PRP Still Struggles For An Indication

New research observed no benefit from the use of platelet-rich plasma (PRP) injection in patients with acute Achilles tendon rupture. “Despite 37 clinical trials on applications of platelet rich plasma in musculoskeletal injuries so far, its efficacy remains uncertain,” the researchers wrote. “These trials, and the two previous trials of platelet rich plasma in Achilles rupture, are hampered by a lack of [standardization] of platelet rich plasma preparations and quality control, underpowered studies, and potential confounders such as concurrent surgery.” The findings of the PATH-2 trial were published in The BMJ. This was a randomized, placebo-controlled, two-arm, parallel group, participant and assessor masked, superiority trial spanning secondary care trauma units in 19 UK-based hospitals. Eligible patients were aged 18 years and older and had a clinical diagnosis of a complete acute mid-substance Achilles tendon rupture sustained within the last 12 days. Patients had to be mobile prior to injury and were being managed nonoperatively with a cast, splint, or boot to immobilize the ankle. Patients were excluded if they were diagnosed with a tendon rupture at the insertion or musculotendinous junction or were pregnant or breastfeeding, or if they had a past major leg injury or deformity, diabetes mellitus, a platelet or hematological disorder, systemic corticosteroids, anticoagulation treatment, lower limb gangrene/ulcers, peripheral vessel disease, hepatic or renal failure/dialysis, inadequate venous access, or a three-month history of radiation or chemotherapy. Patients were recruited between July 28, 2015, and Sept. 18, 2017; follow-up was completed on March 9, 2018. A total of 1,166 patients were initially recruited, of whom 230 were randomized to receive PRP injection (n = 114) or placebo (n = 116). The main outcome measure was 24-week muscle tendon function, which was measured using the limb symmetry index (injured/uninjuredx100) in maximal work done during the heel rise endurance test, which requires patients to repeat single leg heel raises until fatigue. Secondary outcomes included patient-reported function per the Achilles tendon rupture score, quality of life per the 12-item Short Form Survey version 2, visual analog scale score for pain, goal attainment per the patient-specific functional scale, and adverse events. Average patient age in the total cohort was 46 years; 25% of patients (n = 57) were female. After 24 weeks, 202 patients (88%) completed the heel rise endurance test, and 216 (94%) completed the patient-reported outcomes. A total of 201 patients were included in the primary analysis (PRP, n = 100; placebo, n = 101). Muscle tendon function did not differ between the PRP and placebo patients (limb symmetry index, mean [SD] 34.7% [17.7%] vs. 38.5% [22.8%]; adjusted mean difference, –3.9%; 95% confidence interval [CI], –10.5%-2.7%). No significant between-group differences were observed for any of the secondary outcome measures. “We found no evidence that, compared with placebo, platelet rich plasma injections have an effect on objective muscle tendon function, patient reported function, or quality of life after acute Achilles tendon rupture, indicating that platelet rich plasma offers no patient benefit,” concluded the researchers.

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