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Bone & Joint Open
Vol. 2, Issue 2 | Pages 72 - 78
1 Feb 2021
Agni NR Costa ML Achten J O’Connor H Png ME Peckham N Dutton SJ Wallis S Milca S Reed M

Aims. Patients receiving cemented hemiarthroplasties after hip fracture have a significant risk of deep surgical site infection (SSI). Standard UK practice to minimize the risk of SSI includes the use of antibiotic-loaded bone cement with no consensus regarding type, dose, or antibiotic content of the cement. This is the protocol for a randomized clinical trial to investigate the clinical and cost-effectiveness of high dose dual antibiotic-loaded cement in comparison to low dose single antibiotic-loaded cement in patients 60 years and over receiving a cemented hemiarthroplasty for an intracapsular hip fracture. Methods. The WHiTE 8 Copal Or Palacos Antibiotic Loaded bone cement trial (WHiTE 8 COPAL) is a multicentre, multi-surgeon, parallel, two-arm, randomized clinical trial. The pragmatic study will be embedded in the World Hip Trauma Evaluation (WHiTE) (ISRCTN 63982700). Participants, including those that lack capacity, will be allocated on a 1:1 basis stratified by recruitment centre to either a low dose single antibiotic-loaded bone cement or a high dose dual antibiotic-loaded bone cement. The primary analysis will compare the differences in deep SSI rate as defined by the Centers for Disease Control and Prevention within 90 days of surgery via medical record review and patient self-reported questionnaires. Secondary outcomes include UK Core Outcome Set for hip fractures, complications, rate of antibiotic prescription, resistance patterns of deep SSI, and resource use (more specifically, cost-effectiveness) up to four months post-randomization. A minimum of 4,920 patients will be recruited to obtain 90% power to detect an absolute difference of 1.5% in the rate of deep SSI at 90 days for the expected 3% deep SSI rate in the control group. Conclusion. The results of this trial will provide evidence regarding clinical and cost-effectiveness between low dose single and high dose dual antibiotic-loaded bone cement, which will inform policy and practice guidelines such as the National Institute for Health and Care Excellence guidance on management of hip fractures. Cite this article: Bone Jt Open 2021;2(2):72–78


The Bone & Joint Journal
Vol. 100-B, Issue 8 | Pages 1094 - 1099
1 Aug 2018
Gupta S Malhotra A Mittal N Garg SK Jindal R Kansay R

Aims. The aims of this study were to establish whether composite fixation (rail-plate) decreases fixator time and related problems in the management of patients with infected nonunion of tibia with a segmental defect, without compromising the anatomical and functional outcomes achieved using the classical Ilizarov technique. We also wished to study the acceptability of this technique using patient-based objective criteria. Patients and Methods. Between January 2012 and January 2015, 14 consecutive patients were treated for an infected nonunion of the tibia with a gap and were included in the study. During stage one, a radical debridement of bone and soft tissue was undertaken with the introduction of an antibiotic-loaded cement spacer. At the second stage, the tibia was stabilized using a long lateral locked plate and a six-pin monorail fixator on its anteromedial surface. A corticotomy was performed at the appropriate level. During the third stage, i.e. at the end of the distraction phase, the transported fragment was aligned and fixed to the plate with two to four screws. An iliac crest autograft was added to the docking site and the fixator was removed. Functional outcome was assessed using the Association for the Study and Application of Methods of Ilizarov (ASAMI) criteria. Patient-reported outcomes were assessed using the Musculoskeletal Tumor Society (MSTS) score. Results. The mean age of patients was 38.1 years (. sd. 12.7). There were 13 men and one woman. The mean size of the defect was 6.4 cm (. sd. 1.3). the mean follow-up was 33.2 months (24 to 50). The mean external fixator index was 21.2 days/cm (. sd. 1.5). The complication rate was 0.5 (7/14) per patient. According to the classification of Paley, there were five problems and two obstacles but no true complications. The ASAMI bone score was excellent in all patients. The functional ASAMI scores were excellent in eight and good in six patients. The mean MSTS composite score was 83.9% (. sd. 7.1), with an MSTS emotional acceptance score of 4.9 (. sd. 0.5; maximum possible 5). Conclusion. Composite fixation (rail-plate) decreases fixator time and the associated complications, in the treatment of patients of infected nonunion tibia with a segmental defect. It also provides good anatomical and functional results with high emotional acceptance. Cite this article: Bone Joint J 2018;100-B:1094–9


The Bone & Joint Journal
Vol. 105-B, Issue 10 | Pages 1070 - 1077
1 Oct 2023
Png ME Costa M Nickil A Achten J Peckham N Reed MR

Aims

To compare the cost-effectiveness of high-dose, dual-antibiotic cement versus single-antibiotic cement for the treatment of displaced intracapsular hip fractures in older adults.

Methods

Using data from a multicentre randomized controlled trial (World Hip Trauma Evaluation 8 (WHiTE-8)) in the UK, a within-trial economic evaluation was conducted. Resource usage was measured over 120 days post randomization, and cost-effectiveness was reported in terms of incremental cost per quality-adjusted life year (QALY), gained from the UK NHS and personal social services (PSS) perspective in the base-case analysis. Methodological uncertainty was addressed using sensitivity analysis, while decision uncertainty was handled using confidence ellipses and cost-effectiveness acceptability curves.


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 1 | Pages 108 - 112
1 Jan 2009
Chandrasekar CR Grimer RJ Carter SR Tillman RM Abudu A Buckley L

Endoprosthetic replacement of the proximal femur may be required to treat primary bone tumours or destructive metastases either with impending or established pathological fracture. Modular prostheses are available off the shelf and can be adapted to most reconstructive situations for this purpose. We have assessed the clinical and functional outcome of using the METS (Stanmore Implants Worldwide) modular tumour prosthesis to reconstruct the proximal femur in 100 consecutive patients between 2001 and 2006. We compared the results with the published series for patients managed with modular and custom-made endoprosthetic replacements for the same conditions.

There were 52 males and 48 females with a mean age of 56.3 years (16 to 84) and a mean follow-up of 24.6 months (0 to 60). In 65 patients the procedure was undertaken for metastases, in 25 for a primary bone tumour, and in ten for other malignant conditions. A total of 46 patients presented with a pathological fracture, and 19 presented with failed fixation of a previous pathological fracture. The overall patient survival was 63.6% at one year and 23.1% at five years, and was significantly better for patients with a primary bone tumour than for those with metastatic tumour (82.3% vs 53.3%, respectively at one year (p = 0.003)). There were six early dislocations of which five could be treated by closed reduction. No patient needed revision surgery for dislocation. Revision surgery was required by six (6%) patients, five for pain caused by acetabular wear and one for tumour progression. Amputation was needed in four patients for local recurrence or infection.

The estimated five-year implant survival with revision as the endpoint was 90.7%. The mean Toronto Extremity Salvage score was 61% (51% to 95%). The implant survival and complications resulting from the use of the modular system were comparable to the published series of both custom-made and other modular proximal femoral implants.

We conclude that at intermediate follow-up the modular tumour prosthesis for proximal femur replacement provides versatility, a low incidence of implant-related complications and acceptable function for patients with metastatic tumours, pathological fractures and failed fixation of the proximal femur. It also functions as well as a custom-made endoprosthetic replacement.