A pragmatic multicentre, blinded, randomised placebo-controlled trial comparing Platelet Rich Plasma injection (PRP) to placebo (imitation) injection in adults with Achilles tendon rupture. Two sub-studies are embedded within the main study to contribute to the understanding of the PRP mechanism in tendon healing.

niversity of Oxford0 个研究点目标入组 230 人开始时间: 2015年1月12日最近更新: 2023年11月20日

试验速览

2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29150470 protocol 2019 Results article in https://doi.org/10.1136/bmj.l6132 results (added 09/12/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/31869015/ funder report (added 11/12/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33242293/ results of substudy analysis (added 11/12/2020) 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31748208/ (added 14/06/2022)

•All patients with acute Achilles tendon rupture attending outpatient trauma/orthopaedic clinic within 7 days of sustaining the injury will be eligible for inclusion in the trial. Patient is willing and able to give informed consent for participation in the study
•1. Aged 18 years and over
•2. Diagnosed with acute Achilles tendon rupture
•3. Presenting within and receiving study treatment within 12 days post injury
•4. Patients in whom the decision has been made for nonoperative treatment
•5. Able (in the Investigators opinion) and willing to comply with all study requirements
•6. Able to attend a PATH2 study hospital site for the 24 week follow-up
•7. Patient must be Ambulatory prior to injury without the use of walking aids or assistance of another person (added 16/03/2017)

•The patient may not enter the study if ANY of the following apply:
•1. Previous major tendon or ankle injury or deformity to either lower leg
•2. History of diabetes mellitus
•3. Known platelet abnormality or haematological disorder
•4. Current use of systemic cortisone or an anticoagulant
•5. Evidence of lower limb gangrene/ulcers or peripheral vascular disease
•6. History of hepatic or renal impairment or dialysis
•7. Female patients who are pregnant or breast feeding
•8. Is currently receiving or has received radiation or chemotherapy within the last 3 months
•9. Has inadequate venous access for drawing blood
•10. Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the patients ability to participate in the study
•11. Achilles tendon injuries at the insertion to the calcaneum or at the musculotendinous junction (added 16/030/2017)

发起方