Degenerative Disc DiseaseAPPRAISET2NCT01018771
Actifuse ABX Versus INFUSE in Posterolateral Instrumented Lumbar Fusion
A study testing Actifuse ABX and INFUSE, plus Mastergraft granules in people with Degenerative Disc Disease, run by Baxter Healthcare Corporation at 1 site in Australia.
Trial summary
This is a prospective randomised study. Primary objective: Evaluation of success rates of Actifuse ABX and INFUSE in achieving bone fusion. Secondary objectives: Assess clinical outcome measurements. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- Actifuse ABX and INFUSE, plus Mastergraft granules
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2009to Dec 2012
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have degenerative disc disease of the lumbar spine as indicated by back pain of discogenic/degenerative origin with or without leg pain and has one or more of the following conditions as documented by Plain X-Rays, CT Scan or MRI Scan:
- Modic changes.
- High intensity changes in the annulus.
- Loss of disc height.
- Decreased hydration of the disc.
- Canal stenosis with or without Spondylotic slip.
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- Gross facet joint changes requiring fusion for treatment.
- Have documented annular pathology by other means. (e.g. with discography).
- Have a preoperative Oswestry Back Disability Score of 30 or more.
- Aged 18 to 75 years and skeletally mature at time of surgery.
- Have not responded to non-operative treatment (e.g. bed rest, physical therapy, medications and/or spinal injections) for a period of six months.
- If of childbearing potential, patient is non-pregnant, non-nursing and agrees not to become pregnant for one year following surgery.
- Is will to and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form.
Who cannot join
- Has had previous failed attempts at fusion surgery at the involved level(s).
- Has a diagnosis of spinal infection tumour or trauma.
- Requires surgery at more than two (2) levels.
- Has osteoporosis (excluding osteopenia) as evidenced on plain X-rays, CT Scans (or DEXA scan in cases of doubt).
- Is pregnant.
- Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse.
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- Has received drugs that may interfere with bone metabolism within two weeks prior to the planned surgery date (e.g. steroids or methotrexate) excluding routine perioperative, non-steroidal anti-inflammatory drugs.
- Has a history of autoimmune disease.
- 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 (device and/or pharmaceutical) within 30 days prior to surgery or such treatment is planned during the 24 months following surgery.
- Has received any previous exposure to any/all BMPs of either human or animal extraction.
- Has a history of allergy to bovine products or a history of anaphylaxis.
- Has a history of any endocrine or metabolic disorder known to affect osteogenesis (e.g. Paget's disease, renal oseodystrophy, Ehlos-Danlos syndrome or Osteogenesis Imperfecta).
- Has any disease that would preclude accurate clinical evaluation (e.g. neuromuscular disease etc).
- Has a primary diagnosis of a spinal disorder other than degenerative disc disease or other conditions as set out in "Inclusions" above at the involved level(s).
- Has a condition that requires postoperative medications that interfere with fusion, such as steroids or prolonged use of non-steroidal anti-inflammatory drugs, excluding routine perioperative, non-steroidal anti-inflammatory drugs. This does not include low dose aspirin for prophylactic anticoagulation.
- Has overt or active bacterial infection, local or systemic and/or a potential for bacteremia.
- Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
- Has a documented metal allergy or intolerance to titanium alloy or cobalt-chrome-molybdenum alloy.
- Who, in the opinion of the Principal Investigator or Co-Investigators, is intellectually unable to co-operate with the study.
- Has chronic or acute renal and/or hepatic failure or prior history of renal or hepatic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomised Study Comparing the Use of Actifuse (Trademark) Advanced Bone Matrix (ABX) Synthetic Bone Substitute With INFUSE (Trademark) on Fusion in Patients Requiring Posterolateral Instrumented Lumbar Fusion
This is a prospective randomised study.
Primary objective: Evaluation of success rates of Actifuse ABX and INFUSE in achieving bone fusion.
Secondary objectives: Assess clinical outcome measurements.
- Conditions
- Degenerative Disc Disease
- Being tested
- Actifuse ABX, INFUSE, plus Mastergraft granules
- Keywords
- actifuse, INFUSE, InductOs, DDD, Degenerative disc disease, PLF, posterolateral lumbar fusion, bone substitute, bone graft, synthetic bone substitute, spinal surgery
- 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.
Actifuse ABXProcedure or surgery
bone graft to be used in posterolateral instrumented lumbar fusion
INFUSE, plus Mastergraft granulesProcedure or surgery
bone graft to be used in posterolateral instrumented lumbar fusion
| Study group | Role | What they receive |
|---|---|---|
| Actifuse ABX | Experimental | Actifuse ABX bone substitute Receives: Procedure: Actifuse ABX |
| INFUSE, plus Mastergraft granules | Active comparator | Not described Receives: Procedure: INFUSE, plus Mastergraft granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion, defined as evidence of bridging trabecular bone present at 1 year
Measured: 1 year
Secondary outcomes (1)
Improvement in the following clinical outcomes measurements: Pain/Disability as measured by Oswestry Lower Back Pain Questionnaire; Quality of Life as measured by Short Form Health Survey (SF36)and Neurological Status
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2012
- Study completionDec 2012
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Apatech, Inc.
- Responsible party
- Sponsor
- Investigators
- Huub Kruewel, Ph.D, Study director, Director, Medical Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018771
- Sponsor's protocol ID
- CIP0803PLF
- Other IDs
- ACTRN12609000548235
- Acronym
- APPRAISET2
- Status last verified
- Apr 2017
- First submitted
- 24 Nov 2009
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised Study Comparing the Use of Actifuse (Trademark) Advanced Bone Matrix (ABX) Synthetic Bone Substitute With INFUSE (Trademark) on Fusion in Patients Requiring Posterolateral Instrumented Lumbar Fusion
- ClinicalTrials.gov ID
- NCT01018771
- Acronym / sponsor ID
- APPRAISET2 / CIP0803PLF
- Conditions
- Degenerative Disc Disease
- Keywords
- actifuse, INFUSE, InductOs, DDD, Degenerative disc disease, PLF, posterolateral lumbar fusion, bone substitute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Apatech, Inc.
- Study start
- Jul 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 25 Nov 2009 (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.
This is a prospective randomised study.
Primary objective: Evaluation of success rates of Actifuse ABX and INFUSE in achieving bone fusion.
Secondary objectives: Assess clinical outcome measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Actifuse ABX | Experimental | Procedure: Actifuse ABXActifuse ABX bone substitute |
| INFUSE, plus Mastergraft granules | Active comparator | Procedure: INFUSE, plus Mastergraft granules |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Have degenerative disc disease of the lumbar spine as indicated by back pain of discogenic/degenerative origin with or without leg pain and has one or more of the following conditions as documented by Plain X-Rays, CT Scan or MRI Scan:
- Have a preoperative Oswestry Back Disability Score of 30 or more.
- Aged 18 to 75 years and skeletally mature at time of surgery.
- Have not responded to non-operative treatment (e.g. bed rest, physical therapy, medications and/or spinal injections) for a period of six months.
- If of childbearing potential, patient is non-pregnant, non-nursing and agrees not to become pregnant for one year following surgery.
Key exclusion criteria (22 listed)
- Has had previous failed attempts at fusion surgery at the involved level(s).
- Has a diagnosis of spinal infection tumour or trauma.
- Requires surgery at more than two (2) levels.
- Has osteoporosis (excluding osteopenia) as evidenced on plain X-rays, CT Scans (or DEXA scan in cases of doubt).
- Is pregnant.
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 |
|---|---|---|
| Actifuse ABXbone graft to be used in posterolateral instrumented lumbar fusion | Procedure or surgery | Actifuse ABX |
| INFUSE, plus Mastergraft granulesbone graft to be used in posterolateral instrumented lumbar fusion | Procedure or surgery | INFUSE, plus Mastergraft granules |
Primary outcome
Fusion, defined as evidence of bridging trabecular bone present at 1 year
Time frame: 1 year
1 secondary outcome
Improvement in the following clinical outcomes measurements: Pain/Disability as measured by Oswestry Lower Back Pain Questionnaire; Quality of Life as measured by Short Form Health Survey (SF36)and Neurological Status
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
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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.
Huub Kruewel, Ph.D study director
Director, Medical Affairs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actifuse ABX and INFUSE, plus Mastergraft granules in people with Degenerative Disc Disease, run by Baxter Healthcare Corporation at 1 site in Australia.
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 13 inclusion and 22 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 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fusion, defined as evidence of bridging trabecular bone present at 1 year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2017.