Degenerative Disc DiseasePhase 3NCT00316121

Safety and Efficacy Study of Healos as a Bone Replacement to Treat Degenerative Disc Disease

A Phase 3 study testing HEALOS and Leopard Cage and Leopard Cage and Autograft in people with Degenerative Disc Disease, run by Advanced Technologies and Regenerative Medicine, LLC (ATRM) 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

Search all trials

Trial summary

The purpose of this study is to determine the safety and effectiveness of HEALOS compared with autograft using the transforaminal lumbar interbody fusion (TLIF) method. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Degenerative Disc Disease
What is being tested?: HEALOS and Leopard Cage and Leopard Cage and Autograft
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 138 participants
Where: 17 sitesUnited States
Study dates: Apr 2006to Jan 2010
Phase: Phase 3
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Persistent back and/or leg pain refractory to 6 months of non-surgical therapy
Male or female 18 to 70 years of age (inclusive)
Objective evidence of significant disc degeneration at one or two adjacent lumbar level(s) from L2/L3 to L5/S1

Who cannot join

Significant disc degeneration at more than two adjacent levels
Greater than Grade II spondylolisthesis
Prior fusion surgery of the lumbar spine (prior discectomies and intradiscal electrothermal therapy [IDET] are allowed)
Insulin-dependent diabetes mellitus
Pregnant or lactating, or wishes to become pregnant within the 24 month duration of the study

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

Study site
Annapolis, Maryland, 21401
Study site
Beverly Hills, California, 90211
Study site
Billings, Montana, 59101
Study site
Brandon, Florida, 33511
Study site
Chicago, Illinois, 60611
Study site
Eugene, Oregon, 97401
Study site
Indianapolis, Indiana, 46260
Study site
Jacksonville, Florida, 32204
Study site
Little Rock, Arkansas, 72205
Study site
Milwaukee, Wisconsin, 53233
Study site
Norwood, Ohio, 45212
Study site
Oklahoma City, Oklahoma, 73104
Study site
Salt Lake City, Utah, 84108
Study site
Savannah, Georgia, 31405
Study site
Spokane, Washington, 99218
Study site
Temple, Texas, 76508
Study site
Williamsville, New York, 14221

Other trials in United States

About this study

Official title: A Prospective, Multicenter, Randomized Study Comparing the Use of HEALOS® to Autograft in a Transforaminal Lumbar Interbody Fusion (TLIF) Approach

The purpose of this study is to determine the safety and effectiveness of HEALOS compared with autograft using the transforaminal lumbar interbody fusion (TLIF) method.

Conditions: Degenerative Disc Disease
Being tested: HEALOS and Leopard Cage, Leopard Cage and Autograft
Keywords: One or Two Level Degenerative Disc Disease
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.

HEALOS and Leopard CageDevice
Placement in interbody space
Leopard Cage and AutograftDevice
Placement in the interbody space

Study groups in NCT00316121
Study group	Role	What they receive
1	Experimental	Not described Receives: Device: HEALOS and Leopard Cage
2	Active comparator	Not described Receives: Device: Leopard Cage and Autograft

What is being measured

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

Subject Success (Success is Defined Only if All of These Criteria Are Fulfilled)
Success is bridging bone, slip of study level versus adjacent levels less than 3 millimeters, angulation less than 5 degrees, 15 point increase in Oswestry Disability Index (ODI) (how back/leg trouble affects activities of daily living), no new problems in motor strength in legs, presence/absence of pain on leg raise, sensation intact on thigh/leg/foot reflexes of the knees/ankles, no permanent/serious complications, no revision/removal/reoperation/supplemental fixation. The ODI is on a 6 point scale from 0 (no pain/no impact on duties) to 5 (worst pain ever/unable to perform duties).
Measured: 24 months

Timeline

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

Apr 2006Jan 2010

First posted20 Apr 2006 (estimated)
Study startApr 2006
Primary completionJan 2010

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.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 138 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00316121
Sponsor's protocol ID: 05-HEALOS-01
Status last verified: Feb 2011
First submitted: 18 Apr 2006
Last updated: 3 Mar 2011
Results posted: Yes, on ClinicalTrials.gov

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

Not yet recruiting
CANLINK: Evaluation of the Intralink Intradiscal Device for Low Back Pain Due to Degenerative Disc Disease
Degenerative Disc Disease(DDD)
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Degenerative Disc Disease, Disc Degeneration
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

All Degenerative Disc Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicenter, Randomized Study Comparing the Use of HEALOS® to Autograft in a Transforaminal Lumbar Interbody Fusion (TLIF) Approach
ClinicalTrials.gov ID: NCT00316121
Acronym / sponsor ID: 05-HEALOS-01
Conditions: Degenerative Disc Disease
Keywords: One or Two Level Degenerative Disc Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 138 participants (actual)
Lead sponsor: Advanced Technologies and Regenerative Medicine, LLC (ATRM)University, hospital or other
Collaborators: DePuy Spine
Study start: Apr 2006
Primary completion: Jan 2010 (actual)
First posted: 20 Apr 2006 (estimated)
Results: Posted 3 Mar 2011

Clinical summary

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

The purpose of this study is to determine the safety and effectiveness of HEALOS compared with autograft using the transforaminal lumbar interbody fusion (TLIF) method.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Device: HEALOS and Leopard Cage
2	Active comparator	Device: Leopard Cage and Autograft

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Persistent back and/or leg pain refractory to 6 months of non-surgical therapy
Male or female 18 to 70 years of age (inclusive)
Objective evidence of significant disc degeneration at one or two adjacent lumbar level(s) from L2/L3 to L5/S1

Key exclusion criteria (5 listed)

Significant disc degeneration at more than two adjacent levels
Greater than Grade II spondylolisthesis
Prior fusion surgery of the lumbar spine (prior discectomies and intradiscal electrothermal therapy [IDET] are allowed)
Insulin-dependent diabetes mellitus
Pregnant or lactating, or wishes to become pregnant within the 24 month duration of the study

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
HEALOS and Leopard CagePlacement in interbody space	Device	1
Leopard Cage and AutograftPlacement in the interbody space	Device	2

Primary outcome

Subject Success (Success is Defined Only if All of These Criteria Are Fulfilled)
Time frame: 24 months
Success is bridging bone, slip of study level versus adjacent levels less than 3 millimeters, angulation less than 5 degrees, 15 point increase in Oswestry Disability Index (ODI) (how back/leg trouble affects activities of daily living), no new problems in motor strength in legs, presence/absence of pain on leg raise, sensation intact on thigh/leg/foot reflexes of the knees/ankles, no permanent/serious complications, no revision/removal/reoperation/supplemental fixation. The ODI is on a 6 point scale from 0 (no pain/no impact on duties) to 5 (worst pain ever/unable to perform duties).

Results and safety

Results posted to the registry on 3 Mar 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HEALOS	92	70
Control	46	37

Primary outcome: Subject Success (Success is Defined Only if All of These Criteria Are Fulfilled)

Time frame: 24 months. Number. Unit: Subjects

Measure	HEALOS n = 71	Control n = 39
Value	0 (0.0 to 5.1)	0 (0.0 to 9.0)

Population analysed: Safety Population:All subjects treated. Full Analysis Set(FAS):Subset of Safety Pop. w/follow up. All effectiveness measures were to be assessed on FAS. FAS is intent-to-treat pop. Per Protocol: Subset of FAS who complete study, treated as randomized w/no major protocol deviations. All analyses were to be on this subset.

Adverse events

Time frame: 4 years and 7 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HEALOS	23 of 92 (25%)	77 of 92 (83.7%)	Not reported
Control	13 of 46 (28.3%)	43 of 46 (93.5%)	Not reported

Limitations and caveats (from the sponsor): Stringent criteria for endpoint.Minimum sample size not reached; no hypothesis testing.High portion of current/prior smokers in both groups may impact fusion success.Product usage was appropriate and not low.This study is not on label for HEALOS.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Degenerative Disc Disease

Not yet recruiting
CANLINK: Evaluation of the Intralink Intradiscal Device for Low Back Pain Due to Degenerative Disc Disease
Degenerative Disc Disease(DDD)
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Degenerative Disc Disease, Disc Degeneration
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.

The record lists no contact. Use the official record to reach the sponsor.

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 3 inclusion and 5 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 3 Mar 2011. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2011). 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?

Subject Success (Success is Defined Only if All of These Criteria Are Fulfilled) (time frame: 24 months). 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 NCT00316121.

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 3 Mar 2011.