Management of adults with primary frozen shoulder in secondary care (UK FROST): a multicentre, pragmatic, three-arm, superiority randomised clinical trial

Manipulation under anaesthesia and arthroscopic capsular release are costly and invasive treatments for frozen shoulder, but their effectiveness remains uncertain. We compared these two surgical interventions with early structured physiotherapy plus steroid injection. In this multicentre, pragmatic, three-arm, superiority randomised trial, patients referred to secondary care for treatment of primary frozen shoulder were recruited from 35 hospital sites in the UK. Participants were adults (≥18 years) with unilateral frozen shoulder, characterised by restriction of passive external rotation (≥50%) in the affected shoulder. Participants were randomly assigned (2:2:1) to receive manipulation under anaesthesia, arthroscopic capsular release, or early structured physiotherapy. In manipulation under anaesthesia, the surgeon manipulated the affected shoulder to stretch and tear the tight capsule while the participant was under general anaesthesia, supplemented by a steroid injection. Arthroscopic capsular release, also done under general anaesthesia, involved surgically dividing the contracted anterior capsule in the rotator interval, followed by manipulation, with optional steroid injection. Both forms of surgery were followed by postprocedural physiotherapy. Early structured physiotherapy involved mobilisation techniques and a graduated home exercise programme supplemented by a steroid injection. Both early structured physiotherapy and postprocedural physiotherapy involved 12 sessions during up to 12 weeks. The primary outcome was the Oxford Shoulder Score (OSS; 0-48) at 12 months after randomisation, analysed by initial randomisation group. We sought a target difference of 5 OSS points between physiotherapy and either form of surgery, or 4 points between manipulation and capsular release. The trial registration is ISRCTN48804508. Between April 1, 2015, and Dec 31, 2017, we screened 914 patients, of whom 503 (55%) were randomly assigned. At 12 months, OSS data were available for 189 (94%) of 201 participants assigned to manipulation (mean estimate 38·3 points, 95% CI 36·9 to 39·7), 191 (94%) of 203 participants assigned to capsular release (40·3 points, 38·9 to 41·7), and 93 (94%) of 99 participants assigned to physiotherapy (37·2 points, 35·3 to 39·2). The mean group differences were 2·01 points (0·10 to 3·91) between the capsular release and manipulation groups, 3·06 points (0·71 to 5·41) between capsular release and physiotherapy, and 1·05 points (-1·28 to 3·39) between manipulation and physiotherapy. Eight serious adverse events were reported with capsular release and two with manipulation. At a willingness-to-pay threshold of £20 000 per quality-adjusted life-year, manipulation under anaesthesia had the highest probability of being cost-effective (0·8632, compared with 0·1366 for physiotherapy and 0·0002 for capsular release). All mean differences on the assessment of shoulder pain and function (OSS) at the primary endpoint of 12 months were less than the target differences. Therefore, none of the three interventions were clinically superior. Arthoscopic capsular release carried higher risks, and manipulation under anaesthesia was the most cost-effective. The National Institute for Health Research Health Technology Assessment programme. [Abstract copyright: Copyright © 2020 The Author(s). Publishedx by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Factors Associated with Revision Surgery after Internal Fixation of Hip Fractures

Background: Femoral neck fractures are associated with high rates of revision surgery after management with internal fixation. Using data from the Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH) trial evaluating methods of internal fixation in patients with femoral neck fractures, we investigated associations between baseline and surgical factors and the need for revision surgery to promote healing, relieve pain, treat infection or improve function over 24 months postsurgery. Additionally, we investigated factors associated with (1) hardware removal and (2) implant exchange from cancellous screws (CS) or sliding hip screw (SHS) to total hip arthroplasty, hemiarthroplasty, or another internal fixation device. Methods: We identified 15 potential factors a priori that may be associated with revision surgery, 7 with hardware removal, and 14 with implant exchange. We used multivariable Cox proportional hazards analyses in our investigation. Results: Factors associated with increased risk of revision surgery included: female sex, [hazard ratio (HR) 1.79, 95% confidence interval (CI) 1.25-2.50; P = 0.001], higher body mass index (fo

Equity issue-specific versus broad regulatory protections against expropriation risk: International evidence from SEOs

We compare non-issue specific (broad) investor protections against expropriation by firm\u27s insiders with regulations that specifically protect investors of new equity issues (issue-specific). Since in-nation regulations rarely change and are homogenous for all firms, it is difficult to compare issue- and non-issue-specific investor protection mechanisms in country-specific studies. We utilize cross-country differences in regulations to study the relative importance of issue-specific and broad regulatory protections. Using data on seasoned equity offerings (SEO), we find that SEO underpricing is related to broad protections. In particular, SEO underpricing is negatively (positively) related with the strength of ex-post (ex-ante) anti-self-dealing laws. Independent of broad protections, SEO underpricing is unaffected by issue-specific investor protections, that is, neither by disclosure requirements imposed on equity issuers nor by equity issue-specific liability rights conferred on investors. Interactions between broad protections and issue-specific protections indicate issue-specific protections reduce SEO underpricing only in countries with strong broad protections

Determinants of underwriting spreads internationally: Evidence from SEOs

We examine the effect of country-level factors on gross underwriting spreads in seasoned equity offerings. Controlling for issue, issuer and underwriter characteristics, we find that primary legal factors that impose direct court costs on underwriters significantly increase spreads. However, secondary legal, economic, and governance factors do not impact spreads significantly. We provide corroborative evidence that preemptive rights lower spreads, and thus, rights offering price concession is a form of transaction cost. We conclude that the non-primary legal factors not captured by market risk are likely incorporated at the time of underwriter-issuer contracting

Welfare effects of expanding banking organization opportunities in the securities arena.

This study examines the welfare consequences of expanding, via deregulation, securities activities of banking organizations. The wealth effect of expanding the permissible scale of Bank Holding Company (BHC) securities activities is redistributive: when revenue limits are relaxed, BHCs gain at the expense of investment banks and their customers. However, removing prudential interaffiliate firewalls to permit BHCs to freely pursue synergies from the joint performance of banking and securities activities shows negative wealth effects for BHCs and an increase in their idiosyncratic risk. Relaxing firewalls appears to raise concerns about stockholder and customer exposure to “ethical risk” loss from management conflicts of interest

Relaxing Glass-Steagall provisions: Wealth and risk effects on foreign banks and their domestic corporate customers.

We provide evidence that expanding the permissible scale of Bank Holding Company (BHC) securities activities in the US redistributes wealth from foreign banks and their domestic customers to domestic BHCs. However, removing prudential interaffiliate firewalls to permit BHCs to freely pursue synergies from the joint performance of banking and securities activities results in wealth losses for all interest groups. Securities activity deregulation increases the systematic risk for the foreign bank sector. Our evidence highlights that the application of the US regulatory policy of national treatment, which seeks to provide equality of competitive opportunity to foreign banking institutions operating in domestic markets, results in competitive inequities

The market valuation effects of the Financial Institutions Reform, Recovery and Enforcement Act of 1989.

This paper evaluates the stock market effects of events leading to the passage of the Financial Institutions Reforms, Recovery, and Enforcement Act of 1989. The evidence suggests that the signing of the Act by President Bush produced positive abnormal returns for both banks and S&Ls and that the addition of tougher capital standards produced positive returns for S&Ls. In addition, the Act increased the risk of both banks and S&Ls

Evidence on foreign direct investment in the United States.

Evidence from foreign direct investment through mergers in the U.S. show overall sample returns to target shareholders that are consistent with prior studies on domestic mergers. However, the returns to stockholders on non-U.K. bidders are significantly positive, which is different from results reported in prior studies. The returns to stockholders of U.K. bidders are significantly negative, which may be attributed to overbidding induced by U.K. tax laws allowing the write-off merger goodwill against reserves rather than against future earning

The market effects of acquisition-related foreign direct investments in the U.S.

Theories of foreign direct investment (FDI) indicate that both location and firm specific advantages must be present for FDI to be feasible. These advantages can be readily exploited by expansion through the utilization of external markets. Therefore, international acquisitions can best be explained by the perceived benefits associated with internalization. Acquisitions allow bidders to capture partially the gains associated with internalization of markets for their products and services, and to partially distribute them to target firm shareholders. The results of this study support the hypothesis that target shareholders receive abnormal positive returns. However, returns to bidder stockholders are zero, indicating that either investors do not price positively the benefits of FDI, or that costs associated with managerial perquisites, the winner’s curse, and ineffective utilization of free cash flow outweigh positive FDI benefits

International acquisitions in the United States: Evidence from returns to foreign bidders.

This paper provides evidence on the minimally explored topic of abnormal returns earned by stockholders of foreign bidders seeking to acquire a target firm in the USA. Four sources of influence on abnormal returns are identified: changes in net wealth of the bidder associated with changes in exchange rates; possible value-destroying managerial discretionary behavior by bidders with excess cash flows, as suggested by Jensen; comparative advantages for foreign bidders domiciled in relatively favorable tax jurisdictions; ownership status of the target, i.e. whether the target is an entire firm and whether it involves divested assets. The study includes 77 firms from 10 countries. The results show that stockholders of foreign bidders earn significant, negative abnormal returns surrounding the announcement of an acquisition in the USA. These abnormal returns become increasingly negative over the 15 days after the announcement of the acquisition, indicating that more information about the acquisition is revealed to investors subsequent to the initial announcement. Cross-sectional regressions indicate that relative exchange rates and cash positions explain variation in abnormal returns. A decline in the value of the dollar increases abnormal returns for the foreign bidder, thus supporting the net wealth hypothesis. The results also show that cash-rich foreign firms tend to enjoy higher abnormal returns when making acquisitions in the USA. The result provides support for the Froot and Stein cash-constrained hypothesis rather than for Jensen\u27s free-cash-flow theory