Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001162303
Ethics application status
Approved
Date submitted
3/08/2017
Date registered
8/08/2017
Date last updated
10/07/2020
Date data sharing statement initially provided
30/07/2019
Date results information initially provided
30/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of blood injections (Platelet Rich Plasma) on symptomatic early worn out knees.
Scientific title
Randomised controlled trial assessing the effectiveness of platelet rich plasma (PRP) injections on symptomatic early osteoarthritis of the knee
Secondary ID [1] 292385 0
Nil Known
Universal Trial Number (UTN)
U1111-1198-9866
Trial acronym
PEAK Trial

(PRP treatment in Early osteoArthtris Knee)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 303948 0
Condition category
Condition code
Musculoskeletal 303595 303595 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Injection of Platelet Rich Plasma into knee
3 injections 1 week apart.
• Group 1 receives 3 placebo injections (Normal Saline).
• Group 2 receives one PRP injection followed by two placebo injections.
• Group 3 receives 3 PRP injections.

Irrespective of which group a patient is randomised to, they will require a blood draw of 20mL at each of the first 3 appointments to ensure patients are blinded to the treatment. If they are to receive a PRP injection, this will be processed and injected. If they are to receive a saline injection, the blood will be appropriately discarded. The blood draw and preparation will be performed by a doctor who is an unblinded member of the research team. In order to completely blind the patients to their treatment, a shield will be applied so they cannot see what product is being injected.
The blood for PRP is drawn up in a special syringe which is then placed in a centrifuge. The platelet rich plasma component is kept and the other layers discarded. The injection into the knee occurs immediately after centrifuge process (no storage required). .
Intervention code [1] 298778 0
Treatment: Other
Comparator / control treatment
Injection of Saline into knee
3 injections 1 week apart.
• Group 1 receives 3 placebo injections (Normal Saline).
• Group 2 receives one PRP injection followed by two placebo injections.
• Group 3 receives 3 PRP injections.

Irrespective of which group a patient is randomised to, they will require a blood draw of 20mL at each of the first 3 appointments to ensure patients are blinded to the treatment. If they are to receive a PRP injection, this will be processed and injected. If they are to receive a saline injection, the blood will be appropriately discarded. The blood draw and preparation will be performed by a doctor who is an unblinded member of the research team. In order to completely blind the patients to their treatment, a shield will be applied so they cannot see what product is being injected
Control group
Placebo

Outcomes
Primary outcome [1] 302958 0
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Timepoint [1] 302958 0
6 weeks, 3 months, 6 months and 12 months (primary timepoint) following the intervention
Primary outcome [2] 302983 0
EQ-5D
Timepoint [2] 302983 0
6 weeks, 3 months, 6 months and 12 months (primary timepoint) following the intervention
Secondary outcome [1] 337564 0
- Visual analogue scale for pain
Timepoint [1] 337564 0
6 weeks, 3 months, 6 months and 12 months following the intervention
Secondary outcome [2] 337620 0
- Patient Satisfaction with injections – Likert scale
Timepoint [2] 337620 0
6 weeks, 3 months, 6 months and 12 months following the intervention
Secondary outcome [3] 337621 0
- Would you have the injection again – Likert scale
Timepoint [3] 337621 0
6 weeks, 3 months, 6 months and 12 months following the intervention

Eligibility
Key inclusion criteria
Patients with early symptomatic primary osteoarthritis of the knee (Kellgren –Lawrence Grades 0-2) and have had 4 months of pain or swelling with radiographic evidence of early tibio-femoral osteoarthritis.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) Previous open knee surgery
ii) Systemic disorders – rheumatological disease, severe cardiovascular disease, haematological disease and infection
iii) Patient on anticoagulants
iv) Advanced knee arthritis Kellgren –Lawrence Grade 3-4.

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary and secondary outcome analysis: In order to compare the relative change in mean outcome measure values in the three treatment groups, the means at baseline and each assessment point will be estimated using repeated measures mixed effects linear regression, corrected for the precise numbers of days at each assessment point (as a random effect). Unadjusted estimates, will be made, and also estimates adjusted for potential confounding variables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2017
Actual
1/09/2017
Date of last participant enrolment
Anticipated
1/06/2018
Actual
1/08/2018
Date of last data collection
Anticipated
31/08/2019
Actual
31/08/2019
Sample size
Target
97
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 8683 0
Launceston General Hospital - Launceston
Recruitment postcode(s) [1] 16794 0
7250 - Launceston

Funding & Sponsors
Funding source category [1] 296936 0
Charities/Societies/Foundations
Name [1] 296936 0
Clifford Craig Medical Research Trust
Country [1] 296936 0
Australia
Primary sponsor type
Individual
Name
Jonathan Mulford
Address
170 St John Street
Launceston
7250

Department Surgery, Launceston General Hospital
Charles Street Launceston 7250
Country
Australia
Secondary sponsor category [1] 295942 0
Hospital
Name [1] 295942 0
Launceston General Hospital
Address [1] 295942 0
Charles Street Launceston
Tasmania
7250
Country [1] 295942 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298141 0
Tasmanian Human Research Ethics Committee
Ethics committee address [1] 298141 0
University of Tasmania
Private Bag 01
Hobart TAS 7001
Ethics committee country [1] 298141 0
Australia
Date submitted for ethics approval [1] 298141 0
03/03/2017
Approval date [1] 298141 0
03/07/2017
Ethics approval number [1] 298141 0

Summary
Brief summary
This project aims to determine the clinical effect of intra-articular multiple PRP injections compared to single PRP injection into the symptomatic early arthritic knee.
The objective is to determine the effectiveness of PRP injections for early knee arthritis and if multiple injections give a better clinical response at up to 12 months following treatment.
This study is designed as a double blinded, randomised placebo-controlled trial with three groups. All groups receive 3 injections 1 week apart.
• Group 1 receives 3 placebo injections (Normal Saline).
• Group 2 receives one PRP injection followed by two placebo injections.
Group 3 receives 3 PRP injections
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76134 0
Dr Jonathan Mulford
Address 76134 0
170 St John Street, Launceston, Tasmania 7250

Launceston General Hospital, Charles Street, Launceston Tasmania 7250
Country 76134 0
Australia
Phone 76134 0
+61 3 63347332
Fax 76134 0
Email 76134 0
jonathanmulford1971@gmail.com
Contact person for public queries
Name 76135 0
Dr Jonathan Mulford
Address 76135 0
170 St John Street
Launceston Tasmania

Launceston General Hospital, Charles Street, Launceston Tasmania 7250
Country 76135 0
Australia
Phone 76135 0
+61 3 63347332
Fax 76135 0
Email 76135 0
tamarvalleyortho@gmail.com
Contact person for scientific queries
Name 76136 0
Dr Jonathan Mulford
Address 76136 0
70 St John Street
Launceston Tasmania

Launceston General Hospital, Charles Street, Launceston Tasmania 7250
Country 76136 0
Australia
Phone 76136 0
+61 3 63347332
Fax 76136 0
Email 76136 0
tamarvalleyortho@gmail.com

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?

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
SourceTitleYear of PublicationDOI
EmbaseThe effectiveness of leucocyte-poor platelet-rich plasma injections on symptomatic early osteoarthritis of the knee: the PEAK randomized controlled trial.2022https://dx.doi.org/10.1302/0301-620X.104B6.BJJ-2021-1109.R2
N.B. These documents automatically identified may not have been verified by the study sponsor.