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Australian Clinical Trials

Clinical Trial Details

Platelet rich plasma for knee osteoarthritis - the RESTORE trial

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Trial Information

Broad Health Condition Musculoskeletal

Specific Health ConditionOsteoarthritis

Trial FocusTreatment

Recruitment Details

Recruitment status

Recruitment State

Royal North Shore Hospital - St Leonards

3010 - University Of Melbourne
2065 - St Leonards

Anticipated date of first participant enrolment20/06/2017

Anticipated date of last participant enrolment31/12/2019

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Trial summary

Knee osteoarthritis is a common condition that affects the cartilage lining of the knee joint and causes pain and stiffness. It is therefore important to find effective treatments that improve people’s symptoms and quality of life, and also slow down the loss of joint cartilage that happens in osteoarthritis. One such therapy that may be effective is platelet-rich plasma (PRP) injections. This treatment involves an injection of the person’s own PRP, which is made from blood taken from their arm and injected into their knee. Blood contains plasma, red blood cells, white blood cells and platelets that release chemicals which can stimulate the healing process. This may give rise to improvements in symptoms and slowing of the disease process.

This study aims to find out whether a series of three PRP injections (one per week for three weeks) into the knee joint is effective in reducing pain and slowing loss of cartilage in the knee joint. To do this, we will compare outcomes over 12 months in a group of patients with knee osteoarthritis who receive three PRP injections and a group who receive three injections of inactive sterile salt injections (saline). 

We will recruit 288 people with mild to moderately severe knee osteoarthritis from the community. Measurements will be taken at baseline, 2 months and 12 months and will comprise questionnaires and magnetic resonance imaging. Participants will be randomly allocated to either the PRP or saline injection group and neither the participant,  nor the injecting doctor or the assessor will know which injection the participant will receive. 


Key inclusion criteria

1)	aged greater than or equal to 50 years;
2)	knee pain on most days in the last month;
3)	tibiofemoral osteophytes on x-ray; and
4)	A minimum pain score of 4 on an 11-point numeric rating scale for the last week.

Minimum age50 Years

GenderBoth males and females

Can Healthy volunteers participate? No

Key exclusion criteria

1)	Kellgren and Lawrence (KL) grade 1 indicating questionable disease or grade 4 indicating severe disease;
2)	predominant lateral tibiofemoral disease;
3)	Hyaluronic acid injection in past 6 months, corticosteroid injection in past 3 months or autologous blood product in the past;
4)	knee surgery on their most painful knee within past 12 months;
5)	systemic or inflammatory joint disease;
6)	history of crystalline or neuropathic arthropathy;
7)	knee joint replacement or high tibial osteotomy on their most painful knee;
8)	plan for joint surgery in next 12 months;
9)	other muscular, joint or neurological condition affecting lower limb function;
10)	needle phobia;
11)	immunosuppression or acute infective processes;
12)	cancer or other tumour-like lesions;
13)	bleeding disorder or receiving anti-coagulation therapy;
14)	presence of a warm tense joint effusion;
15)	platelet count greater than or equal to 150,000/microlitre;
16)	any other medical condition precluding participation in the study including contraindication to MRI such as pregnancy;
17)	be unwilling to discontinue NSAID and other analgesic usage for knee pain, with the exception of paracetamol for rescue pain relief, from 2 weeks prior to baseline assessment until the 12 month follow up assessment;
18)	Body mass index (BMI) >40kg/m2 because of problems fitting in to the MRI machine knee coil; and
19)	Inability to understand written/spoken English.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: University of Melbourne
Primary Sponsor Address: Centre for Health Exercise and Sports Medicine Department of Physiotherapy School of Health Sciences Level 7, Alan Gilbert Building University of Melbourne VIC 3010
Primary Sponsor Country: Australia

Trial website

Trial IDACTRN12617000853347

Contact person for information and recruitmentMr
Ben Metcalf
Centre for Health, Exercise & Sports Medicine Department of Physiotherapy School of Health Sciences University of Melbourne, Vic, 3010

Email contact Further information