Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000527268
Ethics application status
Approved
Date submitted
26/06/2009
Date registered
2/07/2009
Date last updated
2/07/2009
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 with interbody fusion
Scientific title
A prospective, randomised study comparing the use of Actifus (trademark) Advanced Bone MatriX (ABX) synthetic bone substitute with INFUSE (registered trademark) on fusion in patients requiring posterolateral instrumented lumbar fusion with interbody fusion.
Universal Trial Number (UTN)
Trial acronym
APPRAISE T1 (A Prospective PLF Randomised Actifuse InfuSe Evaluation Trial 1)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Degenerative disc disease that can be treated using Posterior Lumbar Interbody Fusion with Posterolateral Intertransverse Process Fusion and Internal Fixation achieved by pedicle screws and rods. 237106 0
Condition category
Condition code
Musculoskeletal 237434 237434 0 0
Other muscular and skeletal disorders
Surgery 237448 237448 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Posterior Lumbar Interbody Fusion with Posterolateral Intertransverse Process Fusion and Internal Fixation achieved by pedicle screws and rods and bone graft substitute (Actifuse ABX), with the bone graft substitute laid on between the decorticated transverse processes of the spine.
Intervention code [1] 236825 0
Treatment: Devices
Intervention code [2] 236843 0
Treatment: Surgery
Comparator / control treatment
The same fusion procedure using recombinant human bone morphogenetic protein 2 (rhBMP-2) also referred to as INFUSE (trademark) as the bone graft substitute
Control group
Active

Outcomes
Primary outcome [1] 238231 0
Fusion as assessed by Computed Tomography (CT) scan
Timepoint [1] 238231 0
1 year following procedure
Secondary outcome [1] 244564 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] 244564 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
75 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 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
27/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 1856 0
Netherlands
State/province [1] 1856 0

Funding & Sponsors
Funding source category [1] 237217 0
Commercial sector/Industry
Name [1] 237217 0
ApaTech Ltd
Country [1] 237217 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] 4709 0
Commercial sector/Industry
Name [1] 4709 0
Perficio Clinical & Regulatory Pty Ltd
Address [1] 4709 0
PO Box 2050
Clovelly NSW 2031
Country [1] 4709 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 29802 0
Address 29802 0
Country 29802 0
Phone 29802 0
Fax 29802 0
Email 29802 0
Contact person for public queries
Name 13049 0
Mr L Crossley
Address 13049 0
ApaTech Ltd
370 Centennial Avenue
Elstree
Hertfordshire
WD6 3TJ
Country 13049 0
United Kingdom
Phone 13049 0
+44 208 7314640
Fax 13049 0
Email 13049 0
[email protected]
Contact person for scientific queries
Name 3977 0
Mr L Crossley
Address 3977 0
ApaTech Ltd
370 Centennial Avenue
Elstree
Hertfordshire
WD6 3TJ
Country 3977 0
United Kingdom
Phone 3977 0
+44 208 731 4640
Fax 3977 0
Email 3977 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.