ObjectiveTo assess the efficacy of arthroscopic subacromial decompression (ASD) by comparing it with diagnostic arthroscopy, a placebo surgical intervention, and with a non-operative alternative, exercise therapy, in a more pragmatic setting.DesignMulticentre, three group, randomised, double blind, sham controlled trial.SettingOrthopaedic departments at three public hospitals in Finland.Participants210 patients with symptoms consistent with shoulder impingement syndrome, enrolled from 1 February 2005 with two year follow-up completed by 25 June 2015.InterventionsASD, diagnostic arthroscopy (placebo control), and exercise therapy.Main outcome measuresShoulder pain at rest and on arm activity (visual analogue scale (VAS) from 0 to 100, with 0 denoting no pain), at 24 months. The threshold for minimal clinically important difference was set at 15.ResultsIn the primary intention to treat analysis (ASD versus diagnostic arthroscopy), no clinically relevant between group differences were seen in the two primary outcomes at 24 months (mean change for ASD 36.0 at rest and 55.4 on activity; for diagnostic arthroscopy 31.4 at rest and 47.5 on activity). The observed mean difference between groups (ASD minus diagnostic arthroscopy) in pain VAS were −4.6 (95% confidence interval −11.3 to 2.1) points (P=0.18) at rest and −9.0 (−18.1 to 0.2) points (P=0.054) on arm activity. No between group differences were seen between the ASD and diagnostic arthroscopy groups in the secondary outcomes or adverse events. In the secondary comparison (ASD versus exercise therapy), statistically significant differences were found in favour of ASD in the two primary outcomes at 24 months in both VAS at rest (−7.5, −14.0 to −1.0, points; P=0.023) and VAS on arm activity (−12.0, −20.9 to −3.2, points; P=0.008), but the mean differences between groups did not exceed the pre-specified minimal clinically important difference. Of note, this ASD versus exercise therapy comparison is not only confounded by lack of blinding but also likely to be biased in favour of ASD owing to the selective removal of patients with likely poor outcome from the ASD group, without comparable exclusions from the exercise therapy group.ConclusionsIn this controlled trial involving patients with a shoulder impingement syndrome, arthroscopic subacromial decompression provided no benefit over diagnostic arthroscopy at 24 months.Trial registrationClinicaltrials.gov NCT00428870.
ObjectiveTo assess if arthroscopic partial meniscectomy (APM) is superior to placebo surgery in the treatment of patients with degenerative tear of the medial meniscus.MethodsIn this multicentre, randomised, participant-blinded and outcome assessor-blinded, placebo-surgery controlled trial, 146 adults, aged 35–65 years, with knee symptoms consistent with degenerative medial meniscus tear and no knee osteoarthritis were randomised to APM or placebo surgery. The primary outcome was the between-group difference in the change from baseline in the Western Ontario Meniscal Evaluation Tool (WOMET) and Lysholm knee scores and knee pain after exercise at 24 months after surgery. Secondary outcomes included the frequency of unblinding of the treatment-group allocation, participants' satisfaction, impression of change, return to normal activities, the incidence of serious adverse events and the presence of meniscal symptoms in clinical examination. Two subgroup analyses, assessing the outcome on those with mechanical symptoms and those with unstable meniscus tears, were also carried out.ResultsIn the intention-to-treat analysis, there were no significant between-group differences in the mean changes from baseline to 24 months in WOMET score: 27.3 in the APM group as compared with 31.6 in the placebo-surgery group (between-group difference, −4.3; 95% CI, −11.3 to 2.6); Lysholm knee score: 23.1 and 26.3, respectively (−3.2; −8.9 to 2.4) or knee pain after exercise, 3.5 and 3.9, respectively (−0.4; −1.3 to 0.5). There were no statistically significant differences between the two groups in any of the secondary outcomes or within the analysed subgroups.ConclusionsIn this 2-year follow-up of patients without knee osteoarthritis but with symptoms of a degenerative medial meniscus tear, the outcomes after APM were no better than those after placebo surgery. No evidence could be found to support the prevailing ideas that patients with presence of mechanical symptoms or certain meniscus tear characteristics or those who have failed initial conservative treatment are more likely to benefit from APM.
Background Platelet-rich plasma (PRP) and autologous blood are commonly used therapies for lateral epicondylitis, but the evidence from randomized, placebo-controlled trials is conflicting. Thus, it is still unclear if patients benefit from these treatments. Questions/purposes In the setting of a randomized, placebo-controlled trial, we compared PRP, autologous blood, and saline injections in the treatment of lateral epicondylitis with respect to: (1) VAS pain scores, and (2) functional outcomes (DASH score and grip strength) 1 year after treatment. Methods We performed a parallel-group, randomized, controlled participant- and assessor-blinded study including adults with clinically diagnosed lateral epicondylitis. We defined lateral epicondylitis as pain in the lateral humeral epicondyle area exacerbated during resisted wrist extension and epicondyle compression. The participants were recruited from a secondary referral center, after not responding to initial nonoperative treatment. Patients with other concomitant upper-limb symptoms and surgical treatment of the elbow were excluded. Randomization sequence was generated with computer software and concealed from the investigators. We randomized 119 participants to receive an injection of PRP, autologous blood, or saline (1:1:1) in the proximal insertion of the extensor carpi radialis brevis muscle; 40 participants received PRP, 40 received autologous blood, and 39 received a saline injection. To prepare the PRP, we collected venous blood with a syringe kit followed by centrifugation, whereas autologous blood group received unprepared blood injection. Two unblinded investigators gave injections while the participant was unable to see the injection. There was no formal postinjection rehabilitation protocol and the use of NSAIDs was similar between different treatment arms. Follow-up visits were at 4, 8, 12, 26, and 52 weeks after the injection. The primary outcome measure was improvement in pain, measured with VAS scale (without specification as to whether the pain was activity related or at rest; range 0-10; a higher score indicates worse pain; the minimum clinically important difference [MCID] on the 10-cm scale was 1.5 cm), from baseline to 52 weeks. The secondary outcomes were the DASH score (range 0-100; a higher indicates a poorer outcome, and the MCID was 10.2 points) and grip strength. All patients were included in the analyses, and analyses were performed using the intention-to-treat principle. There was no crossover between treatment groups. At 52 weeks, nearly all (95% [38 of 40]) participants in autologous blood group were available for analysis whereas 78% (31 of 40) and 82% (32 of 39) were available in PRP and saline groups. This study was registered at ClinicalTrials.gov and funded by the local hospital district. With 40 patients in each group, we had 80% power to detect a clinically important improvement in pain (1.5 cm on the 10-cm VAS pain scale). Results There were no clinically important differences in the mean VAS pain or DASH scores among the groups at any timepoint. At 52 weeks, the mean difference in the VAS score for pain was -0.2 (95% CI -1.5 to 1.1; p = 0.75) for PRP versus saline and 0.5 (95% CI -0.7 to 1.7; p = 0.40) for autologous blood versus saline. The corresponding mean differences in the DASH score were 0.0 (95% CI -9.2 to 9.2; p > 0.99) and 7.7 (95% CI -1.3 to 16.7; p = 0.09) and those for grip strength were 1.4 kg (95% CI -3.3 to 6.1; p = 0.56) and -0.2 kg (95% CI -5.0 to 4.5; p = 0.92). No complications occurred because of the injections. Conclusions PRP or autologous blood injections did not improve pain or function at 1 year of follow-up in people with lateral epicondylitis compared with those who were given a saline injection. However, because the 95% CIs did not exclude the MCID in VAS scores for autologous blood versus saline at 52 weeks, it is possible that a larger study could identify a between-group difference that we missed, but the effect size of that difference (based on our findings), even if present, is likely still to be small. Until or unless future randomized trials convincingly show a benefit either to PRP or autologous blood injections, we recommend against their use in patients with lateral epicondylitis. Level of Evidence Level II, therapeutic study.
Unipolar hemiarthroplasty group had a significantly higher dislocation rate when compared with bipolar hemiarthroplasty group. However, both provide elderly patients with equal ambulatory ability and low revision rate at medium-term follow-up.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.