Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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).

Related Conditions & MeSH terms

• Hernia
• Intervertebral Disc Displacement
• Lumbar Disc Herniation

Intervention

Device:
• Barricaid
Annular closure device
• Standard of Care
Standard Limited discectomy

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Intrinsic Therapeutics

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Netherlands,  Switzerland, 

References & Publications (6)

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

Outcome

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

External Links

•   Published protocol design manuscript
•   Sponsor website