Activ-L™ Artificial Disc Treatment of Degenerative Disc Disease in the Treatment of Degenerative Disc Disease



Status:Completed
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - 60
Updated:12/9/2018
Start Date:January 2007
End Date:January 2017

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Clinical Study to Evaluate the Safety and Effectiveness of the Aesculap Activ-L™ Artificial Disc in the Treatment of Degenerative Disc Disease

The purpose of this study is to learn whether an investigational device called the Activ-L
Artificial Disc is safe and effective in the treatment of degenerative disc disease of the
lower (lumbar) spine.

The objective of this clinical study is to evaluate the safety and effectiveness of the
Activ-L Artificial Disc for treatment of single-level degenerative disc disease of the lumbar
spine in patients who have been unresponsive to at least six months of prior conservative
care. The hypothesis of the study is that the Activ-L Disc is non-inferior to the control
(the Charité® Artificial Disc [DePuy Spine] or ProDisc-L® Total Disc Replacement [Synthes
Spine]) with respect to the rate of individual subject success at 24 months. Individual
subject success is a composite of effectiveness and safety.

Inclusion Criteria:

- Age 18 - 60, skeletally mature

- Symptomatic DDD with objective evidence of lumbar DDD, with any of the following
characteristics by MRI scan:

- instability as defined by ≥ 3mm translation or ≥ 5° angulation.

- osteophyte formation of facet joints or vertebral endplates.

- decreased disc height of >2mm as compared to the adjacent level.

- scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint
capsule.

- herniated nucleus pulposus.

- facet joint degeneration/changes.

- vacuum phenomenon.

- Single level symptomatic disease at L4/L5 or L5/S1.

- six months of unsuccessful conservative treatment

- ODI score ≥ 40/100.

- Surgical candidate for an anterior approach to the lumbar spine.

- Back pain at the operative level only, with or without leg pain.

- Back pain VAS score greater than the higher of the two VAS leg pain scores.

- VAS back pain score ≥ 40/100 mm.

- Willing to return for follow-up visits and sign an Informed Consent and HIPAA
Authorization.

Exclusion Criteria:

- Previous surgery at any lumbar level, except IDET (Intradiscal Electrothermal
Annuloplasty), percutaneous nucleoplasty, or microdiscectomy.

- Chronic radiculopathy, i.e., subject complaint of unremitting pain with a predominance
of leg pain symptoms greater than back pain symptoms extending over a period of at
least 1 year.

- endplate dimensions smaller than 34.5 mm in medial-lateral and/or 27 mm in the
anterior-posterior direction

- Evidence of significant, symptomatic disc degeneration at another lumbar level.

- Preoperative remaining disc height < 3mm

- Myelopathy.

- Previous compression or burst fracture at the affected level.

- Sequestered herniated nucleus pulposus with migration.

- Mid-sagittal stenosis of <8mm (by MRI).

- Degenerative or lytic spondylolisthesis > 3mm.

- Spondylolysis.

- Isthmic spondylolisthesis.

- Lumbar scoliosis (> 11 degrees of sagittal plane deformity).

- Spinal tumor.

- Active systemic infection or infection at the site of surgery.

- Facet ankylosis or severe facet degeneration.

- Continuing steroid use or prior use for more than 2 months.

- History of allergies to any of the device components.

- Pregnancy or planning to become pregnant within the next 2 years.

- Morbid obesity (BMI >35).

- Investigational drug or device use within 30 days.

- Osteoporosis or osteopenia

- Metabolic bone disease.

- Leg pain with migrated sequestrum fragment.

- History of rheumatoid arthritis, lupus, or other autoimmune disorder.

- Ankylosing spondylitis.

- History of HIV/AIDS or hepatitis that precludes surgery.

- History of deep vein thrombosis, symptoms of arterial insufficiency, or
thromboembolytic disease.

- Current or recent history of illicit drug or alcohol abuse, or dependence as defined
as the continued use of alcohol despite the development of social, legal, or health
problems.

- Life expectancy <5 years.

- Chemotherapy within past 5 years or any cancer other than non-melanoma skin cancer
treated with curative intent within the past 5 years.

- Prior nephrectomy.

- Abdominal adhesions, endometriosis, inflammatory bowel disease, Crohn's disease,
diverticulitis, ulcerative colitis or other abdominal pathology that would preclude
abdominal surgical approach.

- Insulin-dependent diabetes.

- Any degenerative muscular or neurological condition that would interfere with
evaluation of outcomes, including but not limited to Parkinson's disease, ALS
(amyotrophic lateral sclerosis), or multiple sclerosis.

- History of Pelvic Inflammatory Disease.

- Peritonitis.

- Currently in active spinal litigation as a result of medical negligence.

- Prisoner.

- Psychiatric or cognitive impairment that would interfere with the subject's ability to
comply with the study requirements, e.g., Alzheimer's disease.
We found this trial at
17
sites
Erie, Pennsylvania 16550
2118
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Erie, PA
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
572
mi
from 91732
Salt Lake City, UT
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825
mi
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Aurora, CO
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Aventura, Florida 33180
2319
mi
from 91732
Aventura, FL
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1000 Blythe Blvd
Charlotte, North Carolina 28203
2102
mi
from 91732
Charlotte, NC
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
1726
mi
from 91732
Chicago, IL
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
2036
mi
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Cleveland, OH
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La Jolla, California 92037
95
mi
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La Jolla, CA
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1575 Beam Avenue
Maplewood, Minnesota 55109
1521
mi
from 91732
Maplewood, MN
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333 Cedar Street
New Haven, Connecticut 06520
2486
mi
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New Haven, CT
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535 E 70th St
New York, New York 10021
(212) 606-1000
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
2434
mi
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New York, NY
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Newport Beach, California 92658
33
mi
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Newport Beach, CA
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1618
mi
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Peoria, IL
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10841 White Oak Avenue
Rancho Cucamonga, California 91730
25
mi
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Rancho Cucamonga, CA
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San Francisco, California 94143
356
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San Francisco, CA
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2121 Santa Monica Boulevard
Santa Monica, California 90404
26
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Santa Monica, CA
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Tampa, Florida 33613
2133
mi
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Tampa, FL
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