Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000672853
Ethics application status
Approved
Date submitted
5/06/2012
Date registered
22/06/2012
Date last updated
3/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
HiQCell TM Joint Registry in patients with osteoarthritis following the HiQCellTM procedure.
(This is not a clinical trial - patients undergoing the treatment as prescribed by their specialist are followed up post-procedure.)
Scientific title
A Registry of Autologous Non-Expanded Adipose Derived Stem Cells (HiQCellTM) in the Treatment of Osteoarthritis to determine prevalence of joint infections.
Secondary ID [1] 280480 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 286460 0
Condition category
Condition code
Musculoskeletal 286717 286717 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational registry. All patients referred to one of Regeneus’ HiQCellTM Specialist Centres who have OA in one or more joints who fulfil the inclusion and exclusion criteria are eligible for inclusion. Long-term (5 year) follow up outcomes will be assessed using patient and clinician reported standard questionnaires.
Intervention code [1] 284846 0
Not applicable
Comparator / control treatment
No comparator / control treatment as this is an Observational Study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287112 0
Confirmed Joint Infections

This will be assessed at the follow up visits with questions from the patients medical specialist on a Post-Op Experience Questionnaire
Timepoint [1] 287112 0
Post-procedure: 2 weeks, 6 months, 12 months, annually
Primary outcome [2] 287113 0
Reduction in Pain This will be assessed at baseline (prior to having the HiQCell procedure) and at the follow up visits using validated questionnaires - AQoL, KOOS and NRS
Timepoint [2] 287113 0
Post-procedure: 2 weeks, 6 months, 12 months, annually
Primary outcome [3] 287114 0
Impact on Quality of Life This will be assessed at baseline (prior to having the HiQCell procedure) and at the follow up visits with the AQoL and KOOS
Timepoint [3] 287114 0
Post-procedure: 2 weeks, 6 months, 12 months, annually
Secondary outcome [1] 297395 0
Changes in Analgesic and Anti-inflammatory Use

This will be assessed at baseline & at follow up visits using data collected from the registry on use of Analgesic & Anti-Inflammatory Medication
Timepoint [1] 297395 0
Post-procedure: 2 weeks, 6 months, 12 months, annually
Secondary outcome [2] 297396 0
Change in Sleep Habits

This will be assessed at baseline & at follow up visits using data collected from the registry on night-time sleeping habits
Timepoint [2] 297396 0
Post-procedure: 2 weeks, 6 months, 12 months, annually
Secondary outcome [3] 297397 0
Magnetic Resonance Imaging in a subset of knee osteoarthritis

This will be assessed at baseline & at follow up visits using standard radiographic sequences for knees on an MRI scan
Timepoint [3] 297397 0
Post-procedure: 6months and 12 months

Eligibility
Key inclusion criteria
Received a HiQCellTM procedure for joint osteoarthritis
Grade 2, 3 or early Grade 4 Osteoarthritis
Concurrent disease medically stable
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Established Grade 4 osteoarthritis

Major mal-alignment

Large osteophytes

Bone on Bone

Obese

Known allergies/ hypersensitivities to local anaesthetics or antibiotics

Anti-coagulant use (as below) that cannot be stopped or bleeding disorders (no use of Warfarin, Aspirin, Vitamin E, fish oil or anti-inflammatory medications 10 days before treatment)

Immunosuppression

Pregnancy

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2012
Actual
31/03/2011
Date of last participant enrolment
Anticipated
Actual
30/05/2014
Date of last data collection
Anticipated
Actual
30/05/2015
Sample size
Target
1000
Accrual to date
Final
403
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 1451 0
John Flynn - Gold Coast Private Hospital - Tugun
Recruitment hospital [2] 1452 0
The Surgery Centre-Hurstville - Hurstville
Recruitment hospital [3] 1453 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [4] 4033 0
Linley Clinic - Canterbury
Recruitment postcode(s) [1] 7286 0
2113 - Macquarie Park
Recruitment postcode(s) [2] 7285 0
2220 - Hurstville
Recruitment postcode(s) [3] 9947 0
3126 - Canterbury
Recruitment postcode(s) [4] 7284 0
4224 - Tugun

Funding & Sponsors
Funding source category [1] 285237 0
Commercial sector/Industry
Name [1] 285237 0
Regeneus Ltd
Country [1] 285237 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Regeneus Ltd
Address
77 Ridge St
Gordon NSW 2072
Country
Australia
Secondary sponsor category [1] 284103 0
None
Name [1] 284103 0
Address [1] 284103 0
Country [1] 284103 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287402 0
Bellberry Ltd
Ethics committee address [1] 287402 0
Ethics committee country [1] 287402 0
Australia
Date submitted for ethics approval [1] 287402 0
Approval date [1] 287402 0
30/05/2012
Ethics approval number [1] 287402 0

Summary
Brief summary
This is an observational registry to assess the long-term safety and efficacy of the HiQCell procedure in patients who have been prescribed the procedure to treat joint arthritis following a registered medical specialist consultation.
Trial website
Trial related presentations / publications
Interim data analyses are conducted by the sponsor and made publicly available on the sponsor's website at www.regeneus.com.au. The most recent report, titled 'The HiQCell Joint Registry Interim Report', covers data as of 31-Oct-2014.
Public notes

Contacts
Principal investigator
Name 34171 0
Prof Jeganath Krishnan
Address 34171 0
Orthopaedics SA
Flinders Private Hospital
1 Flinders Drive
Bedford Park SA 5042
Country 34171 0
Australia
Phone 34171 0
+61 8 82044289
Fax 34171 0
Email 34171 0
sylvia.mcandrew@flinders.edu.au
Contact person for public queries
Name 17418 0
Janet Wilson
Address 17418 0
Regeneus Ltd
25 Bridge Street
Pymble NSW 2073
Country 17418 0
Australia
Phone 17418 0
61 2 9499 8010
Fax 17418 0
Email 17418 0
info@regeneus.com.au
Contact person for scientific queries
Name 8346 0
Clinical Research Director - Janet Wilson
Address 8346 0
Regeneus Ltd
25 Bridge Street
Pymble NSW 2073
Country 8346 0
Australia
Phone 8346 0
+ 61 2 9499 8010
Fax 8346 0
Email 8346 0
info@regeneus.com.au

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.