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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000548235
Ethics application status
Approved
Date submitted
6/07/2009
Date registered
7/07/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective, randomised study comparing the use of Actifuse (trademark) Advanced Bone MatriX (ABX) synthetic bone substitute with INFUSE (registered trademark) in patients requiring 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 (registered trademark) on fusion in patients requiring posterolateral instrumented lumbar fusion.
Universal Trial Number (UTN)
Trial acronym
APPRAISE T2 (A Prospective PLF Randomised Actifuse InfuSe Evaluation Trial 2)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Degenerative disc disease that can be treated using Posterolateral Intertransverse Process Fusion and Internal Fixation achieved by pedicle screws and rods. 237164 0
Condition category
Condition code
Musculoskeletal 237487 237487 0 0
Other muscular and skeletal disorders
Surgery 237488 237488 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Posterolateral Intertransverse Process Fusion and Internal Fixation achieved by pedicle screws and rods and bone graft substitute (Actifuse ABX) with the bone graft laid on between the decorticated transverse processes of the spine.
Intervention code [1] 236876 0
Treatment: Devices
Intervention code [2] 236877 0
Treatment: Surgery
Comparator / control treatment
The same fusion procedure using recombinant human bone morphogenetic protein 2 (rhBMP-2) also refrerred to as INFUSE (trademark) as the bone graft substitute.
Control group
Active

Outcomes
Primary outcome [1] 238296 0
Fusion as assessed by Computed Tomography (CT) scan.
Timepoint [1] 238296 0
1 year following procedure
Secondary outcome [1] 244673 0
Clinical outcome measurements including: Pain using Visual Analogue Scores (VAS), Disability Status using Oswestry Low Back Pain Disability Index Questionnaire, Quality of Life using 36 item Short Form Health Survey SF36.
Timepoint [1] 244673 0
1 year following procedure

Eligibility
Key inclusion criteria
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 Magnetic Resonance Imaging (MRI) scan:
a) Modic Changes.
b) High intensity changes in the annulus.
c) Loss of disc height
d) Decreased Hydration of the disc
e) Canal stenosis with or without spondylotic slip.
f) Gross facet joint changes requiring fusion for treatment.
g) Have documented annular pathology by other means (e.g., with discography),
Has a preoperative Oswestry Back Disability Score of 30 or more.
Minimum age
18 Years
Maximum age
80 Years
Gender
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 Dual X-ray Absorptometry (DEXA) scan in cases of doubt). Is pregnant.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237265 0
Commercial sector/Industry
Name [1] 237265 0
ApaTech Ltd
Address [1] 237265 0
370 Centennial Avenue, Elstree, Hertfordshire, WD6 3TJ
Country [1] 237265 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
ApaTech Ltd
Address
370 Centennial Avenue, Elstree, Hertfordshire, WD6 3TJ
Country
United Kingdom
Secondary sponsor category [1] 236750 0
Commercial sector/Industry
Name [1] 236750 0
Perficio Clinical & Regulatory Pty Ltd
Address [1] 236750 0
PO Box 2050, Clovelly, NSW 2031
Country [1] 236750 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29850 0
Address 29850 0
Country 29850 0
Phone 29850 0
Fax 29850 0
Email 29850 0
Contact person for public queries
Name 13097 0
Mr L J Crossley
Address 13097 0
370 Centennial Avenue, Elstree, Hertfordshire, WD6 3TJ
Country 13097 0
United Kingdom
Phone 13097 0
+44 208 731 4640
Fax 13097 0
Email 13097 0
lyndon.crossley@apatech.com
Contact person for scientific queries
Name 4025 0
Mr L J Crossley
Address 4025 0
370 Centennial Avenue, Elstree, Hertfordshire, WD6 3TJ
Country 4025 0
United Kingdom
Phone 4025 0
+44 208 731 4640
Fax 4025 0
Email 4025 0
lyndon.crossley@apatech.com

No information has been provided regarding IPD availability
Summary results
No Results