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Trial registered on ANZCTR


Registration number
ACTRN12611000651987
Ethics application status
Approved
Date submitted
24/06/2011
Date registered
24/06/2011
Date last updated
2/06/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Platelet rich plasma injection for treatment of osteoarthritis
Scientific title
The effects of intra-articular injection of platelet rich plasma on pain and function in patients with knee osteoarthritis: A randomised controlled trial.
Secondary ID [1] 262468 0
nil
Universal Trial Number (UTN)
U1111-1122-4264
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis 268160 0
osteochondral defect 268161 0
Condition category
Condition code
Musculoskeletal 268293 268293 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To make the platelet rich plasma (PRP), 20 ml of the patient’s blood will be collected and centrifuged at 100g for 5 minutes. The plasma and buffy coat will be drawn from the top, placed in a sterile tube and activated using low-level light irradiation. The activated PRP will then be injected into the patient's symptomatic knee under ultrasound guidance.

Patients will receive three injections each of 5ml platelet-rich plasma one week apart. Time-points for injections: 1) initial injection, 2) one week following initial injection and 3) two weeks following initial injection. This results in a total treatment duration of two weeks.
Intervention code [1] 266826 0
Treatment: Other
Comparator / control treatment
Three injections each of 2ml (16 mg) of Hylan G-F 20 one week apart. Time-points for injections: 1) initial injection, 2) one week following initial injection and 3) two weeks following initial injection. This results in a total treatment duration of two weeks.
Control group
Active

Outcomes
Primary outcome [1] 269022 0
Pain measured using 100mm Visual Analogue Score (VAS)
Timepoint [1] 269022 0
Baseline, daily for the first two weeks, weekly for the subsequent two weeks and four and eight weeks, and six and 12 months, following the final injection
Primary outcome [2] 269023 0
Knee Injury and Osteoarthritis Outcome Score
Timepoint [2] 269023 0
Baseline, four and eight weeks, and six and 12 months, following the final injection
Secondary outcome [1] 276839 0
Maximum single leg hop for distance. Participant hops as far as possible and the distance (in cm) from the toe in starting position to heel in landing position is measured by the researcher using a tape measure. The best of three hops is recorded.
Timepoint [1] 276839 0
Baseline, four and eight weeks, and six and 12 months, following the final injection
Secondary outcome [2] 276840 0
Maximum number of knee bends performed in 30 seconds. Participant bends the knee without bending forward from the hip (until they cannot see a line along the toes, equivalent to about 30 degrees of knee flexion) as many times as possible in 30 seconds. Time is recorded using a stopwatch and number of bends are counted by the researcher.
Timepoint [2] 276840 0
Baseline, four and eight weeks, and six and 12 months, following the final injection

Eligibility
Key inclusion criteria
A diagnosis of OA assessed via the International Cartilage Repair Society guidelines and a visual analogue pain score of greater than 50 out of 100
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No systemic or inflammatory joint disease, no history of crystalline or neuropathic arthropathy, no cancer or other tumour-like lesions, not pregnant or lactating, not drug abusing, no other intra articular lesion in the previous six months, no allergy to any test substance and not immunosuppressed

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)
Recruited via a sports medicine clinic and provided with a full medical examination and assessment of the affected knee joint to determine study eligibility. Eligible participants will be allocated to either the control or intervention group by an independent clinic staff member using a central concealed computer randomisation process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order concealed allocation of participants into either the control or intervention group will be performed by simple randomisation using a randomisation table created by computer software (i.e., computerised sequence generation). There will be no stratified allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/06/2011
Actual
28/07/2011
Date of last participant enrolment
Anticipated
Actual
5/08/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267296 0
Self funded/Unfunded
Name [1] 267296 0
Country [1] 267296 0
Primary sponsor type
Individual
Name
Kade Paterson
Address
Australian Catholic University, 115 Victoria Pde, Fitzroy VIC 3095
Country
Australia
Secondary sponsor category [1] 266364 0
Individual
Name [1] 266364 0
Dan Bates
Address [1] 266364 0
Lakeside Sports Medicine Centre, Melbourne Sports and Aquatic Centre, Aughtie Drive, Albert Park, VIC 3206
Country [1] 266364 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269291 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 269291 0
Australian Catholic University, Level 5, 250 Victoria Parade, Fitzroy VIC 3065
Ethics committee country [1] 269291 0
Australia
Date submitted for ethics approval [1] 269291 0
02/02/2011
Approval date [1] 269291 0
31/05/2011
Ethics approval number [1] 269291 0
V2011 09

Summary
Brief summary
Osteoarthritis (OA) is a progressive degenerative disease characterised by loss or damage of the cartilage surface of joints, resulting in pain and disability. Unitl recently, management of mild to moderate OA has been limited to symptomatic relief with analgesia or anti-inflammatory medications, viscosupplementation and exercise therapy, and in extreme cases joint replacement surgery.

An emerging treatment for soft tissue healing and bone mineralisation is platelet rich plasma (PRP) injection. In addition to clotting functions, activated platelets have been found to contain growth factors, cytokines and protiens responsible for promotion of tissue regeneration and healing. Injection of PRP solution to joints during surgical procedures have demonstrated positive effects on healing, pain and function post-operatively. However, to our knowledge, there are limited ramdomised controlled studies evaluating the effect of a less invasive technique of intra-articular injection of PRP. Therefore, this double blinded study aims to assess the changes in pain, activity levels and lower extremity functional ability of patients with mild to moderate OA following intra-articular PRP injection compared to usual treatment of Hylan G-F 20 (SYNVISC).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32789 0
Dr Kade Paterson
Address 32789 0
Centre for Health, Exercise and Sports Medicine
Department of Physiotherapy, Melbourne School of Health Sciences
The University of Melbourne, Victoria, 3010
AUSTRALIA
Country 32789 0
Australia
Phone 32789 0
+61 3 8344 0425
Fax 32789 0
Email 32789 0
[email protected]
Contact person for public queries
Name 16036 0
Kade Paterson
Address 16036 0
Centre for Health, Exercise and Sports Medicine
Department of Physiotherapy, Melbourne School of Health Sciences
The University of Melbourne, Victoria, 3010
AUSTRALIA
Country 16036 0
Australia
Phone 16036 0
+61 3 8344 0425
Fax 16036 0
+61 3 8344 3771
Email 16036 0
[email protected]
Contact person for scientific queries
Name 6964 0
Kade Paterson
Address 6964 0
Centre for Health, Exercise and Sports Medicine
Department of Physiotherapy, Melbourne School of Health Sciences
The University of Melbourne, Victoria, 3010
AUSTRALIA
Country 6964 0
Australia
Phone 6964 0
+61 3 8344 0425
Fax 6964 0
+61 3 8344 3771
Email 6964 0
[email protected]

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