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The Bone & Joint Journal
Vol. 101-B, Issue 2 | Pages 207 - 212
1 Feb 2019
Clavé A Gérard R Lacroix J Baynat C Danguy des Déserts M Gatineau F Mottier D

Aims. Cementless primary total hip arthroplasty (THA) is associated with risks of bleeding and thromboembolism. Anticoagulants are effective as venous thromboprophylaxis, but with an increased risk of bleeding. Tranexamic acid (TXA) is an efficient antifibrinolytic agent, but the mode and timing of its administration remain controversial. This study aimed to determine whether two intravenous (IV) TXA regimens (a three-hour two-dose (short-TXA) and 11-hour four-dose (long-TXA)) were more effective than placebo in reducing perioperative real blood loss (RBL, between baseline and day 3 postoperatively) in patients undergoing THA who receive rivaroxaban as thromboprophylaxis. The secondary aim was to assess the non-inferiority of the reduction of blood loss of the short protocol versus the long protocol. Patients and Methods. A multicentre, prospective, randomized, double-blind, placebo-controlled trial was undertaken involving 229 patients undergoing primary cementless THA using a posterior approach, whose extended rivaroxaban thromboprophylaxis started on the day of surgery. There were 98 male and 131 female patients, with a mean age of 65.5 years (32 to 91). The primary outcome, perioperative RBL, was evaluated at 72 hours postoperatively. The efficacy of short- and long-TXA protocols in the reduction of perioperative RBL was compared with a placebo group. Results. TXA significantly reduced perioperative blood loss compared with placebo (p < 0.001); the mean differences were 525.3 ml (short-TXA vs placebo) and 550.1 ml (long-TXA vs placebo). No venous or arterial thromboembolic complications were reported. The upper boundary of the 95% confidence interval, when comparing short and long protocols, was below the pre-specified margin of non-inferiority (p = 0.027). Conclusion. In patients undergoing primary cementless THA, using a posterior approach, who are treated with rivaroxaban for thromboembolic prophylaxis, short- and long-TXA IV protocols are significantly more effective than placebo in reducing perioperative RBL, without any thromboembolic complications. Non-inferiority of a short- versus a long-TXA protocol in reducing perioperative RBL was supported in a secondary analysis


The Bone & Joint Journal
Vol. 101-B, Issue 10 | Pages 1192 - 1198
1 Oct 2019
Sköldenberg OG Rysinska AD Chammout G Salemyr M Mukka SS Bodén H Eisler T

Aims

Radiostereometric analysis (RSA) studies of vitamin E-doped, highly crosslinked polyethylene (VEPE) liners show low head penetration rates in cementless acetabular components. There is, however, currently no data on cemented VEPE acetabular components in total hip arthroplasty (THA). The aim of this study was to evaluate the safety of a new cemented VEPE component, compared with a conventional polyethylene (PE) component regarding migration, head penetration, and clinical results.

Patients and Methods

We enrolled 42 patients (21 male, 21 female) with osteoarthritis and a mean age of 67 years (sd 5), in a double-blinded, noninferiority, randomized controlled trial. The subjects were randomized in a 1:1 ratio to receive a reverse hybrid THA with a cemented component of either argon-gas gamma-sterilized PE component (controls) or VEPE, with identical geometry. The primary endpoint was proximal implant migration of the component at two years postoperatively measured with RSA. Secondary endpoints included total migration of the component, penetration of the femoral head into the component, and patient-reported outcome measurements.


The Bone & Joint Journal
Vol. 105-B, Issue 7 | Pages 729 - 734
1 Jul 2023
Borghi A Gronchi A

Desmoid tumours are a rare fibroblastic proliferation of monoclonal origin, arising in deep soft-tissues. Histologically, they are characterized by locally aggressive behaviour and an inability to metastasize, and clinically by a heterogeneous and unpredictable course. Desmoid tumours can occur in any anatomical site, but commonly arise in the limbs. Despite their benign nature, they can be extremely disabling and sometimes life-threatening, causing severe pain and functional limitations. Their surgical management is complex and challenging, due to uncertainties surrounding the biological and clinical behaviour, rarity, and limited available literature. Resection has been the first-line approach for patients with a desmoid tumour but, during the last few decades, a shift towards a more conservative approach has occurred, with an initial ‘wait and see’ policy. Many medical and regional forms of treatment are also available for the management of this condition, and others have recently emerged with promising results. However, many areas of controversy remain, and further studies and global collaboration are needed to obtain prospective and randomized data, in order to develop an appropriate shared stepwise approach.

Cite this article: Bone Joint J 2023;105-B(7):729–734.


Aims. Arthroscopic microfracture is a conventional form of treatment for patients with osteochondritis of the talus, involving an area of < 1.5 cm. 2. However, some patients have persistent pain and limitation of movement in the early postoperative period. No studies have investigated the combined treatment of microfracture and shortwave treatment in these patients. The aim of this prospective single-centre, randomized, double-blind, placebo-controlled trial was to compare the outcome in patients treated with arthroscopic microfracture combined with radial extracorporeal shockwave therapy (rESWT) and arthroscopic microfracture alone, in patients with ostechondritis of the talus. Methods. Patients were randomly enrolled into two groups. At three weeks postoperatively, the rESWT group was given shockwave treatment, once every other day, for five treatments. In the control group the head of the device which delivered the treatment had no energy output. The two groups were evaluated before surgery and at six weeks and three, six and 12 months postoperatively. The primary outcome measure was the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale. Secondary outcome measures included a visual analogue scale (VAS) score for pain and the area of bone marrow oedema of the talus as identified on sagittal fat suppression sequence MRI scans. Results. A total of 40 patients were enrolled and randomly divided into the two groups, with 20 in each. There was no statistically significant difference in the baseline characteristics of the groups. No complications, such as wound infection or neurovascular injury, were found during follow-up of 12 months. The mean AOFAS scores in the rESWT group were significantly higher than those in the control group at three, six, and 12 months postoperatively (p < 0.05). The mean VAS pain scores in the rESWT group were also significantly lower than those in the control group at these times (p < 0.05). The mean area of bone marrow oedema in the rESWT group was significantly smaller at six and 12 months than in the control group at these times (p < 0.05). Conclusion. Local shockwave therapy was safe and effective in patients with osteochondiritis of the talus who were treated with a combination of arthroscopic surgery and rESWT. Preliminary results showed that, compared with arthroscopic microfracture alone, those treated with arthroscopic microfracture combined with rESWT had better relief of pain at three months postoperatively and improved weightbearing and motor function of the ankle. Cite this article: Bone Joint J 2023;105-B(10):1108–1114


Bone & Joint Open
Vol. 3, Issue 4 | Pages 340 - 347
22 Apr 2022
Winkler T Costa ML Ofir R Parolini O Geissler S Volk H Eder C

Aims. The aim of the HIPGEN consortium is to develop the first cell therapy product for hip fracture patients using PLacental-eXpanded (PLX-PAD) stromal cells. Methods. HIPGEN is a multicentre, multinational, randomized, double-blind, placebo-controlled trial. A total of 240 patients aged 60 to 90 years with low-energy femoral neck fractures (FNF) will be allocated to two arms and receive an intramuscular injection of either 150 × 10. 6. PLX-PAD cells or placebo into the medial gluteal muscle after direct lateral implantation of total or hemi hip arthroplasty. Patients will be followed for two years. The primary endpoint is the Short Physical Performance Battery (SPPB) at week 26. Secondary and exploratory endpoints include morphological parameters (lean body mass), functional parameters (abduction and handgrip strength, symmetry in gait, weightbearing), all-cause mortality rate and patient-reported outcome measures (Lower Limb Measure, EuroQol five-dimension questionnaire). Immunological biomarker and in vitro studies will be performed to analyze the PLX-PAD mechanism of action. A sample size of 240 subjects was calculated providing 88% power for the detection of a 1 SPPB point treatment effect for a two-sided test with an α level of 5%. Conclusion. The HIPGEN study assesses the efficacy, safety, and tolerability of intramuscular PLX-PAD administration for the treatment of muscle injury following arthroplasty for hip fracture. It is the first phase III study to investigate the effect of an allogeneic cell therapy on improved mobilization after hip fracture, an aspect which is in sore need of addressing for the improvement in standard of care treatment for patients with FNF. Cite this article: Bone Jt Open 2022;3(4):340–347


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_III | Pages 371 - 371
1 Mar 2004
Lassen M Bauer K Eriksson B Turpie A
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Aims: To evaluate the inßuence of the type of anesthesia on the superior efþcacy of fondaparinux over enoxaparin in preventing venous thromboembolism (VTE) in orthopedic surgery (RRR > 50%; P< 0.0001). Methods: 4 randomized, double-blind trials were performed: 2 in hip replacement (THR), 1 in North America (NA) and 1 in Europe; 1 in knee surgery (MKS); and 1 in hip-fracture surgery (HF). The choice of anesthesia was left to the investigators. A predeþned covariate analysis according to the type of anesthesia was performed on primary efþcacy. Conclusions: Fondaparinux once-daily started postoperatively provided superior efþcacy versus enoxaparin in preventing VTE whatever the type of anesthesia and may improve convenience in current practice


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_III | Pages 232 - 232
1 Mar 2004
Eriksson B Bauer K Lassen M Turpie A
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Aims: The fondaparinux thromboprophylaxis phase III studies database including 7344 patients in orthopaedic surgery provides information regarding patient management according to country specificities. Methods: 4 randomized double-blind trials were conducted in 376 centers in 23 countries comparing fondaparinux to enoxaparin – 1 in major knee surgery (MKS) in North America (NA); 2 in total hip replacement (THR) in NA and in Europe, respectively; and 1 in hip-fracture (HF) surgery worldwide except in NA. The use of regional anesthesia or cement during surgery, use of stockings during hospitalization, or prolonged prophylaxis (PP) after discharge were left to the investigators. Results: In all studies the majority of patients were women, particularly in HF. The median age was 67 years for THR, 69 years for MKS, and 79 years for HF. In THR studies, regional anesthesia was used more frequently in Europe (59%) than in NA (24.4%). The table summarizes investigators’ practice. Conclusions: There are important differences in the management of orthopedic surgery patients according to country specificities and type of surgery. However, fondaparinux is more effective than enoxaparin for thromboprophylaxis irrespective of patient or surgery characteristics


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_III | Pages 232 - 232
1 Mar 2004
Lassen M Bauer K Eriksson B Turpie A
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Aims: Whether the use of elastic stockings (ES) on top of pharmacological thromboprophylaxis is beneficial remains debated. In a worldwide phase III program including 7344 patients in major orthopaedic surgery, fondaparinux, the first synthetic selective factor Xa inhibitor, demonstrated a substantial benefit over enoxaparin in preventing venous thromboembolism (VTE); risk reduction > 50% without increasing clinically relevant bleeding. The aim of this study was to evaluate the influence of ES on this superior efficacy of fondaparinux. Methods: In all four randomized, double-blind trials, comparing a once daily 2.5 mg s.c. injection of fondaparinux to enoxaparin, the primary efficacy outcome was VTE up to day 11, defined as deep-vein thrombosis (DVT) detected by mandatory bilateral venography, or documented symptomatic DVT or pulmonary embolism. A post-hoc analysis on primary efficacy was performed according to the use of ES. Results: The table shows VTE incidences by day 11 without and with ES. Conclusions: In major orthopaedic surgery, fondaparinux showed a similar superior efficacy over enoxaparin in patients with and without ES, indicating that ES did not influenced the major benefit of this new agent. An additive effect of ES in enoxaparin-treated patients cannot be excluded but the effect is insufficient compared with fondaparinux alone


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_II | Pages 289 - 290
1 May 2010
Lassen M Ageno W Bandel T Borris L Lieberman J Misselwitz F Rosencher N Turpie A
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Introduction: Rivaroxaban is a novel, oral, direct Factor Xa inhibitor in advanced clinical development for the prevention and treatment of thromboembolic disorders. In this phase III trial, the efficacy and safety of thromboprophylaxis with rivaroxaban was compared with enoxaparin in patients undergoing total knee replacement (TKR). Methods: In RECORD3 – a randomized, double-blind trial – patients received rivaroxaban 10 mg 6–8 hours after surgery and once daily (od) thereafter, or enoxaparin 40 mg od beginning the evening before surgery; both were continued for 10–14 days. The primary efficacy outcome was the composite of any deep vein thrombosis (DVT), non-fatal pulmonary embolism (PE) and all-cause mortality. Secondary efficacy outcomes included major venous thromboembolism (VTE; the composite of proximal DVT, PE and VTE -related death) and symptomatic VTE. The primary safety outcome was major bleeding, and other safety outcomes included any on-treatment bleeding and haemorrhagic wound complications (the composite of excessive wound haematoma and surgical-site bleeding). Results: A total of 2531 patients were randomized; 2459 were eligible for inclusion in the safety population and 1702 for the modified intention-to-treat population. The primary efficacy outcome was reported in 9.6% of patients receiving rivaroxaban and 18.9% of patients receiving enoxaparin. This equated to a relative risk reduction of 49% (p< 0.001) with rivaroxaban compared with enoxaparin. The incidence of major VTE was also significantly reduced with rivaroxaban compared with enoxaparin (relative risk reduction 62%, p=0.016). The incidence of symptomatic VTE was significantly lower in the rivaroxaban group than in the enoxaparin group (p=0.005). Major bleeding rates were 0.6% and 0.5% in the rivaroxaban and enoxaparin groups, respectively, and rates of any on-treatment bleeding were 4.9% and 4.8%, respectively. The incidence of haemorrhagic wound complications was 2.1% in the rivaroxaban group and 1.9% in the enoxaparin group. Conclusions: Rivaroxaban was significantly more effective than enoxaparin for the prevention of VTE after TKR, with a similar safety profile. The oral, direct Factor Xa inhibitor rivaroxaban, given as a fixed, unmonitored dose, may have the potential to change clinical practice for thromboprophylaxis after TKR


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 36 - 36
1 Mar 2010
Lassen MR Ageno W Bandel TJ Borris LC Lieberman JR Misselwitz F Rosencher N Turpie AGG
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Purpose: Rivaroxaban is a novel, oral, direct Factor Xa inhibitor in advanced clinical development for the prevention and treatment of thromboembolic disorders. RECORD3 was a phase III trial conducted to compare the efficacy and safety of oral rivaroxaban with subcutaneous enoxaparin for the prevention of venous thromboembolism (VTE) in patients undergoing total knee replacement (TKR). Method: In this randomized, double-blind trial, patients received rivaroxaban 10 mg once daily (od), or enoxaparin 40 mg od. Enoxaparin was initiated the evening before surgery, and rivaroxaban 6–8 hours after surgery; therapy continued for 10–14 days. The primary efficacy outcome was the composite of any deep vein thrombosis (DVT), pulmonary embolism (PE), and all-cause mortality. Secondary efficacy outcomes included major VTE (the composite of proximal DVT, PE, and VTE-related death) and symptomatic VTE. Major bleeding was the primary safety outcome. Other safety outcomes included any on-treatment bleeding and hemorrhagic wound complications (the composite of excessive wound hematoma and surgical-site bleeding). Results: A total of 2531 patients were randomized; 2459 were eligible for inclusion in the safety population and 1702 for the modified intention-to-treat population. The incidence of the primary efficacy outcome was significantly reduced with rivaroxaban compared with enoxaparin (relative risk reduction 49%, p< 0.001). Major VTE occurred in 1.0% and 2.6% of patients receiving rivaroxaban and enoxaparin, respectively (relative risk reduction 62%, p=0.016). The incidence of symptomatic VTE was significantly lower in the rivaroxaban group than in the enoxaparin group (p=0.005). Major bleeding rates were 0.6% and 0.5% in the rivaroxaban and enoxaparin groups, respectively, and rates of any on-treatment bleeding were 4.9% and 4.8%, respectively. The incidence of hemorrhagic wound complications was 2.1% in the rivaroxaban group and 1.9% in the enoxaparin group. Conclusion: Rivaroxaban was significantly more effective than enoxaparin for thromboprophylaxis after TKR. Importantly, the incidence of bleeding was low and similar in both groups. This is the first trial to demonstrate the efficacy and safety of a fixed, unmonitored regimen of an oral, direct Factor Xa inhibitor – rivaroxaban – for thromboprophylaxis after TKR


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_10 | Pages 28 - 28
1 Oct 2020
Schwenk ES Kasper VP Torjman MC Austin MS Brown SA Hozack WJ
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Introduction. Early ambulation after total hip arthroplasty (THA) predicts early discharge. Spinal anesthesia is preferred but can delay ambulation, especially with bupivacaine. Mepivacaine, an intermediate-acting local anesthetic, could enable earlier ambulation than bupivacaine. We hypothesized that patients who received mepivacaine would ambulate earlier than those who received hyperbaric bupivacaine or isobaric bupivacaine for primary THA. Methods. This was a randomized, double-blind controlled trial of patients undergoing primary THA. Patients were randomized 1:1:1 to mepivacaine 52.5 mg, hyperbaric bupivacaine 11.25 mg, or isobaric bupivacaine 12.5 mg for spinal anesthesia. The primary outcome measure was ambulation between 3–3.5 hours. Secondary outcomes included return of motor and sensory function, postoperative pain, opioid consumption, urinary retention, transient neurological symptoms, intraoperative muscle tension, length of stay and 30-day readmissions. A priori power analysis required 44 patients per group. After testing for normality (Shapiro-Wilk test), continuous data were analyzed using analysis of variance (ANOVA) or Kruskal-Wallis, as appropriate, and categorical data were analyzed with chi square. Results. Of 154 patients, 50 received mepivacaine, 53 received hyperbaric bupivacaine, and 51 received isobaric bupivacaine. Patient characteristics were similar among groups. For ambulation at 3–3.5 hours, 35/50 (70.0%) of patients met this endpoint in the mepivacaine group, followed by 20/53 (37.7%) of hyperbaric bupivacaine, and then 9/51 (17.6%) of isobaric bupivacaine (p<0.001). Return of motor function occurred earlier with mepivacaine. Pain and opioid consumption were higher for mepivacaine patients in the early postoperative period only. 23/50 (46.0%) of mepivacaine, 13/53 (24.5%) of hyperbaric bupivacaine, and 11/51 (21.5%) of isobaric bupivacaine patients achieved same-day discharge (p=0.014). Length of stay was shortest in mepivacaine patients. There were no differences in complications. Discussion. Mepivacaine patients ambulated earlier and were more likely to be discharged the same day than both hyperbaric bupivacaine and isobaric bupivacaine patients. Mepivacaine could be beneficial for outpatient THA


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_2 | Pages 4 - 4
1 Feb 2020
Kadado A Bober K Yu C Akioyamen N North T Charters M
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Introduction. Postoperative nausea and vomiting (PONV) is a common occurrence following total joint arthroplasty, and can result in patient discomfort, delayed discharge, and decreased patient satisfaction. Carbohydrate loading as part of the Enhanced Recovery after Surgery (ERAS) protocol has gained popularity, and has been shown to minimize postoperative nausea, vomiting, pain, and lead to accelerated recovery and better overall outcome following abdominal surgery. This study aims to investigate the effects of preoperative carbohydrate-rich drinks on PONV following primary total knee arthroplasty (TKA). Methods. Patients undergoing primary TKA at one institution were enrolled randomly assigned to one of three groups: Group 1 received preoperative carbohydrate-rich drink, Group 2 received placebo water drink of similar appearance and taste, and Group 3 did not receive a drink (control). All healthcare personnel and patients (group 1 and 2) were blinded to group allocation. We compared rate of postoperative nausea, vomiting, length of stay (LOS), and opiate consumption (morphine equivalents, meq). We also reviewed visual analog scale (VAS) pain scores and serum glucose at 0–4 hours, 4–12 hours, and 12–24 hours postoperatively. Results. 229 eligible patients were enrolled and randomized. 79 patients were later excluded due to reasons precluding appropriate participation. 150 patients were included for final analysis, with 50 patients in Group 1, 48 patients in Group 2, and 52 patients in Group 3. The demographics and comorbid conditions known to increase risk of nausea and vomiting were similar between the groups. Rate of vomiting was not statistically significant across groups; group 1 (6%, 3/50), group 2 (13%, 6/48), group 3 (8%, 4/52), p=0.51. Rate of requiring antiemetic medication in group 1 (30%, 15/50) did not differ significantly from group 2 (27%, 13/48) and group 3 (40%, 21/52), p=0.32. Average LOS was not different in group 1 (32 hours) compared to group 2 (32.5 hours) and group 3 (32 hours), p=0.79. Average postoperative opiate consumption for group 1 (57.0 meq) was not statistically different from group 2 (61.3) or group 3 (61.0), p=0.91. Pain VAS scores and serum glucose measurements did not differ between groups for all three time periods (p>0.05). There was no difference in reported adverse events between groups. Conclusion. There appears to be no significant difference in PONV, antiemetic requirements, LOS, pain VAS scores, serum glucose measurements, and opiate consumption in patients receiving preoperative carbohydrate-rich drink prior to primary TKA. Preoperative carbohydrate-rich drinks are safe, however, their utility in the setting of arthroplasty does not yet demonstrate clinical benefit. Continued investigation is required. Summary. This is a prospective, randomized, double-blind, placebo-controlled trial investigating the effect of preoperative carbohydrate-rich drinks on postoperative nausea and vomiting following primary total knee arthroplasty. For any figures or tables, please contact authors directly


Bone & Joint 360
Vol. 13, Issue 2 | Pages 23 - 26
1 Apr 2024

The April 2024 Foot & Ankle Roundup360 looks at: Safety of arthroscopy combined with radial extracorporeal shockwave therapy for osteochondritis of the talus; Bipolar allograft transplantation of the ankle; Identifying risk factors for osteonecrosis after talar fracture; Balancing act: immediate versus delayed weightbearing in ankle fracture recovery; Levelling the field: proximal supination osteotomy’s efficacy in severe and super-severe hallux valgus; Restoring balance: how adjusting the tibiotalar joint line influences movement after ankle surgery.


Bone & Joint 360
Vol. 13, Issue 5 | Pages 47 - 49
1 Oct 2024

The October 2024 Research Roundup360 looks at: Fracture risk among stroke survivors according to post-stroke disability status and stroke type; Noise-induced hearing loss: should surgeons be wearing ear protection during primary total joint replacement?; Intravenous dexamethasone in hip arthroscopy can enhance recovery; Patient-reported outcomes following periprosthetic joint infection of the hip and knee: a longitudinal, prospective observational study; When should surgery take place after weight loss?; Which type of surgery is the hardest physically and mentally?


Bone & Joint 360
Vol. 13, Issue 1 | Pages 26 - 29
1 Feb 2024

The February 2024 Shoulder & Elbow Roundup360 looks at: Does indomethacin prevent heterotopic ossification following elbow fracture fixation?; Arthroscopic capsular shift in atraumatic shoulder joint instability; Ultrasound-guided lavage with corticosteroid injection versus sham; Combined surgical and exercise-based interventions following primary traumatic anterior shoulder dislocation: a systematic review and meta-analysis; Are vascularized fibula autografts a long-lasting reconstruction after intercalary resection of the humerus for primary bone tumours?; Anatomical versus reverse total shoulder arthroplasty with limited forward elevation; Tension band or plate fixation for simple displaced olecranon fractures?; Is long-term follow-up and monitoring in shoulder and elbow arthroplasty needed?


Bone & Joint 360
Vol. 13, Issue 6 | Pages 30 - 33
1 Dec 2024

The December 2024 Shoulder & Elbow Roundup360 looks at: Predicting recurrence of instability after a primary traumatic anterior shoulder dislocation; Predictors of surgery and long-term outcomes in nonoperative management of full-thickness rotator cuff tears; Reverse shoulder arthroplasty viable despite acquired acromial compromise, but higher infection risk noted; LP-PRP reduces retear rates in rotator cuff repair but shows no functional outcome advantage; Long-term clinical outcomes of arthroscopic supraspinatus tendon repair using the single anchor tension band technique – minimum five-year follow-up; Arthroscopic stabilization for anterior shoulder dislocation shows low recurrence rates regardless of prior dislocations; ORIF outperforms arthroplasty for complex radial head fractures: mid-term outcomes; Routine use of surgical helmet systems may not reduce infection risk in shoulder arthroplasty.


The Bone & Joint Journal
Vol. 104-B, Issue 11 | Pages 1242 - 1248
1 Nov 2022
Yang X Arts MP Bartels RHMA Vleggeert-Lankamp CLA

Aims

The aim of this study was to investigate whether the type of cervical disc herniation influences the severity of symptoms at the time of presentation, and the outcome after surgical treatment.

Methods

The type and extent of disc herniation at the time of presentation in 108 patients who underwent anterior discectomy for cervical radiculopathy were analyzed on MRI, using a four-point scale. These were dichotomized into disc bulge and disc herniation groups. Clinical outcomes were evaluated using the Neck Disability Index (NDI), 36-Item Short Form Survey (SF-36), and a visual analogue scale (VAS) for pain in the neck and arm at baseline and two years postoperatively. The perceived recovery was also assessed at this time.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_III | Pages 320 - 320
1 Jul 2011
Zimmerli W Trampuz A
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Implants are highly susceptible to infection [. 1. ]. The infection rate is 0.5–2% after hip or knee arthroplasty [. 2. ]. Periprosthetic joint infections are hard to eradicate. Until recently, two-stage exchange or life-long antibiotic suppression therapy has been the rule. However, novel treatment concepts evolved. Whereas no controlled trials on the surgical management of prosthetic-joint associated infection are available, much is known about the optimal antimicrobial therapy. Modern treatment concepts are based on animal studies, in vitro data, observational studies and one single controlled trial comparing two different antimicrobial regimens in patients with orthopaedic device-associated infections [. 2. ]. The tissue-cage guinea pig model is especially suitable to analyse the role of antibiotics in device-related infections [. 3. ]. In this model, different aspects of implant-associated infections have been studied, namely. host-defense mechanisms around implants [. 1. ],. risk of hematogeneous infection of extravascular devices [. 4. ],. efficacy of prevention or antibiotic treatment [. 5. –. 12. ],. correlation between efficacy of treatment in vivo and in vitro [. 11. ,. 12. ], and the role of biofilm formation on the activity of antibiotics [. 11. ]. Taken together, these experiments showed that an agent acting on slow-growing and adhering microorganism is needed to eradicate device-associated infection. This requirement is only fulfilled by rifamycins in staphylococcal infection and by fluoroquinolones in infections caused by gram-negative bacilli [. 5. –. 12. ]. We could show that even new drugs against methicillin-resistant staphylococci (MRSA), such as linezolid and daptomycin, were not able to eradicate experimental foreign-body infections, when used as single agents. In contrast, in combination with rifampin linezolid cured 60%, and daptomycin 67% of the implant-associated MRSA-infections [. 9. ,. 10. ]. Based on these in vitro and animal data, observational studies were performed in patients with staphylococcal infections associated to orthopedic devices. We developed an algorithm allowing to choose the optimal therapeutic option for each patient [. 2. ]. This algorithm has been validated in cohort studies [. 13. ,. 14. ]. Finally, in a randomized double-blind controlled trial, the benefit of a rifampin-quinolone combination as compared to quinolone monotherapy has been proven in patients with acute orthopedic implant associated staphylococcal infection undergoing debridement with retention [. 15. ]. In conclusion, the favorable role of rifampin has been proven in vitro, in animals and in human studies. Also the newest antistaphylococcal agents must be given in combination with rifampin in order to eliminate infection without removal of the device


Bone & Joint 360
Vol. 11, Issue 4 | Pages 21 - 25
1 Aug 2022


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 104 - 105
1 Mar 2006
Selbmann H Fischer I Moskowitz R
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Background: Clinical studies of Collagen Hydrolysate have suggested efficacy in decreasing symptoms and increasing joint function. Therefore a large multi-center, randomized, double-blind, placebo-controlled trial including 389 patients with osteoarthritis (OA) of the knee was performed with 6 centers in the United States (US), 3 in the United Kingdom (UK) and 11 in Germany (GER). Patients randomly received either identically packaged 10g Pharmaceutical Collagen Hydrolysate (PCH) or 12g lactose (placebo) for 24 weeks. Centers were used as strata for randomization. Acetaminophen (ACET) rescue up to 4g/day was allowed. Primary efficacy parameters were the differences of the WOMAC pain score, the WOMAC physical function score and the Patient Global Evaluation that were measured at the beginning and the end of the study period. No statistically significant differences between treatment groups were observed for the total study population. However, when individual countries were analyzed, a statistically significant treatment advantage of PCH over placebo was observed in all 3 primary efficacy endpoints in Germany (adjusted p-value < 0.05), but neither in the US nor the UK. Purpose: To analyse country differences of the 3 primary endpoints using univariate and multivariate statistical methods. Methods: Since the randomization was done within the centers, the randomization is still valid for a by country analysis. Firstly, the success of the randomization was investigated. Secondly, the influences of certain factors on the effect of the treatment were exploratorily analyzed for each primary efficacy endpoint by a univariate analysis. Thirdly, a multivariate linear regression analysis (for the two continuous primary efficacy endpoints WOMAC pain score and WOMAC physical function score) or a logistic regression (for the discrete primary efficacy endpoint Patient Global Evaluation) was performed. Results: Randomization – No differences of age, gender, and race were determined between the treatment groups in all countries. Univariate analysis – Effects of the placebo, drop-out rate, protocol violations, ACET consumption, and baseline differences in all primary efficacy endpoints show significant differences between Germany and the USA. Multivariate analysis – The drop-out rate was the prognostic factors with the highest effect for all primary efficacy endpoints. Furthermore treatment, country, baseline differences, and ACET intake were also significant prognostic factors. Conclusions:. Although a unique study protocol for all countries was used, the outcomes of PCH compared to placebo were different between the three countries. In multi-national studies strategies for controlling possible cultural influences have to be developed. Results of studies carried out in one country should only be cautiously transferred into another country