Data

RESTORE Bennell 2021

The University of Melbourne

Dataset description

Demographic, baseline and 2- and 12-month follow-up data from the RESTORE trial. 288 patients aged 50 years or older with symptomatic radiographic medial knee osteoarthritis. Interventions involved 3 intra-articular injections at weekly intervals of either leukocyte-poor platelet-rich plasma (n = 144) or saline placebo (n = 144). All data presented in the results paper (JAMA. 2021;326(20):2021-2030) available in XLSX format.
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Source Study

Trial acronym

RESTORE

Trial ID

ACTRN12617000853347

Purpose

Treatment

Phase

Not Applicable

Funding

Government body,National Health and Medical Research Council

Scientific enquiries

Prof Kim Bennell

Brief 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 ....
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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.

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 ....
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Can healthy volunteers participate?

No

 

Population

Sample Size    288

Min. age    50 Years

Max. age    No limit

Sex    Both males and females

Condition category    Knee osteoarthritis

Condition code    Musculoskeletal

Intervention

Intervention code Treatment: Other

Platelet-rich plasma (PRP) injections into the knee joint. PRP injections are made from withdrawing and centrifuging the participant’s own blood on the day of treatment. An injection of PRP will be administered to participant’s study knee by a qualified doctor under ultrasound guidance once per week for three weeks. Approximately 20mL of blood from the participant’s arm will be drawn. A research nurse will prepare the injection, and both the participant and injecting doctor will not be told whic ....
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Comparison

Control group Placebo

Placebo injections are the same volume of saline as the PRP injection. An injection of saline solution will be administered into the participant’s knee under ultrasound guidance once per week for three weeks. Approximately 20mL of blood from the participant’s arm will be drawn. A research nurse will prepare the injection, and both the participant and injecting doctor will not be told which treatment group the participant is allocated to. The research nurse will prepare a syringe with a saline so ....
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Outcomes

Outcome: Overall knee pain. Scored on an 11-point numerical rating scale for average overall pain in the last week where 0=no pain and 10=worst pain possible.
Timepoint: Baseline plus 2 months (secondary time point) and 12 months (primary time point) after baseline. *Additionally will be asked at 6 and 9 months to identify pattern of pain trajectory.

Outcome: Medial tibial cartilage volume. A MRI will be performed of the study knee using a 3T whole body system with dedicated extremity coil and a T1-weighted fat suppressed 3D gradient recall acquisition sequence.
Timepoint: Baseline plus 12 months after baseline.

Study Protocol: Not Available
Data Dictionary: Data dictionary

Will individual participant data (IPD) for this trial be available?

yes

What data in particular will be shared?

All data presented in the results paper (JAMA. 2021;326(20):2021-2030) available in XLSX format.

When will data be available?

30-11-2021 to 30-11-2036 (a period of 15 years from publication)

Available to whom?

Data will be made available as required for specific, approved analyses by researchers. Data will be provided from locked, cleaned, and de- identified study database. Requests will be reviewed by the Principal Investigator prior to approval.

Available for what types of analyses?

The investigators endorse the concept of data sharing to advance medical science. All requests for data sharing will be reviewed by the Principal Investigator to ensure no conflict with any planned sub analyses and to ensure that the data are shared in an ethical and protected manner. Analyses aimed to improve treatment of knee osteoarthritis for non-commercial purposes are eligible.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au