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The Bone & Joint Journal
Vol. 105-B, Issue 6 | Pages 668 - 678
1 Jun 2023
Friedman RJ Boettcher ML Grey S Flurin P Wright TW Zuckerman JD Eichinger JK Roche C

Aims

The aim of this study was to longitudinally compare the clinical and radiological outcomes of anatomical total shoulder arthroplasty (aTSA) up to long-term follow-up, when using cemented keel, cemented peg, and hybrid cage peg glenoid components and the same humeral system.

Methods

We retrospectively analyzed a multicentre, international clinical database of a single platform shoulder system to compare the short-, mid-, and long-term clinical outcomes associated with three designs of aTSA glenoid components: 294 cemented keel, 527 cemented peg, and 981 hybrid cage glenoids. Outcomes were evaluated at 4,746 postoperative timepoints for 1,802 primary aTSA, with a mean follow-up of 65 months (24 to 217).


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 31 - 31
1 Mar 2010
Friedman RJ Eriksson BI Borris LC Haas S Huisman MV Kakkar AK Bandel TJ Muehlhofer E Misselwitz F Geerts W
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Purpose: Thromboprophylaxis is recommended for at least 10 days and up to 35 days following total hip replacement (THR). Rivaroxaban is an oral, direct Factor Xa inhibitor in advanced clinical development that showed promise in early clinical trials. The purpose of this randomized, double-blind, double-dummy, phase III study was to compare the efficacy and safety of oral rivaroxaban with subcutaneous enoxaparin for 5 weeks, to prevent venous thromboembolism (VTE) in patients undergoing primary THR.

Method: Patients received 10 mg rivaroxaban orally 6–8 hours after surgery and once daily thereafter, or 40 mg enoxaparin subcutaneously the evening before surgery (restarting 6–8 hours after surgery), and continued once daily. Thromboprophylaxis was administered for 35±4 days, and mandatory, bilateral venography was conducted the next day. The primary efficacy endpoint was the composite of any deep vein thrombosis (DVT), non-fatal pulmonary embolism (PE), and all-cause mortality. The primary efficacy analysis was a test for non-inferiority, followed by a test for superiority. Safety endpoints included major and non-major bleeding during the active treatment period.

Results: A total of 4541 patients were randomized to receive rivaroxaban or enoxaparin. Rivaroxaban significantly reduced the incidence of the composite of DVT, PE, and all-cause mortality compared with enoxaparin (1.1% vs 3.7%, respectively; p< 0.001; relative risk reduction [RRR] 70%). Rivaroxaban also significantly reduced the incidence of major VTE compared with enoxaparin (0.2% vs 2.0%, respectively; p< 0.001; RRR 88%). There were no significant differences in the incidence of major bleeding (0.3% vs 0.1%; p=0.178) or non-major bleeding (5.8% vs 5.8%; p=1.000) between rivaroxaban and enoxaparin, respectively. There was no evidence of cardiac or liver safety issues.

Conclusion: Oral, once-daily rivaroxaban was significantly more effective than subcutaneous, once-daily enoxaparin for extended thromboprophylaxis following THR. Rivaroxaban was not associated with an increased risk of bleeding and had a similar safety profile to enoxaparin. This trial demonstrated the efficacy and safety of a fixed, unmonitored dose of an oral, direct Factor Xa inhibitor – rivaroxaban – for extended thromboprophylaxis after THR.


The Journal of Bone & Joint Surgery British Volume
Vol. 89-B, Issue 6 | Pages 799 - 807
1 Jun 2007
Warwick D Friedman RJ Agnelli G Gil-Garay E Johnson K FitzGerald G Turibio FM

Patients who have undergone total hip or knee replacement (THR and TKR, respectively) are at high risk of venous thromboembolism. We aimed to determine the time courses of both the incidence of venous thromboembolism and effective prophylaxis. Patients with elective primary THR and TKR were enrolled in the multi-national Global Orthopaedic Registry. Data on the incidence of venous thromboembolism and prophylaxis were collected from 6639 THR and 8326 TKR patients.

The cumulative incidence of venous thromboembolism within three months of surgery was 1.7% in the THR and 2.3% in the TKR patients. The mean times to venous thromboembolism were 21.5 days (sd 22.5) for THR, and 9.7 days (sd 14.1) for TKR. It occurred after the median time to discharge in 75% of the THR and 57% of the TKA patients who developed venous thromboembolism. Of those who received recommended forms of prophylaxis, approximately one-quarter (26% of THR and 27% of TKR patients) were not receiving it seven days after surgery, the minimum duration recommended at the time of the study.

The risk of venous thromboembolism extends beyond the usual period of hospitalisation, while the duration of prophylaxis is often shorter than this. Practices should be re-assessed to ensure that patients receive appropriate durations of prophylaxis.


The Journal of Bone & Joint Surgery British Volume
Vol. 79-B, Issue 5 | Pages 816 - 819
1 Sep 1997
An YH Bradley J Powers DL Friedman RJ

We evaluated the effects of a serum protein coating on prosthetic infection in 29 adult male rabbits divided into three groups: control, albumin-coated and uncoated. We used 34 grit-blasted, commercially pure titanium implants. Eleven were coated with cross-linked albumin. All the implants were exposed to a suspension of Staphylococcus epidermidis before implantation.

Our findings showed that albumin-coated implants had a much lower infection rate (27%) than the uncoated implants (62%). This may be a useful method of reducing the infection of prostheses.