Assessment of blood injections (Platelet Rich Plasma) on symptomatic early worn out knees.

Randomised controlled trial assessing the effectiveness of platelet rich plasma (PRP) injections on symptomatic early osteoarthritis of the knee

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617001162303

Acronym

PEAK Trial (PRP treatment in Early osteoArthtris Knee)

Enrollment

100

Registered

2017-08-08

Start date

2017-09-01

Completion date

2018-08-01

Last updated

2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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). .

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

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.

Outcome results