The purpose of this post-approval protocol amendment is to extend the follow-up of subjects who were originally enrolled in theRCT, EUBARD-CP_001 protocol. This study extension will examine the long-term survivorship of the Barricaid® ACD when…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
- Spinal cord and nerve root disorders
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary hypotheses of this extended follow-up post approval study extension
are:
• The Barricaid® ACD remains safe and effective at 10 years.
• The Barricaid® ACD subjects do not have late or continued slow growth of
lesions that lead to new or unexpected AEs or
adverse clinical outcomes.
• Development of osteoporosis does not negatively impact the progression of
lesions observed and does not lead to new or
unexpected AEs or adverse clinical outcomes.
Sample size: This study extension is not powered to demonstrate statistical
conclusions, but rather the sample size is based on
the subjects from the original 2-year study who agree to participate in
longer-term follow-up.
Secondary outcome
Long term survivorship will be determined through the evaluation of
1. Device- or procedure-related Serious Adverse Event (SAE)
2. Secondary surgical interventions at the index level
Clinical and radiographic endpoints including both symptomatic and asymptomatic
reherniations, specified in the data collection
sections below may be used in post-hoc analyses between treatment arms.
Specifically, growth and size measurements will be
used to monitor development and progression of new and existing lesions.
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® ACD cohort than in the
Control cohort.
Adverse events will be evaluated by an independent DSMB. 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 and 13 year time point. Stability in this study extension is defined as
less than 35mm2 change in any individual endplate lesion size between follow-up
timepoints. Adverse event type will include events specific to the observation
and/or consequence of endplate lesions.
Background summary
Low back pain and sciatica is often associated with herniation of a lumbar
disc. In the Western society, up to 25 percent of the population may
experience a combination of low back pain or sciatica at some point in life.
If conservative treatment is not successful, surgery may be indicated. Lumbar
discectomy for the treatment of radicular pain from a herniated lumbar disc is
one of the most frequently performed surgical procedures (12,000 operations
annually in the Netherlands). Despite the efficacy of this operation for leg
pain, many patients (7-36%) suffer from persistent low back pain, and 5-18%
will have a recurrent disc herniation requiring surgery. This subgroup of
patients has a high risk of ending up with chronic low back pain, and place a
high financial burden on society because of costs for medical care and economic
loss.
The Barricaid® ARD was developed in an effort to minimize the risk of
recurrence of sciatica, back pain and disc herniation following a lumbar
discectomy. The Barricaid® ARD is a CE-marked permanent implant aimed at
reconstruction of the posterior wall of a bulging disc annulus that has been
treated by limited discectomy. The device acts as an internal mesh closing the
interior surface of the defect in the disc annulus, thus preventing
reherniation of the disc nucleus. By restoring the integrity of the posterior
annulus, the Barricaid® should help to prevent recurrent disc herniation, loss
of disc height with ensuing back pain and sciatica.
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
The Barricaid® Anular Closure Device was approved for marketing in the United
States by the FDA on February 8, 2019
(P160050). As a condition of approval, the manufacturer agreed to conduct a
long-term follow-up on all patients enrolled in the
randomized controlled trial (RCT) titled: A Prospective, Randomized,
Multicenter Study to Demonstrate the Superiority of the
Barricaid® to Discectomy for Primary Lumbar Disc Herniation (EUBARD-CP-001).
The original protocol was approved and instituted at 21 sites and enrolled 554
study subjects. Enrollment of subjects lasted from
December 2010 to October 2014. Subjects were originally scheduled to be
followed until the last patient enrolled in the trial
reached their 24 month follow-up. Subsequently, all ECs approved a protocol
addendum that allowed all patients to be followed for
a total of 60 months (5 years).
Study endpoints of the original protocol included radiographic and clinical
outcomes including reherniation, reoperation, pain, and
disability. Components of the radiographic evaluations included Modic changes,
device integrity, disc height, and endplate changes
(EPCs). EPC frequency, size, change in growth, and correlation to clinical
outcomes were evaluated. To date, there have been no
serious adverse events associated with EPCs in the Barricaid patient cohort.
Study objective
The purpose of this post-approval protocol amendment is to extend the follow-up
of subjects who were originally enrolled in the
RCT, EUBARD-CP_001 protocol. This study extension will examine the long-term
survivorship of the Barricaid® ACD when used
in conjunction with limited discectomy. This study extension is also intended
to monitor the natural history of endplate lesions due
to interactions with the device, potential interactions with the development of
osteoporosis, lesion growth and lesion stability. The
study is also intended to investigate potential underlying mechanisms that may
contribute to any additional growth through retrieval
analysis and histological analysis of peri-prosthetic tissue.
Study design
Postmarket Cohort documenting the Extended Follow-Up of the Barricaid® Annular
Closure Device (ACD) Randomized Control
Trial (RCT) in patients undergoing a limited discectomy for Lumbar Disc
Herniation
This is a prospective, controlled, continued long-term follow-up evaluation of
patients originally randomized into the RCT,
EUBARD-CP-001.
Intervention
Barricaid® group:
primary lumbar microdiscectomy followed by implantation of the Barricaid device
in the posterior annulus defect.
Control group:
primary lumbar microdiscectomy alone (Spengler, 1982), without placement of
Barricaid.
Study burden and risks
This post-approval protocol would follow all subjects through 10 years (10 and
13 year timepoints) with follow-up estimated to be
completed in December, 2025.
• 10/13 year follow-up contact:
o Patient questionnaires (VAS, ODI)
o Adverse event evaluation
o Symptomatic reherniation
o AP/lateral, Flex/Ex, lumbar MRI, low dose CT at index level
* Device Subsidence
* Endplate Lesions - size and growth measurements
* Device Condition/Migration
* Reherniation at index level
o 10 year only: SCORE questionnaire. Femoral neck DEXA scan if required per
SCORE osteoporosis screening questionnaire
(subjects with SCORE of >= 6)
This study includes the use of MRI, X-Ray, CT, and DEXA scans which are not
part of the standard treatment in these
subjects.
In the informed consent, the discomfort and risk of the MRI, X-rays, CT and
Dexa is explained. MRI may cause discomfort,
claustrofobia, ear protection should be worn and there might be unknown
negative effects of the electromagnetic fields. For the Xray
investigations, including the low dose CT, the amount of radiation involved is
explained and put into perspective: it is equal to an amount every person is
subjected over the course of 2-3 months: 0,54mSv. For the CT investigation,
there may also be discomfort and claustrofobia. Finally, a Dexa scan only
causes a small amount of radiation, less than the ampount received in one day.
This long-term follow-up of subjects who were originally enrolled in the RCT,
EUBARD-CP_001 protocol will examine the long-term
survivorship of the Barricaid® ACD when used in conjunction with limited
discectomy. This study extension is also intended to
monitor the natural history of endplate lesions due to interactions with the
device, potential interactions with the development of
osteoporosis, lesion growth and lesion stability. The study is also intended to
investigate potential underlying mechanisms that may
contribute to any additional growth through retrieval analysis and histological
analysis of peri-prosthetic tissue. This research is
justified to investigate whether the benefits of the Barricaid annular closure
device used in conjunction with a limited discectomy,
as compared to limited discectomy only, as demonstrated at the 2 and 5-year
follow-up intervals, can indeed be confirmed over a
longer period of time.
Gerresheimer Landstrasse 127
Düsseldorf D-40627
DE
Gerresheimer Landstrasse 127
Düsseldorf D-40627
DE
Listed location countries
Age
Inclusion criteria
Only subjects enrolled in the original RCT protocol EUBARD-CP-001 will be
eligible for long-term follow-up.
Original inclusion criteria included: subjects with radiculopathy (with or
without back pain), a positive straight leg raise (L4-5, L5-S1) or femoral
stretch test (L1-2, L2-3, L3-4), 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 anular defect (post discectomy)
which measures between 4mm and 6mm tall and between 6mm and 10mm wide, with a
minimum posterior disc height of 5mm, and failed at least 6 weeks of
conservative treatment.
Exclusion criteria
Only subjects enrolled in the original RCT protocol EUBARD-CP-001 will be
eligible for long-term follow-up.
Subjects who have died or withdrawn consent during follow-up of RCT
EUBARD-CP-001 will not be included in the patient population eligible for this
long-term evaluation.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01283438 |
| CCMO | NL32866.029.10 |