Degenerative Disc DiseaseNCT01494493

Pivotal Study of rhBMP-2/ACS/Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease

A study testing rhBMP-2/ACS/allograft bone dowel and Autogenous bone/allograft bone dowel in people with Degenerative Disc Disease, run by Medtronic Spinal and Biologics.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this clinical trial is to evaluate the implant (rhBMP-2/ACS/allograft bone dowel) as a method of facilitating spinal fusion in patients with degenerative disc disease. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Degenerative Disc Disease
What is being tested?: rhBMP-2/ACS/allograft bone dowel and Autogenous bone/allograft bone dowel
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 85 participants
Where: No sites listed yet
Study dates: Sep 2000to Feb 2004
Phase: Interventional
Are there results?: None posted in the registry

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Has degenerative disc disease as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc confirmed by patient history ( e.g.,pain [leg, back, or symptoms in the sciatic nerve distribution], function deficit and/or neurological deficit)and radiographic studies ( e.g., CT, MRl, X-Ray, etc.) to include one or more of the following:
instability( defined as angular motion > 5° and/or translation >= 2-4mm, based on Flex/Ext radiographs);
osteophyte formation;
decreased disc height;
thickening of ligamentous tissue;
disc degeneration or herniation; and/or

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facet joint degeneration.
Has preoperative Oswestry score > 35.
Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW, 1932.).
Has single-level symptomatic degenerative involvement from L4 to S1.
Is at least 18 years of age, inclusive, at the time of surgery.
Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of at least 6 months.
If female of child-bearing potential, who is not pregnant or nursing, and who agrees to use adequate contraception for 16 weeks following surgery.
Is willing and able to comply with the study plan and sign the Patient Informed Consent Form.

Who cannot join

Had previous anterior spinal fusion surgical procedure at the involved level.
Has posterior spinal instrumentation (which will not be removed) stabilizing the involved level or has had a previous posterior lumbar interbody fusion procedure at the involved level.
Has a condition which requires postoperative medications that interfere with fusion, such as steroids or nonsteroidal antiinflammatory drugs (this does not include low dose aspirin for prophylactic anticoagulation or perioperative steroids).
Has osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
Has overt or active bacterial infection, either local or systemic.

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Is obese, i.e., weight greater than 40% over ideal for their age and height.
Has fever (temperature> 101°F oral) at the time of surgery.
Is mentally incompetent. If questionable, obtain psychiatric consult.
Has a Waddell Signs of Inorganic Behavior score of 3 or greater.
Is a prisoner.
Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse.
Is a tobacco user at the time of surgery.
Has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., steroids or methotrexate).
Has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
Has a history of exposure to injectable collagen implants.
Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following rhBMP-2/ACS implantation.
Has received any previous exposure to any/all BMP's of either human or animal extraction.
Has a history of allergy to bovine products or a history of anaphylaxis.
Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).

About this study

Official title: A Clinical Investigation of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease

The purpose of this clinical trial is to evaluate the implant (rhBMP-2/ACS/allograft bone dowel) as a method of facilitating spinal fusion in patients with degenerative disc disease.

Conditions: Degenerative Disc Disease
Being tested: rhBMP-2/ACS/allograft bone dowel, Autogenous bone/allograft bone dowel
Keywords: symptomatic 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.

rhBMP-2/ACS/allograft bone dowelDevice
Also called Recombinant human bone morphogenetic protein-2
The rhBMP-2/ACS used in conjunction with an allograft bone dowel.
Autogenous bone/allograft bone dowelProcedure or surgery
Also called Autograft
An allograft bone dowel containing autogenous bone taken from the patient's iliac crest.

Study groups in NCT01494493
Study group	Role	What they receive
rhBMP-2/ACS	Experimental	Not described Receives: Device: rhBMP-2/ACS/allograft bone dowel
Autogenous Bone	Active comparator	Not described Receives: Procedure: Autogenous bone/allograft bone dowel

What is being measured

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

Overall success
A patient will be considered an overall success if all of the following conditions are met:
1. fusion;
2. pain/disability (Oswestry) improvement;
3. maintenance or improvement in neurological status;
4. no serious adverse event classified as implant associated or implant/surgical procedure associated;
5. no additional surgical procedure classified as a "failure."
Measured: 24 month

Secondary outcomes (5)

Disc Height Measurement
Measured: 24 month
General Health Status (SF-36)
Measured: 24 month
Back and Leg Pain Status (Numerical Rating Scale)
Measured: 24 month
Patient Satisfaction
Measured: 24 month
Patient Global Perceived Effect
Measured: 24 month

Timeline

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

Sep 2000Feb 2004

First posted19 Dec 2011 (estimated)
Study startSep 2000
Primary completionFeb 2004
Study completionFeb 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: None (open label)
Enrolment: 85 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01494493
Sponsor's protocol ID: P00-01
Status last verified: May 2023
First submitted: 12 Dec 2011
Last updated: 17 May 2023
Results posted: No
Data monitoring committee: Yes

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?

Official record

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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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All Degenerative Disc Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Investigation of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease
ClinicalTrials.gov ID: NCT01494493
Acronym / sponsor ID: P00-01
Conditions: Degenerative Disc Disease
Keywords: symptomatic degenerative disc disease
Study type: Interventional
Recruitment status: Terminated
Enrolment: 85 participants (actual)
Lead sponsor: Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
Study start: Sep 2000
Primary completion: Feb 2004 (actual)
Study completion: Feb 2004 (actual)
First posted: 19 Dec 2011 (estimated)
Results: Not posted in the source record

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 clinical trial is to evaluate the implant (rhBMP-2/ACS/allograft bone dowel) as a method of facilitating spinal fusion in patients with degenerative disc disease.

Study design

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

Arm	Type	Receives
rhBMP-2/ACS	Experimental	Device: rhBMP-2/ACS/allograft bone dowel
Autogenous Bone	Active comparator	Procedure: Autogenous bone/allograft bone dowel

Who may qualify

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

Key inclusion criteria (14 listed)

Has degenerative disc disease as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc confirmed by patient history ( e.g.,pain [leg, back, or symptoms in the sciatic nerve distribution], function deficit and/or neurological deficit)and radiographic studies ( e.g., CT, MRl, X-Ray, etc.) to include one or more of the following:
Has preoperative Oswestry score > 35.
Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW, 1932.).
Has single-level symptomatic degenerative involvement from L4 to S1.
Is at least 18 years of age, inclusive, at the time of surgery.

Key exclusion criteria (21 listed)

Had previous anterior spinal fusion surgical procedure at the involved level.
Has posterior spinal instrumentation (which will not be removed) stabilizing the involved level or has had a previous posterior lumbar interbody fusion procedure at the involved level.
Has a condition which requires postoperative medications that interfere with fusion, such as steroids or nonsteroidal antiinflammatory drugs (this does not include low dose aspirin for prophylactic anticoagulation or perioperative steroids).
Has osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).

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
rhBMP-2/ACS/allograft bone dowelAlso: Recombinant human bone morphogenetic protein-2The rhBMP-2/ACS used in conjunction with an allograft bone dowel.	Device	rhBMP-2/ACS
Autogenous bone/allograft bone dowelAlso: AutograftAn allograft bone dowel containing autogenous bone taken from the patient's iliac crest.	Procedure or surgery	Autogenous Bone

Primary outcome

Overall success
Time frame: 24 month
A patient will be considered an overall success if all of the following conditions are met: 1. fusion; 2. pain/disability (Oswestry) improvement; 3. maintenance or improvement in neurological status; 4. no serious adverse event classified as implant associated or implant/surgical procedure associated; 5. no additional surgical procedure classified as a "failure."

5 secondary outcomes

Disc Height Measurement
Time frame: 24 month
General Health Status (SF-36)
Time frame: 24 month
Back and Leg Pain Status (Numerical Rating Scale)
Time frame: 24 month
Patient Satisfaction
Time frame: 24 month
Patient Global Perceived Effect
Time frame: 24 month

Results and safety

The study was stopped early. Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.

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.

Questions about this trial

What is this clinical trial studying?

A study testing rhBMP-2/ACS/allograft bone dowel and Autogenous bone/allograft bone dowel in people with Degenerative Disc Disease, run by Medtronic Spinal and Biologics.

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 14 inclusion and 21 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: stopped early, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was stopped early. Results are not available in the source record.

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 (time frame: 24 month). 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 NCT01494493.

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 17 May 2023.