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In this multicenter trial involving patients with acute Achilles’ tendon rupture, surgery (open repair or minimally invasive surgery) did not result in better outcomes than nonoperative treatment at 12 months.

AbstractObjectiveTo determine whether an injection of platelet rich plasma improves outcomes after acute Achilles tendon rupture.DesignRandomised, placebo controlled, two arm, parallel group, participant and assessor masked, superiority trial.SettingSecondary care trauma units across 19 hospitals in the United Kingdom’s health service.ParticipantsRecruitment commenced in July 2015 and follow-up was completed in March 2018. 230 adults aged 18 years and over were included, with acute Achilles tendon rupture presenting within 12 days of injury and managed with non-surgical treatment. Exclusions were injury at the insertion or musculotendinous junction, major leg injury or deformity, diabetes mellitus, platelet or haematological disorder, systemic corticosteroids, anticoagulation treatment, and other contraindicating conditions.InterventionsParticipants were randomised 1:1 to platelet rich plasma (n=114) or placebo (dry needle; n=116) injection. All participants received standard rehabilitation care (ankle immobilisation followed by physiotherapy).Main outcomes and measuresPrimary outcome was muscle tendon function at 24 weeks, measured objectively with the limb symmetry index (injured/uninjured×100) in maximal work done during the heel rise endurance test (an instrumented measure of repeated single leg heel rises until fatigue). Secondary outcomes included patient reported function (Achilles tendon rupture score), quality of life (short form 12 version 2®), pain (visual analogue scale), goal attainment (patient specific functional scale), and adverse events. A central laboratory analysed the quality and content of platelet rich plasma. Analyses were by modified intention to treat.ResultsParticipants were 46 years old on average, and 57 (25%) of 230 were female. At 24 weeks, 202 (88%) participants completed the heel rise endurance test and 216 (94%) the patient reported outcomes. The platelet rich plasma was of good quality, with expected growth factor content. No difference was detected in muscle tendon function 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 outcomes or adverse event rates. Complier average causal effect analyses gave similar findings.ConclusionsThere is no evidence to indicate that injections of platelet rich plasma can improve objective muscle tendon function, patient reported function, or quality of life after acute Achilles tendon rupture compared with placebo, or that they offer any patient benefit.Trial registrationISRCTN54992179.

Acute Achilles tendon rupture is one of the most common tendon injuries in adults. We hypothesized that Platelet-Rich Plasma (PRP) can be used as biological augmentation for surgical treatment of acute Achilles tendon rupture. Our study is a prospective randomized controlled trial. Patients with acute Achilles tendon rupture undergoing surgical repair were randomly assigned into either control group or PRP group. End-to-end modified Krackow suture was performed in both groups. In the PRP group, PRP was injected into the paratenon sheath and around the ruptured tissue after the tendon was repaired. Postoperatively we evaluated isokinetic muscle strength at 3, 6, 12, and 24 months. In addition, ankle ROM, calf circumference, Leppilahti score, and the SF-36 score were evaluated at 6, 12, and 24 months after operation. At 3 months, the PRP group had better isokinetic muscle. The PRP group also achieved higher SF-36 and Leppilahti scores at 6 and 12 months. At 24 months, the PRP group had an improved ankle range of motion compared to the control group. Our study results suggest that PRP can serve as a biological augmentation to acute Achilles tendon rupture repair and improves both short and midterm functional outcomes.

Tendons have limited reparative ability and perform a relatively simple mechanical function via the extracellular matrix. Thus, the injured tendon might be treated successfully by stem cell transplantation. We performed a randomized, controlled study to investigate the effects of mesenchymal stem cell injection for treating partial tears in the supraspinatus tendon. We enrolled 24 patients with shoulder pain lasting more than 3 months and partial tears in the supraspinatus tendon. Participants were assigned to three groups: stem cells in fibrin glue, normal saline/fibrin glue mixture, and normal saline only, with which intra-lesional injection was performed. Pain at activity and rest, shoulder function and tear size were evaluated. For safety measures, laboratory tests were taken and adverse events were recorded at every visit. Participants were followed up at 6, 12 weeks, 6, 12 months and 2 years after injection. The primary outcome measure was the improvement in pain at activity at 3 months after injection. Twenty-three patients were included in the final analysis. Primary outcome did not differ among groups ( p  = 0.35). A mixed effect model revealed no statistically significant interactions. Only time significantly predicted the outcome measure. All participants reported transient pain at the injection site. There were no differences in post-injection pain duration or severity. Safety measures did not differ between groups, and there were no persistent adverse events. Stem cell injection into supraspinatus partial tears in patients with shoulder pain lasting more than 3 months was not more effective than control injections. ClinicalTrials.gov Identifier: NCT02298023

Purpose An Achilles tendon rupture is a common injury that typically affects people in the middle of their working lives. The injury has a negative impact in terms of both morbidity for the individual and the risk of substantial sick leave. The aim of this study was to investigate the cost-effectiveness of surgical compared with non-surgical management in patients with an acute Achilles tendon rupture. Methods One hundred patients (86 men, 14 women; mean age, 40 years) with an acute Achilles tendon rupture were randomised (1:1) to either surgical treatment or non-surgical treatment, both with an accelerated rehabilitation protocol (surgical n  = 49, non-surgical n  = 51). One of the surgical patients was excluded due to a partial re-rupture and five surgical patients were lost to the 1-year economic follow-up. One patient was excluded due to incorrect inclusion and one was lost to the 1-year follow-up in the non-surgical group. The cost was divided into direct and indirect costs. The direct cost is the actual cost of health care, whereas the indirect cost is the production loss related to the impact of the patient’s injury in terms of lost ability to work. The health benefits were assessed using quality-adjusted life years (QALYs). Sampling uncertainty was assessed by means of non-parametric boot-strapping. Results Pre-injury, the groups were comparable in terms of demographic data and health-related quality of life (HRQoL). The mean cost of surgical management was €7332 compared with €6008 for non-surgical management ( p  = 0.024). The mean number of QALYs during the 1-year time period was 0.89 and 0.86 in the surgical and non-surgical groups respectively. The (incremental) cost-effectiveness ratio was €45,855. Based on bootstrapping, the cost-effectiveness acceptability curve shows that the surgical treatment is 57% likely to be cost-effective at a threshold value of €50,000 per QALY. Conclusions Surgical treatment was more expensive compared with non-surgical management. The cost-effectiveness results give a weak support (57% likelihood) for the surgical treatment to be cost-effective at a willingness to pay per QALY threshold of €50,000. This is support for surgical treatment; however, additionally cost-effectiveness studies alongside RCTs are important to clarify which treatment option is preferred from a cost-effectiveness perspective. Level of evidence I.

Introduction. Tendon adhesion to surrounding tissues is the most common complication reported after tendon repair. To date, effective solutions to prevent tendon injury are still lacking. Materials and Methods. A total of 89 patients with flexor tendon injury in zone II were recruited. The patients were divided into a control group, a poly-DL-lactic acid (PDLLA) group, and an amnion group according to the different tendon treatments applied. The control group was not subjected to other treatments. PDLLA and bioamniotic membranes were, respectively, used to wrap broken ends in the PDLLA and amnion membrane groups. The patients were followed at 1, 2, 3, 6, and 12 months after surgery and the ranges of active flexion and extension lag in the proximal and distal interphalangeal joints were evaluated. Results. The means of total active ranges of motion of the interphalangeal joints (excluding rupture cases) in the PDLLA and amnion groups did not significantly differ between each other but significantly differed from that of the control group. Statistical analysis showed a significant difference in the clinical grades of the outcomes among the control, PDLLA, and amnion groups. The incidence of complications in the control and PDLLA groups was found to be significantly higher than that in the amniotic membrane group; no significant difference was observed between the control and PDLLA groups. Conclusion. In this study, freeze-dried amniotic membrane transplantation was applied to promote healing of the flexor tendon in zone II and prevent adhesion. This technique presents a new method to solve the issue of tendon adhesion after repair. Clinical Trial Registration. The trial was registered by identifier ChiCTR1900021769.

Purpose The aim of this study was to evaluate, in a meta-analysis, the clinical effectiveness of operative treatment for acute Achilles tendon rupture (AATR) compared with nonoperative treatment. Methods We systematically searched six electronic databases (Medline, Embase, Clinical Ovid, BIOSIS and Cochrane registry of controlled clinical trials) to identify randomised controlled trials (RCTs) in which operative treatment was compared with nonoperative treatment for AATR from 1980 to 2011. Trial quality was assessed using the modified Jadad scale. The data was using fixed-effects and random-effects models with mean differences and risk ratios for continuous and dichotomous variables, respectively. Results Ten RCTs with a total of 894 patients were screened. The results showed that operative was superior to nonoperative treatment regarding lower risk of re-rupture ( P  = 0.002) and shorter time for sick leave ( P  = 0.009) but inferior to nonoperative treatment regarding complication risks ( P  = 0.004). No significant difference was identified between the two methods regarding the number of patients who successfully returned to pre-injury sports ( P  = 0.30). Subgroup analyses revealed significant differences in relation to scar adhesion ( P  < 0.00001), superficial infection ( P  = 0.05), and sensibility disturbance ( P  = 0.0003). However, no significant differences were found between the two interventions in relation to deep infection ( P  = 0.22), deep vein thrombosis (DVT) ( P  = 0.14), and extreme Achilles tendon lengthening ( P  = 0.31). Little consensus was obtained in the functional recovery from current trials as a result of an inconsistent assessment system. Conclusions Compared with conservative treatment, operative treatment can effectively reduce the risk of re-rupture but increase the probability of complications. The increased complication risk may be associated with open repair surgery. However, no sufficient evidence is available from current studies to support the belief that operation may lead to better functional recovery.

Purpose. To evaluate the clinical and ultrasonographic changes in the morphology and vascularity of the common extensor tendon after injecting platelet-rich plasma (PRP) or corticosteroid (CS) for recalcitrant lateral epicondylitis (LE). Methods. 30 patients aged 18 to 60 years with recalcitrant (>6 months) LE not responsive to oral medication or non-invasive treatment were randomised to receive PRP (n=15) or CS (n=15) injection. Patients were assessed using the visual analogue scale (VAS) for pain, Disabilities of the Arm, Shoulder and Hand Scale (DASH) score, Oxford Elbow Score, modified Mayo Clinic performance index for the elbow (modified Mayo score), and hand grip strength. Ultrasonography was performed by a musculoskeletal ultrasonologist to evaluate for tear at the common extensor origin, oedema at the common extensor origin, cortical erosion, probe-induced tenderness, and thickness of the tendon. Results. The VAS for pain, DASH score, Oxford Elbow Score, modified Mayo score, and hand grip strength all improved significantly from pre-injection to the 6-month follow-up in the PRP and CS groups. However, in the CS group, the scores generally peaked at 3 months and then deteriorated slightly at 6 months indicating recurrence of symptoms, which involved 46.7% of the CS patients. At 6 months, the number of patients positive for various ulrasonographic findings generally decreased. However, in the CS group, the number of patients with reduced thickness of the common extensor tendon increased from 2 to 12, and the number of patients with cortical erosion at the lateral epicondyle increased from 9 to 11. Conclusion. PRP appeared to enable biological healing of the lesion, whereas CS appeared to provide short-term, symptomatic relief but resulted in tendon degeneration.

Purpose Acute Achilles tendon rupture leads to impaired outcome at short term, but little is known concerning medium-term results. The aim of the present study was to investigate the influence of early weight-bearing on clinical outcome 4.5 years after nonoperative treatment of acute Achilles tendon rupture. Method The study was performed as a medium-term follow-up on patients included in a randomised controlled trial. Both groups were treated with nonoperative management and controlled early motion. The intervention group was allowed full weight-bearing from day 1, and the control group was non-weight-bearing for 6 weeks. 60 patients were randomised 1:1. Of those, 56 were eligible for inclusion in the medium-term follow-up and 37 participated (18 control, 19 intervention). The outcomes were Achilles tendon Total Rupture Score (ATRS) and heel raise work performed at an average of 4.5 years after the initial injury. Statistical analysis was performed using paired t tests and linear regression. Results No differences were found between control and intervention groups at 4.5 years. ATRS scores consistently improved in both the intervention and the control groups from 0.5 to 1 year and from 1 to 4.5 years, ending up at 80.5 on average after 4.5 years. Heel raise height kept improving from 0.5 to 4.5 years, reaching a limb symmetry index of 82.4%. The heel raise work improvement from 0.5 to 1 year did not continue. No significant change was found from 1 to 4.5 years, ending at a limb symmetry index of 60%. Conclusion Early weight-bearing did not influence outcome 4.5 years after nonoperative treatment of acute Achilles tendon rupture. The calf muscle of the injured limb performs 40% less work, when compared to the healthy limb, though lifting height recovers better. Level of evidence II. Clinical trials identifier NCT02760784.

The aim of this study was to evaluate the effect of adipose-derived stem cells (ADSCs) in the treatment of acute rupture of the Achilles tendon. It was a cross-sectional study involving 15 patients. Patients were randomly divided: group 1—rupture; group 2—suture; group 3—rupture + ADSCs. In the AOFAS score, the score was higher in group 3 with a significant difference. In the ATRS score, the score was higher in groups 2 and 3, also with a significant difference. As for the ultrasound score, there was a significant difference between the experimental groups in relation to this score, however, in the multiple comparisons test, comparing two groups at a time, it was possible to observe a significant difference of the experimental groups. It can be concluded that cell therapy in this condition may be a treatment option due to tissue regeneration and significant recovery of function.