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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01018771




Registration number
NCT01018771
Ethics application status
Date submitted
24/11/2009
Date registered
25/11/2009
Date last updated
5/04/2017

Titles & IDs
Public title
Actifuse ABX Versus INFUSE in Posterolateral Instrumented Lumbar Fusion
Scientific 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
Secondary ID [1] 0 0
ACTRN12609000548235
Secondary ID [2] 0 0
CIP0803PLF
Universal Trial Number (UTN)
Trial acronym
APPRAISET2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Degenerative Disc Disease 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Actifuse ABX
Treatment: Surgery - INFUSE, plus Mastergraft granules

Experimental: Actifuse ABX - Actifuse ABX bone substitute

Active Comparator: INFUSE, plus Mastergraft granules -


Treatment: Surgery: Actifuse ABX
bone graft to be used in posterolateral instrumented lumbar fusion

Treatment: Surgery: INFUSE, plus Mastergraft granules
bone graft to be used in posterolateral instrumented lumbar fusion
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Fusion, defined as evidence of bridging trabecular bone present at 1 year
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
1 year

Eligibility
Key inclusion criteria
- 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.

- 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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.

- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2012
Sample size
Target
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Moloney & Associates - Wollongong
Recruitment postcode(s) [1] 0 0
NSW2522 - Wollongong

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Baxter Healthcare Corporation
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Apatech, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01018771
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Huub Kruewel, Ph.D
Address 0 0
Director, Medical Affairs
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01018771