Degenerative Disc DiseaseAPPRAISET1NCT01013389
Actifuse ABX Versus INFUSE in Posterolateral Instrumented Lumbar Fusion (PLIF) With Interbody Fusion
A study testing Actifuse ABX and INFUSE, plus master granules (MGG) in people with Degenerative Disc Disease, run by Baxter Healthcare Corporation at 2 sites in 2 countries.
Trial summary
The primary objective of this clinical trial is to evaluate the success rates of Actifuse ABX and INFUSE in achieving bone fusion. The secondary objective of this clinical trial is to assess clinical outcome measurements. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- Actifuse ABX and INFUSE, plus master granules (MGG)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2007to 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has 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).
- Has a preoperative Oswestry Back Disability Score of 30 or more.
- Aged 18 to 75 years and skeletally mature at time of surgery.
- Has 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 willing 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 general 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.
- Is, in the opinion of the Principal Investigator or Co-Investigators, 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
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Prospective, Randomised Study Comparing the Use of Actifuse (Trademark)ABX Synthetic Bone Substitute With INFUSE (Registrered Trademark) in Patients Requiring Posterolateral Instrumented Lumbar Fusion With Interbody Fusion
The primary objective of this clinical trial is to evaluate the success rates of Actifuse ABX and INFUSE in achieving bone fusion.
The secondary objective of this clinical trial is to assess clinical outcome measurements.
- Conditions
- Degenerative Disc Disease
- Being tested
- Actifuse ABX, INFUSE, plus master granules (MGG)
- Keywords
- actifuse, INFUSE, InductOs, DDD, degenerative disk disease, PLIF, PITF, PLF, poterolateral lumber fusion, Bone substitute, bone graft, synthetic bone substitute
- 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 substitute used for posterolateral instrumented lumbar fusion with interbody fusion
INFUSE, plus master granules (MGG)Procedure or surgery
bone substitute in posterolateral instrumented lumbar fusion with interbody fusion
| Study group | Role | What they receive |
|---|---|---|
| Actifuse ABX | Experimental | Actifuse ABX bone substitute Receives: Procedure: Actifuse ABX |
| INFUSE, plus master granules (MGG) | Active comparator | synthetic bone substitute used in posterolateral instrumented lumber fusion with interbody fusion Receives: Procedure: INFUSE, plus master granules (MGG) |
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 as assessed by CT scan as well as a determination of no motion as assessed by plain radiographs.
Measured: 1 year
Secondary outcomes (1)
Improvement clinical outcomes measurements compared to pre-opscores: 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 posted13 Nov 2009 (estimated)
- Study startJun 2007
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Apatech, Inc.
- Responsible party
- Sponsor
- Investigators
- Huub Kreuwel, Ph.D, Study director, Director, Medical Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01013389
- Sponsor's protocol ID
- CIP0702PLF
- Other IDs
- ACTRN12609000527268, EudraCT Number: 2009-012672-27
- Acronym
- APPRAISET1
- Status last verified
- Apr 2017
- First submitted
- 10 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)ABX Synthetic Bone Substitute With INFUSE (Registrered Trademark) in Patients Requiring Posterolateral Instrumented Lumbar Fusion With Interbody Fusion
- ClinicalTrials.gov ID
- NCT01013389
- Acronym / sponsor ID
- APPRAISET1 / CIP0702PLF
- Conditions
- Degenerative Disc Disease
- Keywords
- actifuse, INFUSE, InductOs, DDD, degenerative disk disease, PLIF, PITF, PLF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Apatech, Inc.
- Study start
- Jun 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 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.
The primary objective of this clinical trial is to evaluate the success rates of Actifuse ABX and INFUSE in achieving bone fusion.
The secondary objective of this clinical trial is to 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 master granules (MGG) | Active comparator | Procedure: INFUSE, plus master granules (MGG)synthetic bone substitute used in posterolateral instrumented lumber fusion with interbody fusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Has 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:
- Has a preoperative Oswestry Back Disability Score of 30 or more.
- Aged 18 to 75 years and skeletally mature at time of surgery.
- Has 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 substitute used for posterolateral instrumented lumbar fusion with interbody fusion | Procedure or surgery | Actifuse ABX |
| INFUSE, plus master granules (MGG)bone substitute in posterolateral instrumented lumbar fusion with interbody fusion | Procedure or surgery | INFUSE, plus master granules (MGG) |
Primary outcome
Fusion, defined as evidence of bridging trabecular bone present at 1 year as assessed by CT scan as well as a determination of no motion as assessed by plain radiographs.
Time frame: 1 year
1 secondary outcome
Improvement clinical outcomes measurements compared to pre-opscores: 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 Kreuwel, Ph.D study director
Director, Medical Affairs
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actifuse ABX and INFUSE, plus master granules (MGG) in people with Degenerative Disc Disease, run by Baxter Healthcare Corporation at 2 sites in 2 countries.
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 2 sites in Australia, Netherlands. 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 as assessed by CT scan as well as a determination of no motion as assessed by plain radiographs. (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.