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Trial registered on ANZCTR


Registration number
ACTRN12619001101178
Ethics application status
Approved
Date submitted
10/07/2019
Date registered
9/08/2019
Date last updated
7/06/2021
Date data sharing statement initially provided
9/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Autologous Protein Solution (APS)– the Biological symptom management of HIP osteoarthritis.
Scientific title
Autologous Protein Solution (APS)– the Biological symptom management of HIP osteoarthritis.
Secondary ID [1] 298645 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip osteoarthritis 313563 0
Condition category
Condition code
Musculoskeletal 311992 311992 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Preparation of the APS is according to the manufacturers instructions - 55 mls of blood is collected in a tube with 5 mls of anti-coagulant. This is centrifuged for 15 minutes at 3200 rpm. 6 mls of PRP is then transferred to the APS cannister and centrifuged again for 2 minutes at 2000 rpm. the resultant APS is a single 3 ml dose.
A single 3 ml injection of Autologous Protein Solution into the hip joint under ultrasound guidance according to standard hip protocols and an aseptic technique. This is done by an experienced Sport and Exercise Medicine Physician or radiologist. A second sample of APS is prepared at the same time and sent to the laboratory for growth factor analysis
Intervention code [1] 314934 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320638 0
Hip pain and function using Modified Harris Hip Score (mHHS)
Timepoint [1] 320638 0
3 months post treatment
Primary outcome [2] 320768 0
Hip pain and function using the Hip Disability and Osteoarthritis Outcome score (HOOS)
Timepoint [2] 320768 0
3 months post treatment
Secondary outcome [1] 372286 0
Hip pain and function using Modified Harris Hip Score (mHHS)
Timepoint [1] 372286 0
12 months post treatment
Secondary outcome [2] 372289 0
Use of breakthrough medication is recorded by the participant as part of the data collection and included in the participant folder
Timepoint [2] 372289 0
3 and 12 months post treatment
Secondary outcome [3] 372291 0
Growth Factor Analysis will be done as an exploratory outcome.
One vial of APS will be analysed for growth factor analysis including anti-inflammatory cytokines involved in osteoarthritis (such as Interleukins and TNF) and anabolic (such as TGF, EGF) and other biological analysis, used as predictors of change. These will be analysed by ELISA techniques.
Timepoint [3] 372291 0
The growth factor concentrations will be analysed as predictors of change at 3 and 12 months post treatment
Secondary outcome [4] 372292 0
Adverse events. Any undesirable clinical occurrence in a subject, whether it is considered to be treatment-related or not, that includes a clinical sign, symptom or condition. Number and type of events will be recorded. Treatment related adverse events are expected to be minor swelling, site tenderness and pain and will be recorded at clinical follow up as specific questions to the participants.
Timepoint [4] 372292 0
1 week, 3 months and 12 months post treatment
Secondary outcome [5] 372771 0
Hip pain and function using the Hip Disability and Osteoarthritis Outcome Score (HOOS)
Timepoint [5] 372771 0
12 months post treatment

Eligibility
Key inclusion criteria
(i) aged>40 years;
(ii) hip pain on most days in the last month;
(iii) X-ray confirmation of the diagnosis of hip osteoarthritis with Kellgren and Lawrence (KL) grade 2-3
(iv) A minimum pain score of 4 on an 11-point numeric rating scale for the last week having ceased all pain medications 5 days prior
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) X-ray confirmation of the diagnosis with Kellgren and Lawrence (KL) grade 1 indicating questionable disease or grade 4 indicating severe disease;
(ii) Hip dysplasia or past Perthes disease or slipped upper femoral epiphysis;
(iii) Radiographic evidence of avascular necrosis
(iv) Hyaluronic acid injection in past 6 months, corticosteroid injection in past 3 months or autologous blood product in the past 12 months;
(v) Hip surgery on the affected side within the past 12 months;
(vi) systemic or inflammatory joint disease;
(vii) history of crystalline or neuropathic arthropathy;
(viii) plan for joint surgery in next 12 months;
(ix) other muscular, joint or neurological condition affecting lower limb function;
(x) needle phobia;
(xi) immunosuppression or acute infective processes;
(xii) cancer or other tumour-like lesions;
(xiii) bleeding disorder or receiving anti-coagulation therapy (at the discretion of the PI);
(xiv) any other medical condition precluding participation in the study including contraindication to MRI such as pregnancy;
(xv) Inability to understand written/spoken English.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All participants will be analysed in the single group in which they were treated. Analysis will be conducted by a biostatistician, with p-values < 0.05 significance. Changes from baseline will be presented at each time point using the mean change and 95% confidence intervals.

An interim analysis will be performed at 3 months on the safety, pain and functional data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/11/2019
Actual
2/12/2019
Date of last participant enrolment
Anticipated
31/01/2020
Actual
4/03/2020
Date of last data collection
Anticipated
31/01/2021
Actual
30/03/2021
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 27175 0
3121 - Richmond North

Funding & Sponsors
Funding source category [1] 303185 0
Charities/Societies/Foundations
Name [1] 303185 0
.Joint Health Institute
Country [1] 303185 0
Australia
Primary sponsor type
University
Name
.University of Melbourne
Address
.Alan Gilbert Building, 161 Barry Street University of Melbourne 3010 VIC Australia
Country
Australia
Secondary sponsor category [1] 303263 0
None
Name [1] 303263 0
Address [1] 303263 0
Country [1] 303263 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303749 0
The University of Melbourne Psychology and Applied Sciences Human Ethics Sub-Committee
Ethics committee address [1] 303749 0
Alan Gilbert Building, Level 5, The University of Melbourne, 161 Barry Street, Victoria 3010 Australia
Ethics committee country [1] 303749 0
Australia
Date submitted for ethics approval [1] 303749 0
18/01/2019
Approval date [1] 303749 0
17/04/2019
Ethics approval number [1] 303749 0
1953629

Summary
Brief summary
Title Autologous Protein Solution (APS) – the Biological symptom management of HIP osteoarthritis.

The hypothesis of this study is that a single injection of APS (nSTRIDE, Zimmer Biomet USA) a product derived from the participant's own blood, is safe and leads to a reduction in hip pain and an improvement in hip function at 3 months which is sustained at 12 months.

This will be tested in 10 participants aged over 40 years with painful hip osteoarthritis and mild to moderately severe structural change on x-rays.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94658 0
A/Prof Mary Jane Fitzpatrick
Address 94658 0
Department of Physiotherapy
Level 7, Alan Gilbert Building, 161 Barry Street
The University of Melbourne, Victoria 3010 Australia
Country 94658 0
Australia
Phone 94658 0
+61 3 9429 6444
Fax 94658 0
+61 3 9421 6144
Email 94658 0
[email protected]
Contact person for public queries
Name 94659 0
Sally Boyd
Address 94659 0
Sports Medicine Professionals
21 Erin Street, Richmond, Victoria 3121
Country 94659 0
Australia
Phone 94659 0
+61 3 9429 6444
Fax 94659 0
+61 3 9421 6144
Email 94659 0
[email protected]
Contact person for scientific queries
Name 94660 0
Sally Boyd
Address 94660 0
Sports Medicine Professionals
21 Erin Street, Richmond, Victoria 3121
Country 94660 0
Australia
Phone 94660 0
+61 3 9429 6444
Fax 94660 0
+61 3 9421 6144
Email 94660 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data relating to PROMs and growth factor analysis
When will data be available (start and end dates)?
Following main results publication available for 3 years post publication
Available to whom?
Case by case basis at the discretion of the CI
Available for what types of analyses?
For inclusion in meta-analysis or other protocols as approved by the CI
How or where can data be obtained?
Access subject to approval by CI via email [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2981Study protocolWill be available in the published supplementary data published with the article  
2982Informed consent form  [email protected]
2983Ethical approval    377900-(Uploaded-10-07-2019-16-33-01)-Study-related document.pdf



Results publications and other study-related documents

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