The most commonly ruptured tendon is the Achilles tendon, and the incidence is increasing. After Achilles tendon rupture, patients experience limitations in tendon weight-bearing activities, resulting in work disability and many months away from sport. Accelerating recovery and improving the quality of tissue repair are therefore desirable.
Platelet-rich plasma is an autologous whole blood product that provides a supraphysiological concentration of platelets, leukocytes, growth factors, and other bioactive proteins such as cytokines and chemokines for delivery to an injured site.
As platelet-rich plasma has shown positive effects on tendon healing under laboratory conditions in most studies, it is now widely used in orthopedic sports and musculoskeletal medicine, and the market is projected to be worth US$383.56 million (£297.20 million; €344.49 million) by 2023.
Its popularity has been fueled by much media attention after its use by elite athletes.8 However, commercial platelet-rich plasma preparation systems only have approval from the United States Food and Drug Administration based on on device performance and safety, not clinical efficacy .
Despite 37 clinical trials on platelet-rich plasma applications in musculoskeletal injuries so far, its efficacy remains uncertain.
These trials and the two previous ones of platelet-rich plasma in Achilles rupture are hampered by lack of standardization of platelet-rich plasma preparations and quality control, low-powered studies, and potential confounders such as surgery. concurrent.
Achilles tendon rupture offers an optimal clinical model to determine the efficacy of platelet-rich plasma because it has a relatively homogeneous presentation and is easy to diagnose and test mechanically, compared to other tendon rupture sites.
The objective was to determine the clinical efficacy of a standardized platelet-rich plasma preparation in the treatment of acute, non-surgical Achilles tendon rupture in a randomized controlled trial.
We hypothesized that if platelet-rich plasma accelerated tendon healing and improved the mechanical properties of the healing tissue, it would lead to better muscle tendon function in participants.
Summary
Aim
To determine whether an injection of platelet-rich plasma improves outcomes after acute Achilles tendon rupture.
Design
Randomized, placebo-controlled, two arms, parallel group, participant and evaluator masked, superiority trial.
Establishment of secondary care trauma units in 19 hospitals in the UK health service.
Recruitment of participants began in July 2015 and follow-up was completed in March 2018. 230 adults over 18 years of age, with acute Achilles tendon rupture within 12 days of injury and treated with non-invasive treatment were included. surgical.
Exclusions were injury to the musculotendinous insertion or junction, significant leg injury or deformity, diabetes mellitus, hematologic or platelet disorder, systemic corticosteroids, anticoagulant treatment, and other contraindicating conditions .
Interventions
Participants were randomized 1:1 to platelet-rich plasma (n = 114) or placebo (dry needle; n = 116) injection. All participants received standard rehabilitation care (ankle immobilization followed by physical therapy).
Main results and measures
The primary outcome was muscle tendon function at 24 weeks, objectively measured with the limb symmetry index (injured/uninjured × 100) at maximal work performed during the heel rise resistance test (an instrumented measure of repeated heel raises of one leg until fatigue).
Secondary outcomes included patient-reported function (Achilles tendon rupture score), quality of life (short form 12 version 2®), pain (visual analog scale), goal achievement (patient-specific functional scale), and adverse events. A central laboratory analyzed the quality and content of the platelet-rich plasma.
Analyzes were modified intention-to-treat.
Results
Participants were 46 years old on average, and 57 (25%) of 230 were women. At 24 weeks, 202 (88%) participants completed the heel rise resistance test and 216 (94%) patients reported the results.
The platelet-rich plasma was of good quality , with an expected growth factor content.
No difference in muscle tendon function was detected between participants receiving platelet-rich plasma injections and those receiving placebo injections (limb symmetry index, mean 34.7% (standard deviation 17.7%) v 38.5% ( 22.8%); adjusted mean difference −3.9% (95% confidence interval -10.5% to 2.7%)) or in any secondary outcome or adverse event rate. Compliance average causal effect analyzes yielded similar results.
Repeated measures results, mixed effects regression model, showing a change in Achilles tendon rupture score in study participants (receiving platelet-rich plasma v placebo) over time. Bars = 95% confidence intervals
Conclusions There is no evidence to indicate that platelet-rich plasma injections can improve objective muscle tendon function, patient-reported function, or quality of life after acute Achilles tendon rupture compared with placebo, or that offer some benefit to the patient. |
Comments
Platelet-rich plasma provided no benefit after acute Achilles tendon rupture, a trial reported in the BMJ . The autologous whole blood product, which provides a high concentration of platelets, leukocytes, growth factors and cytokines, is widely used in sports and orthopedic medicine.
Participants included 230 adults in 19 UK hospitals with acute Achilles tendon rupture that had occurred in the previous 12 days and was being managed non-surgically.
Patients were randomly assigned to receive a platelet-rich plasma injection or placebo (dry needle injection); All participants also received standard rehabilitation care.
At 24 weeks, there was no difference between the 2 groups in muscle tendon function, patient-reported function, pain, goal achievement, or quality of life.
The authors cautioned that the use of platelet-rich plasma in soft tissue injuries should be questioned.
