Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000802909
Ethics application status
Approved
Date submitted
13/04/2020
Date registered
10/08/2020
Date last updated
10/08/2020
Date data sharing statement initially provided
10/08/2020
Date results information initially provided
10/08/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Analysis of Patient Outcomes following Platelet Rich Plasma Treatment
for Joint Osteoarthritis
Scientific title
Analysis of Patient Outcomes following Platelet Rich Plasma Treatment
for Joint Osteoarthritis
Secondary ID [1] 300994 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthiritis 317037 0
Musculoskeletal pain 317038 0
Condition category
Condition code
Musculoskeletal 315199 315199 0 0
Osteoarthritis
Musculoskeletal 315200 315200 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The observational study assessed the effectivenes of Platelet Rich Plasma (PRP) on Non-specific Ankle Pain and Knee Osteoarthritis. Pain levels was assessed from baseline (before PRP injection) to 2-3 months after final PRP treatment. This data was collected retrospectively.
In order to prepare a single injection of PRP with supra-physiological platelet concentrations of up to three times normal, 17 mL of blood was collected from the patient’s cubital vein using a 21 G needle to a blood collection tube containing 1 mL of acid citrate, trisodium citrate-22.0g/L and citric acid-8.0g/L. Thus, two PRP tubes were produced, each containing 8.5 mL of blood. the buffy coat and plasma layers (PRP) were collected from the patient’s PRP tubes via an 18 G needle, into a single syringe. The volume of PRP in the syringe ranged from 7-8 mL.
Knee- 7-8ml PRP injection, average of 4 treatments across 6 weeks
Ankle joint- 7-8ml PRP injection, average of 4 treatments across 6 weeks
Ankle Ligament- 5ml PRP injection, average of 3 treatments across 4 weeks
The PRP treatment was administered by a number of general practitioners specialising in musculoskeletal conditions who have been trained in PRP treatment. Administeration was conducted at a number of medical clinics. Pain assessment was carried out 2-3 months following PRP administration.
Intervention code [1] 317320 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323458 0
Pain, assessed by the visual analogue scale consists of an 11 point scale with 0 being 'no pain at all' and 10 being ‘worst imaginable pain.’
Timepoint [1] 323458 0
Baseline (before PRP injection) and within 2-3 months following the participant’s final PRP treatment. The date of the final PRP treatment was noted for each participant and was used as a guide to determine when the 2-3 month follow up would happen.
Secondary outcome [1] 382006 0
Pain was the main outcome measure, no secondary measures
Timepoint [1] 382006 0
None

Eligibility
Key inclusion criteria
• Were 18 years and over of age.
• They received PRP treatment for pain and/or loss of function due to knee OA.
• They received PRP treatment for pain and/or loss of function due to pes anserine bursitis.
• They received PRP treatment for pain and/or loss of function due to ankle osteoarthritis.
• They received PRP treatment for pain and/or loss of function due to an anterior talofibular ligament sprain.
• They received PRP treatment for pain and/or loss of function due to an anterior talofibular ligament tear.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Were under 18 years of age.
• Were immuno-compromised.
• Had a current malignancy.
• Had a current or recent joint infection.
• Had taken non-steroidal anti-inflammatory drugs 2 days before treatment or corticosteroids during the three weeks before treatment.
• Were pregnant or breastfeeding.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
A repeated measures t-test of variance was conducted to assess pain score differences between the baseline visit and approximately 10 weeks following the final visit. An analysis of covariance (ANCOVA) was conducted to determine whether there was a difference in the change in pain between knee and ankle treatments. This analysis was used to control for potential continuous confounder variables such as the number of treatments. Potential confounding variables were assessed using the correlation regression analyses generated in the ANCOVA, with covariates included in the ANCOVA only if they had a significant effect (p < 0.05) on the VAS pain scores.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/06/2018
Date of last participant enrolment
Anticipated
Actual
7/06/2018
Date of last data collection
Anticipated
Actual
7/06/2019
Sample size
Target
1078
Accrual to date
Final
1078
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 29989 0
3144 - Malvern

Funding & Sponsors
Funding source category [1] 305440 0
Other
Name [1] 305440 0
surecell Medical Clinic
Country [1] 305440 0
Australia
Primary sponsor type
Other
Name
Surecell Medical Clinic
Address
1291 Malvern Road, Malvern VIC 3144
Country
Australia
Secondary sponsor category [1] 305837 0
None
Name [1] 305837 0
Address [1] 305837 0
Country [1] 305837 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305758 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 305758 0
21 Burwood rd, Hawthorn, Victoria, 3122
Ethics committee country [1] 305758 0
Australia
Date submitted for ethics approval [1] 305758 0
07/06/2018
Approval date [1] 305758 0
07/06/2018
Ethics approval number [1] 305758 0
0046E_2018

Summary
Brief summary
Platelet Rich Plasma (PRP) is a preparation of autologous plasma enriched with a platelet concentration above that normally contained in whole blood. PRP can be used to treat orthopaedic conditions including osteoarthritis, bursitis, muscle strain, tendinitis, and tendinosis.
The aim of the present study was to compare the response of knees and ankles following platelet rich plasma (PRP) treatment. It was hypothesised that the application of PRP treatment to non-specific ankle pain cases would result in a significant reduction in self-reported pain.
Trial website
Trial related presentations / publications
Public notes
The participants consented to have their collected data analysed for research purposes. Ethics approval was obtained to analyse the collected study data retrospectively which is when data collection commenced.

Contacts
Principal investigator
Name 101494 0
Mr Nikolaj Travica
Address 101494 0
National Institute of Integrative Medicine (NIIM), 21 Burwood rd, Hawthorn Victoria, 3122
Country 101494 0
Australia
Phone 101494 0
+61 3 9912 9544
Fax 101494 0
Email 101494 0
ntravica@niim.com.au
Contact person for public queries
Name 101495 0
Mr Nikolaj Travica
Address 101495 0
National Institute of Integrative Medicine (NIIM), 21 Burwood rd, Hawthorn Victoria, 3122
Country 101495 0
Australia
Phone 101495 0
+61 3 9912 9544
Fax 101495 0
Email 101495 0
ntravica@niim.com.au
Contact person for scientific queries
Name 101496 0
Mr Nikolaj Travica
Address 101496 0
National Institute of Integrative Medicine (NIIM), 21 Burwood rd, Hawthorn Victoria, 3122
Country 101496 0
Australia
Phone 101496 0
+61 3 9912 9544
Fax 101496 0
Email 101496 0
ntravica@niim.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7609Study protocol    379609-(Uploaded-13-04-2020-22-18-23)-Study-related document.docx
7610Ethical approval    379609-(Uploaded-13-04-2020-22-19-05)-Study-related document.pdf



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.