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Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_10 | Pages 76 - 76
1 Oct 2022
Russell C Tsang SJ Dudareva M Simpson H Sutherland R McNally M
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Aim. Pelvic osteomyelitis following pressure ulceration results in substantial patient morbidity. Previous studies have reported a heterogenous approach to diagnosis and medical management by physicians, suggesting equipoise on key clinical questions. This study hypothesised that the same equipoise exists amongst Orthopaedic surgeons. Method. An 18-question multiple-choice questionnaire was designed through an iterative feedback process until the final version was agreed by all authors. Likert-type scale responses were used with graded responses (e.g., never/fewer than half of patients/around half of patients/more than half of patients/every patient). The online survey was sent to members of the Musculoskeletal Infection Society (MSIS), the European Bone and Joint Infection Society (EBJIS), and the ESCMID Study Group for Implant-Associated Infections (ESGIAI). No incentive for participation was provided. Results. Amongst respondents, 22/41 were based in Europe and 10/41 from the USA. The majority (29/41) had been in clinical practice between 5—24 years. There was a high priority placed on bone biopsy histology, culture-positive bone sampling, and palpable bone without periosteal covering for diagnosis. Multidisciplinary team approach with plastic surgery involvement at the index procedure was advocated. The strongest indications for surgical intervention were source control for sepsis, presence of an abscess/collection, and prevention of local osteomyelitis progression. Physiological/psychological optimisation and control of acute infection were the primary determinants of surgical timing. There was low utilisation of adjunctive surgical therapies. Local/regional primary tissue transfer or secondary healing with/without VAC were the preferred techniques for wound closure. Recurrent osteomyelitis was the most common reason for prolonged antimicrobial therapy. The majority received bedside advice from an infectious disease-specialist but a quarter of respondents preferred telephone advice. Conclusions. Amongst an international cohort of Orthopaedic Surgeons there was a heterogenous diagnostic and therapeutic approach to pressure-related pelvic osteomyelitis


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_19 | Pages 19 - 19
22 Nov 2024
Hanssen J Veerman K Van der Jagt O Somford M Lammers J Poolman R Peters E Visser J Bos K Verhagen R Vehmeijer S Zijlstra W Nolte P Wouthuyzen-Bakker M Mahdad R Vlasveld I De Boer MG Scheper H
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Aim. Rifampicin and fluoroquinolone based therapy is generally considered as first-choice targeted oral antimicrobial therapy for staphylococcal prosthetic joint infections (PJI) treated with debridement, antibiotics and implant retention (DAIR). Alternative equally effective antimicrobial strategies are urgently needed due to toxicity and drug-drug interactions that frequently occur with this strategy. Data from recent clinical studies suggests equipoise for other antimicrobial treatment regimens. The objective of the Rifampicin Combination Therapy versus Targeted Antimicrobial Monotherapy in the Oral Antimicrobial Treatment Phase of Staphylococcal Prosthetic Joint Infection (RiCOTTA)-trial is to evaluate whether monotherapy with clindamycin is non-inferior to rifampicin/fluoroquinolone combination therapy in patients with staphylococcal PJI that are treated with DAIR. Method. The RiCOTTA-trial is a multicenter, non-inferiority, open-label, randomized controlled trial evaluating clindamycin versus rifampicin/fluoroquinolone combination therapy in the oral treatment phase in patients with staphylococcal PJI managed with DAIR. The trial is performed in 16 hospitals in the Netherlands. Eligible patients are adults with staphylococcal knee or hip PJI managed by DAIR. Patients are included one to six days before antibiotic treatment is switched from intravenous to oral therapy. Patients with a contraindication for rifampicin, with a megaprosthesis or who receive intravenous antibiotics for more than three weeks after initial debridement are excluded. Primary outcome is treatment success one year after finishing antimicrobial treatment. Success is defined as the absence of: i. Infection related re-surgery, ii. New episode of antibiotic treatment for infection of the index joint after the initial treatment phase of 12 weeks, iii. Ongoing use of antibiotics for the index joint at the end of follow-up, iv. Death. The estimated treatment success of rifampicin combination therapy is 85% and the monotherapy strategy is considered not inferior when the difference in treatment success will be less than 10%. Enrolment of 158 patients per group (316 in total) is needed to confirm non-inferiority of monotherapy with a power of 80%. The trial is currently open for enrolment. The study is approved by the Medical Ethics Committee Leiden, the Hague, Delft, the Netherlands and registered under EU trial number 2022-501620-26-00 in Clinical Trial Information System. Conclusions. Currently, the RiCOTTTA study is the largest randomised clinical trial that compares targeted oral monotherapy with rifampicin combination treatment for staphylococcal PJI. Noninferiority of monotherapy would result in a change in national PJI guidelines and enable clinicians to use a more patient-tailored approach when considering antibiotics for patients during the oral treatment phase of PJI


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_7 | Pages 54 - 54
1 Apr 2017
Duncan C
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Cementless stem fixation is a widely used method of stem revision in North America and elsewhere in the world. There is abundant literature in its support. Most of the reports from 1985 to 2005 related to proximally or extensively porocoated designs, the former falling into disfavor with time because of unpredictable outcomes. With few exceptions (e.g. S-ROM) the modularity of these designs was limited to the head/neck junction. But this generation of designs was associated with some issues such as insertional fractures, limited control of anteversion (and risk of dislocation), limited applicability in the setting of severe bone loss (Paprosky Type 4 osteolysis or Vancouver Type B3 periprosthetic fracture), as well as ongoing concern relating to severe proximal stress shielding. In the past decade we have seen the mounting use of a new design concept: tapered fluted titanium stems (TFTS), which incorporate the advantages of titanium (for less flexural rigidity), conical taper (for vertical taper-lock stability), longitudinal ribs or flutes (for rotational stability), and surface preparation which attracts bone ongrowth for long term fixation. Four consecutive reports from our center have documented the superiority of the TFTS in our hands, with encouraging outcomes even when dealing with severe bone loss or periprosthetic fractures. There is an increasing body of other literature which reports a similar experience. Furthermore, with increasing experience and confidence in this design concept, we now use a monoblock or non-modular design in the majority of cases in which a TFTS is indicated. This circumvents the potential drawbacks of stem modularity, including taper corrosion and taper junction fracture. Our recent report of this concept in 104 cases with a 2-year minimum follow-up supports the use of this concept in many if not most stem revisions. The question remains as to which should be favored? Because of equipoise in the outcomes of the two fundamental stem designs, at least in our hands, clearly the surgeon needs to ask other, more practical questions:. Am I familiar enough with the TFTS technique so as to bypass the potential versatility of the modular stem for the simplicity and potential cost savings of the non-modular?. Is this a case in which modularity will offer me distinct advantages (periprosthetic fracture, and severe bone loss as examples). Should I introduce the nonmodular TFTS to my practice, choosing straightforward cases first; ones in which I would comfortably and with confidence use an extensively porocoated stem?


Bone & Joint Open
Vol. 4, Issue 2 | Pages 96 - 103
14 Feb 2023
Knowlson CN Brealey S Keding A Torgerson D Rangan A

Aims

Early large treatment effects can arise in small studies, which lessen as more data accumulate. This study aimed to retrospectively examine whether early treatment effects occurred for two multicentre orthopaedic randomized controlled trials (RCTs) and explore biases related to this.

Methods

Included RCTs were ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation), a two-arm study of surgery versus non-surgical treatment for proximal humerus fractures, and UK FROST (United Kingdom Frozen Shoulder Trial), a three-arm study of two surgical and one non-surgical treatment for frozen shoulder. To determine whether early treatment effects were present, the primary outcome of Oxford Shoulder Score (OSS) was compared on forest plots for: the chief investigator’s (CI) site to the remaining sites, the first five sites opened to the other sites, and patients grouped in quintiles by randomization date. Potential for bias was assessed by comparing mean age and proportion of patients with indicators of poor outcome between included and excluded/non-consenting participants.


Bone & Joint Research
Vol. 3, Issue 5 | Pages 161 - 168
1 May 2014
Mundi R Chaudhry H Mundi S Godin K Bhandari M

High-quality randomised controlled trials (RCTs) evaluating surgical therapies are fundamental to the delivery of evidence-based orthopaedics. Orthopaedic clinical trials have unique challenges; however, when these challenges are overcome, evidence from trials can be definitive in its impact on surgical practice. In this review, we highlight several issues that pose potential challenges to orthopaedic investigators aiming to perform surgical randomised controlled trials. We begin with a discussion on trial design issues, including the ethics of sham surgery, the importance of sample size, the need for patient-important outcomes, and overcoming expertise bias. We then explore features surrounding the execution of surgical randomised trials, including ethics review boards, the importance of organisational frameworks, and obtaining adequate funding.

Cite this article: Bone Joint Res 2014;3:161–8.


The Bone & Joint Journal
Vol. 98-B, Issue 1_Supple_A | Pages 27 - 30
1 Jan 2016
Whitehouse MR Parry MC Konan S Duncan CP

Periprosthetic joint infection (PJI) complicates between 0.5% and 1.2% primary total hip arthroplasties (THAs) and may have devastating consequences. The traditional assessment of patients suffering from PJI has involved the serological study of inflammatory markers and microbiological analysis of samples obtained from the joint space. Treatment has involved debridement and revision arthroplasty performed in either one or two stages.

We present an update on the burden of PJI, strategies for its diagnosis and treatment, the challenge of resistant organisms and the need for definitive evidence to guide the treatment of PJI after THA.

Cite this article: Bone Joint J 2016;98-B(1 Suppl A):27–30.


Bone & Joint 360
Vol. 5, Issue 1 | Pages 26 - 28
1 Feb 2016


Bone & Joint Research
Vol. 3, Issue 5 | Pages 169 - 174
1 May 2014
Rangan A Jefferson L Baker P Cook L

The aim of this study was to review the role of clinical trial networks in orthopaedic surgery. A total of two electronic databases (MEDLINE and EMBASE) were searched from inception to September 2013 with no language restrictions. Articles related to randomised controlled trials (RCTs), research networks and orthopaedic research, were identified and reviewed. The usefulness of trainee-led research collaborations is reported and our knowledge of current clinical trial infrastructure further supplements the review. Searching yielded 818 titles and abstracts, of which 12 were suitable for this review. Results are summarised and presented narratively under the following headings: 1) identifying clinically relevant research questions; 2) education and training; 3) conduct of multicentre RCTs and 4) dissemination and adoption of trial results. This review confirms growing international awareness of the important role research networks play in supporting trials in orthopaedic surgery. Multidisciplinary collaboration and adequate investment in trial infrastructure are crucial for successful delivery of RCTs.

Cite this article: Bone Joint Res 2014;3:169–74.