Degenerative Disc DiseaseNCT00589797

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

A study testing Activ-L Artificial Disc and ProDisc-L Total Disc Replacement or Charité Artificial Disc in people with Degenerative Disc Disease, run by Aesculap Implant Systems at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Degenerative Disc Disease
What is being tested?: Activ-L Artificial Disc and ProDisc-L Total Disc Replacement or Charité Artificial Disc
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 376 participants
Where: 17 sitesUnited States
Study dates: Jan 2007to Jan 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Show all 17Show fewer

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.

Who cannot join

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.

Show all 40Show fewer

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.

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

University of Colorado Health Sciences Center
Aurora, Colorado, 80045
Aventura Hospital and Medical Center
Aventura, Florida, 33180
Carolinas Healthcare
Charlotte, North Carolina, 28203
Rush University Medical Center
Chicago, Illinois, 60612
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Hamot Medical Center
Erie, Pennsylvania, 16507
Scripps Memorial Hospital La Jolla
La Jolla, California, 92037
HealthEast St. John's Hospital
Maplewood, Minnesota, 55109
Yale University School of Medicine/New Haven Hospital
New Haven, Connecticut, 06520
Hospital for Special Surgery
New York, New York, 10021
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658
Neurosciences Education and Research Foundation
Peoria, Illinois, 61605
Rancho Specialty Hospital
Rancho Cucamonga, California, 91730
University of Utah
Salt Lake City, Utah, 84112
University of California San Francisco
San Francisco, California, 94143
St. John's Hospital and Health Center
Santa Monica, California, 90404
University Community Hospital
Tampa, Florida, 33613

Other trials in United States

About this study

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

Read the detailed description

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.

Conditions: Degenerative Disc Disease
Being tested: Activ-L Artificial Disc, ProDisc-L Total Disc Replacement or Charité Artificial Disc
Keywords: Degenerative, Disc
Medical subject headings: Intervertebral Disc Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Activ-L Artificial DiscDevice
Implantation at one level of the lumbar spine, either L4/L5 or L5/S1.
ProDisc-L Total Disc Replacement or Charité Artificial DiscDevice
Implantation at one level of the lumbar spine, either L4/L5 or L5/S1.

Study groups in NCT00589797
Study group	Role	What they receive
Investigational	Experimental	Implantation of the Activ-L Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1. Receives: Device: Activ-L Artificial Disc
Control	Active comparator	Implantation of either the ProDisc-L Total Disc Replacement or Charité Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1. Receives: Device: ProDisc-L Total Disc Replacement or Charité Artificial Disc

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Success at 24 Months Relative to Baseline
Measured by absence of treatment failure; absence or serious device related AE; maintenance or improvement of ROM at index level; maintenance or improvement of neurological status; improvement in ODI score.
Measured: 24 months
Device Success
Percent of subjects demonstrating no Subsequent Surgical Interventions (SSI's) at the index level (L4-L5 or L5-S1) at 24 months.
Measured: 24 months
Absence of Serious Device Related Adverse Events
Percent of subjects demonstrating no device related SAE's at 24 months as per the Clinical Events Committee (CEC)
Measured: 24 months
Range of Motion (ROM) Success
Percent of subjects demonstrating maintenance or improvement in ROM at 24 months compared to baseline
Measured: 24 months
Neurological Success
Percent of patients demonstrating maintenance or improvement in combined motor and sensory evaluations at 24 months compared to baseline
Measured: 24 months
ODI Success
Percent of subjects demonstrating an improvement of greater than or equal to 15 points at 24 months compared to baseline
Measured: 24 months

Secondary outcomes (3)

VAS Success for Back and Leg Pain at Rest
Number of patients demonstrating improvement in back and leg pain at 24 months compared to baseline
Measured: 24 months
ODI Success Using Two Measures of Success
Number of subjects demonstrating improvement in two measures of ODI success at 24 months compared to baseline
Measured: 24 months
Improvement in SF-36 Scores
Number of subjects demonstrating a greater than or equal to 15% improvement in mental (MCS) and physical (PCS) component summary scores at 24 months compared to baseline
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2007Jan 2017

First posted10 Jan 2008 (estimated)
Study startJan 2007
Primary completionDec 2012
Study completionJan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 376 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00589797
Sponsor's protocol ID: ASC-01
Status last verified: Nov 2018
First submitted: 26 Dec 2007
Last updated: 7 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Yue JJ, Mo FF. Clinical study to evaluate the safety and effectiveness of the Aesculap Activ-L artificial disc in the treatment of degenerative disc disease. BMC Surg. 2010 Apr 9;10:14. doi: 10.1186/1471-2482-10-14.
PubMed 20380708

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Degenerative Disc Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study to Evaluate the Safety and Effectiveness of the Aesculap Activ-L™ Artificial Disc in the Treatment of Degenerative Disc Disease
ClinicalTrials.gov ID: NCT00589797
Acronym / sponsor ID: ASC-01
Conditions: Degenerative Disc Disease
Keywords: Degenerative, Disc
Study type: Interventional
Recruitment status: Completed
Enrolment: 376 participants (actual)
Lead sponsor: Aesculap Implant SystemsIndustry (pharma, biotech, devices)
Study start: Jan 2007
Primary completion: Dec 2012 (actual)
Study completion: Jan 2017 (actual)
First posted: 10 Jan 2008 (estimated)
Results: Posted 7 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Investigational	Experimental	Device: Activ-L Artificial DiscImplantation of the Activ-L Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1.
Control	Active comparator	Device: ProDisc-L Total Disc Replacement or Charité Artificial DiscImplantation of either the ProDisc-L Total Disc Replacement or Charité Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (17 listed)

Age 18 - 60, skeletally mature
Symptomatic DDD with objective evidence of lumbar DDD, with any of the following characteristics by MRI scan:
Single level symptomatic disease at L4/L5 or L5/S1.
ODI score ≥ 40/100.
Surgical candidate for an anterior approach to the lumbar spine.

Key exclusion criteria (40 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Activ-L Artificial DiscImplantation at one level of the lumbar spine, either L4/L5 or L5/S1.	Device	Investigational
ProDisc-L Total Disc Replacement or Charité Artificial DiscImplantation at one level of the lumbar spine, either L4/L5 or L5/S1.	Device	Control

Primary outcome

Overall Success at 24 Months Relative to Baseline
Time frame: 24 months
Measured by absence of treatment failure; absence or serious device related AE; maintenance or improvement of ROM at index level; maintenance or improvement of neurological status; improvement in ODI score.
Device Success
Time frame: 24 months
Percent of subjects demonstrating no Subsequent Surgical Interventions (SSI's) at the index level (L4-L5 or L5-S1) at 24 months.
Absence of Serious Device Related Adverse Events
Time frame: 24 months
Percent of subjects demonstrating no device related SAE's at 24 months as per the Clinical Events Committee (CEC)
Range of Motion (ROM) Success
Time frame: 24 months
Percent of subjects demonstrating maintenance or improvement in ROM at 24 months compared to baseline
Neurological Success
Time frame: 24 months
Percent of patients demonstrating maintenance or improvement in combined motor and sensory evaluations at 24 months compared to baseline
ODI Success
Time frame: 24 months
Percent of subjects demonstrating an improvement of greater than or equal to 15 points at 24 months compared to baseline

3 secondary outcomes

VAS Success for Back and Leg Pain at Rest
Time frame: 24 months
ODI Success Using Two Measures of Success
Time frame: 24 months
Improvement in SF-36 Scores
Time frame: 24 months

Results and safety

Results posted to the registry on 7 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Investigational	264	191
Control	112	89

Primary outcome: Overall Success at 24 Months Relative to Baseline

Time frame: 24 months. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Investigational n = 218	Control n = 106
Including ROM success component	42.2 (35.6 to 49.1)	28.3 (20.0 to 37.9)
Without ROM success component	61.9 (55.1 to 68.4)	52.8 (42.9 to 62.6)

Investigational vs Control: p <0.05, t-test, 1 sided

Population analysed: Intent to treat population; missing data imputed as failures

Primary outcome: Device Success

Time frame: 24 months. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Investigational n = 218	Control n = 106
Value	84.4 (78.9 to 89.0)	84.9 (76.6 to 91.1)

Population analysed: Intent to treat population; missing data imputed as failures

Primary outcome: Absence of Serious Device Related Adverse Events

Time frame: 24 months. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Investigational n = 218	Control n = 106
Value	76.6 (70.4 to 82.1)	70.8 (61.1 to 79.2)

Population analysed: Intent to treat population; missing data imputed as failures

Primary outcome: Range of Motion (ROM) Success

Time frame: 24 months. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Investigational n = 218	Control n = 106
Value	58.7 (51.9 to 65.3)	42.5 (32.9 to 52.4)

Population analysed: Intent to treat population; missing data imputed as failures

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Investigational	86 of 218 (39.4%)	197 of 218 (90.4%)	Not reported
Control	57 of 106 (53.8%)	100 of 106 (94.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20380708Yue JJ, Mo FF. Clinical study to evaluate the safety and effectiveness of the Aesculap Activ-L artificial disc in the treatment of degenerative disc disease. BMC Surg. 2010 Apr 9;10:14. doi: 10.1186/1471-2482-10-14.
Individual participant dataSharing planned: No

Related trials for Degenerative Disc Disease

Not yet recruiting
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Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
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ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
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Active, not recruiting
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
Cervical Degenerative Disc Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rolando Garcia, M.D. principal investigator

Orthopedic Care Center

James J Yue, M.D. principal investigator

Yale University

Dom Coric, M.D. principal investigator

Carolina Neurosurgery and Spine Associates

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Success at 24 Months Relative to Baseline (time frame: 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00589797, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2018.