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Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_18 | Pages 114 - 114
14 Nov 2024
Yalcinkaya A Tirta M Rathleff MS Iobst C Rahbek O Kold S
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Introduction. The heterogeneity of outcomes used in the field of lower limb lengthening surgery (LLLS) affects our ability to synthesize evidence. This hampers robust systematic reviews and treatment recommendations for clinical practice. Ultimately this reduces the impact of research for both patients and healthcare professionals. This scoping review aimed to describe the outcomes and outcome measurement instruments (OMIs) used within the field of LLLS. Method. A systematic literature search of WOS, Scopus, Embase, MEDLINE, and the Cochrane Library identified all studies reporting outcomes in children and adults after LLLS. All outcomes and OMIs were extracted verbatim. An iterative process was used to group outcome terms under standardized outcome headings categorized using the COMET Taxonomy of Outcomes. Result. Data saturation was achieved in 2020. A total of 142 studies were included between 2024-2020, reporting 2964 verbatim outcomes with 663 standardized outcome terms collapsed into 119 outcome headings (subdomains). A total of 29 patient-reported and 26 clinician-reported outcome instruments were identified. The most commonly reported outcome was “Lengthening amount”, reported in over 72% of the included studies, while “health-related quality of life” was measured in 16% and all life impact outcomes were reported in 19% of the included studies. Conclusion. A large number of peer-reviewed publications are available, demonstrating that significant resources are being devoted to research on LLLS. However, reported outcomes for people with LLLS are heterogeneous, subject to reporting bias, and vary widely in the definitions and measurement tools used to collect them. Outcomes likely to be important to patients, such as quality of life and measures of physical function, have been neglected. This scoping review identifies a need to standardize outcomes and outcome measures reported on patients recovering from lower limb lengthening surgery; this can be addressed by creating a core set of outcomes


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_8 | Pages 31 - 31
11 Apr 2023
Powell D Wu B Dietz P Bou-Akl T Ren W Markel D
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Failure of osseointegration and periprosthetic joint infection (PJI) are the two main reasons of implant failure after total joint replacement (TJR). Nanofiber (NF) implant surface coating represents an alternative local drug eluting device that improves osseointegration and decreases the risk of PJI. The purpose of this study was to investigate the therapeutic efficacies of erythromycin (EM)-loaded coaxial PLGA/PCL-PVA NF coating in a rat S. aureus-infected tibia model. NF coatings with 100mg and 1000mg EM were prepared. NF without EM was included as positive control. 56 Sprague Dawley rats were divided into 4 groups. A titanium pin (1.0-mm x 8 mm) was placed into the tibia through the intercondylar notch. S. aureus (SA) was introduced by both direct injection of 10 μl broth (1 × 10. 4. CFU) into the medullary cavity and single dip of Ti pins into a similar solution prior to insertion. Rats were sacrificed at 8 and 16 weeks after surgery. The outcome measurements include μCT based quantitative osteolysis evaluation and hard tissue histology. Results: EM-NF coating (EM100 and EM1000) reduced osteolysis at 8 and 16 weeks, compared to EM0 and negative control. The effective infection control by EM-NFs was further confirmed by hard tissue section analysis. The Bone implant contact (BIC) and bone area fraction Occupancy (BAFO) within 200 µm of the surface of the pins were used to evaluate the osseointegration and new bone formation around the implants. At 16 weeks, the bone implant contact (BIC) of EM 100 (35.08%) was higher than that of negative control (3.43%) and EM0 (0%). The bone area fraction occupancy within 200 µm (BAFO) of EM100 (0.63 mm2) was higher than that of negative control (0.390 mm2) and EM0 (0.0 mm. 2. ). The BAFO of EM100 was also higher than that of EM1000 (0.3mm. 2. ). There was much less osteolysis observed with EM100 and EM1000 NF coatings at 16 weeks, as compared to EM0 positive control, p=0.08 and p=0.1, respectively. Osseointegration and periprosthetic bone formation was enhanced by EM-NFs, especially EM100. Data from this pilot study is promising for improving implant surface fabrication strategies


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_16 | Pages 26 - 26
1 Dec 2021
Edwards T Daly C Donovan R Whitehouse M
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Abstract. Objectives. There is debate regarding the optimal surgical technique for fixing femoral diaphyseal fractures in children aged 4 to 12 years. The aim of this study was to conduct a systematic review and meta-analysis to compare the complication rate following flexible intramedullary nailing (FIN), plate fixation and external fixation (EF) for traumatic femoral diaphyseal fractures in children aged 4 to 12. Methods. We searched MEDLINE, EMBASE and CENTRAL databases for interventional and observational studies. Two independent reviewers screened, assessed quality and extracted data from the identified studies. The primary outcome was the risk of any complication. Results. Nine randomised controlled trials (RCTs) and 19 observational studies fulfilled the eligibility criteria. Within the RCTs, five analysed FIN (n=161), two analysed plates (n=51) and five analysed EF (n=168). Within the observational studies, 13 analysed FIN (n=610), seven analysed plates (n=214) and six analysed EF (n=153). The overall risk of complications was lower following plate fixation when compared to FIN (RR 0.45, 95% CI 0.28 to 0.73, p=0.001) in the observational studies. The overall risk of complications was higher following EF when compared to FIN in both RCTs (RR 1.94, 95% CI 1.25 to 3.01, p=0.003) and observational studies (RR 1.97, 95% CI 1.50 to 2.58, p<0.001). The overall risk of complications was higher following EF when compared to plate fixation in both RCTs (RR 7.42, 95% CI 1.84 to 29.98, p=0.005) and observational studies (RR 4.39, 95% CI 2.64 to 7.30, p<0.001). Conclusions. This study reports a significantly decreased relative risk of complications when femoral diaphyseal fractures in children aged 4 to 12 are managed with plates. The overall quality of evidence is low, highlighting the need for a prospective multicentre randomised trial at low risk of bias due to randomisation and outcome measurement to identify if any fixation technique is superior


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_13 | Pages 155 - 155
1 Nov 2021
Edwards T Daly C Donovan R Whitehouse M
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Introduction and Objective. The most common paediatric orthopaedic injury requiring hospital admission is a femoral fracture. There is debate regarding the optimal surgical technique for fixing femoral diaphyseal fractures in children aged 4 to 12 years. The National Institute for Health and Care Excellence (NICE) and the American Academy of Orthopaedic Surgeons (AAOS) have issued relevant guidelines, however, there is limited evidence to support these. The aim of this study was to conduct a systematic review and meta-analysis to compare the complication rate following flexible intramedullary nailing (FIN), plate fixation and external fixation (EF) for traumatic femoral diaphyseal fractures in children aged 4 to 12. Materials and Methods. We searched MEDLINE, EMBASE and CENTRAL databases for interventional and observational studies. Two independent reviewers screened, assessed quality and extracted data from the identified studies. The primary outcome was the risk of any complication. Secondary outcomes assessed the risk of pre-specified individual complications. Results. Nine randomised controlled trials (RCTs) and 19 observational studies (six prospective and 13 retrospective) fulfilled the eligibility criteria. Within the RCTs, five analysed FIN (n=161), two analysed plates (n=51) and five analysed EF (n=168). Within the observational studies, 13 analysed FIN (n=610), seven analysed plates (n=214) and six analysed EF (n=153). The overall risk of complications was lower following plate fixation when compared to FIN fixation (RR 0.45, 95% CI 0.28 to 0.73, p=0.001) in the observational studies. The overall risk of complications was higher following EF when compared to FIN fixation in both RCTs (RR 1.94, 95% CI 1.25 to 3.01, p=0.003) and observational studies (RR 1.97, 95% CI 1.50 to 2.58, p<0.001). The overall risk of complications was higher following EF when compared to plate fixation in both RCTs (RR 7.42, 95% CI 1.84 to 29.98, p=0.005) and observational studies (RR 4.39, 95% CI 2.64 to 7.30, p<0.001). Conclusions. Although NICE and the AAOS recommend FIN for femoral diaphyseal fractures in children aged 4 to 12, this study reports a significantly decreased relative risk of complications when these injuries are managed with plates. Our findings provide valuable information to healthcare professionals who are involved in discussing the risk and benefits of different management options with patients and their families. The overall quality of evidence is low, highlighting the need for a rigorous prospective multicentre randomised trial at low risk of bias due to randomisation and outcome measurement to identify if any fixation technique is superior


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_9 | Pages 37 - 37
1 May 2017
Roberts J Din NU Hawkes C Morrison V Lemmey A Williams N
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Background. Proximal femoral fracture is a common, major health problem resulting in loss of functional independence and a high cost burden on society. Rehabilitation can potentially maximise functional recovery, but evidence of effectiveness is lacking. An enhanced rehabilitation intervention designed to improve self-efficacy and increase the amount and quality of practice of physical exercise and activities of daily living has been developed consisting of patient held workbooks and extra therapy sessions in the community. This study aims to define characteristics of the cohort of individuals this intervention is targeted to, assess acceptability of the intervention and feasibility of recruiting participants for a larger scale trial. Methods. An anonymous cohort study of all proximal femoral fracture patients admitted to three acute hospitals will provide details on residence pre-admission, type of fracture, type of surgery, adverse events and subsequent readmissions. A separate randomised feasibility study recruiting participants from this cohort will assess acceptability and feasibility of the study in terms of eligibility, recruitment, reasons for decline, retention and outcome measure completion. The success rate of identifying patients for the feasibility study and whether the recruited participants are representative of the cohort population will be evaluated by comparison of the feasibility participant screening and background data with that of the cohort. Results. 541 patients were screened for the feasibility study between June 2014 and February 2015 (ongoing). 298 were ineligible, 243 were eligible and 53 (22%) have been recruited to date. Lack of capacity is the leading cause of ineligibility and burden of taking part is perceived as a significant block to participation. Completion rate of outcome measures is high at baseline and follow up. Conclusions. Recruitment from the acute setting is challenging. However, study processes, outcome measurement and intervention is well tolerated by participants. Level of Evidence. I - Well conducted Randomised Trial (Pilot)


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_1 | Pages 64 - 64
1 Jan 2017
Somodi S Andersen K Ebskov L Rasmusen P Muharemovic O Penny J
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The CCI mobile bearing ankle implant used at our orthopedic department 2010–2013, was abandoned due to failures and findings of bone loss at revision. The aim of this study was to a) Determine our true revision rate, b) Investigate accuracy of measuring prevalence, size and location of periprosthetic bone cysts through X-ray and CT and c) Relate these findings to implant alignment and patient reported outcome measurements (PROMs). 51 primary surgeries were performed, prior to this study 8 had been revised. Out of 43 un-revised patients, 36 were enrolled and underwent evaluation with metal artefact reduction CT-scans and conventional X-ray. They filled out 3 PROMs; SEFAS, SF-12, EQ-5D. Cyst volume larger than 0.1 ml was measured using VITREA volume tools for CT-scans and calculation of spherical volume for X-rays; using AP- and lateral projections. Location of lesions was recorded, according to their position relative to the implant. Medial-/lateral- and anterior-/posterior tilt of the implant parts was measured using IMPAX built in measuring tools, applied to AP- and lateral X-ray projection. The relation between lesions location and alignment of components was analyzed by logistic regression. Bias and ICC estimation between CT and X-ray was analyzed by mixed effect model. Log transformation was used to fit the normal distribution assumption. PROMs association to osteolytic volume was analyzed by linear- and logistic regression. P-values of 0.05 were considered statistically significant. Finding large osteolytic lesions caused 4 additional patients to undergo revision and 7 are being monitored due to high risk of failure. Of the original 51 implants 14 have been revised. 8 cases because of osteolytic lesions and aseptic loosening (true revisions w. exchange of components or bone transplants), 3 periprosthetic fractures (2 non-traumatic fractures) and 3 cases of exostosis. The 3- and 5 year revision rate was 14% and 16% for true revisions and 17% and 27% overall. Cystic lesions were found in 81% of participants. Total cyst-volume was on average 13% larger on X-ray, however this difference was not significant (p = 0.55), with intraclass correlation being 0.66. Total cystic volume was not significantly related to PROM-scores (P 0.16–0.5). Location of cysts showed association with alignment of components (P 0.02–0.08). Mean tibia component anterior tilt was 89 degrees (SD 4). Mean medial tilt was 91 degrees (SD 3) for the tibial and 90 degrees (SD 4) for the talar component. The implant investigated performs below standard, compared to public registries. 1, 2. that report overall 5 year revision rates at 5 – 6.5%. We obtained larger measurements from X-rays than CT, unlike previous studies comparing these modalities. Cysts were common and large. Correlation between lesion location and alignment of implant, with valgus and anterior tilt of components causing more lesions in adjacent zones, may suggest a link between implant failure and alignment of components


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXVIII | Pages 31 - 31
1 Jun 2012
Hussain S Cairns D Mann C Horey L Patil S Meek R
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The objective was to compare vastus lateralis muscle splitting verses muscle sparing surgical approach to proximal femur for fixation of intertrochanteric fracture. Of the 16 patients in this prospective randomised double blind study 8 were randomised to vastus lateralis muscle splitting and rest to muscle sparing group. Main outcome measurement was assessment of status of vastus lateralis muscle at 2 and 6 weeks using nerve conduction study. Preoperative demographics were identical for both the groups. There was no statistically significant difference between the groups with regards to velocity, latency, and amplitude. The postoperative haemoglobin drop, heamatocrit, position of the dynamic hip screw and mobility status were identical. Both clinical and neurophysiological outcome suggest that damage done to vastus lateralis either by splitting or elevating appears to be identical


The Journal of Bone & Joint Surgery British Volume
Vol. 89-B, Issue 11 | Pages 1545 - 1550
1 Nov 2007
Koslowsky TC Mader K Dargel J Koebke J Hellmich M Pennig D

We have evaluated four different fixation techniques for the reconstruction of a standard Mason type-III fracture of the radial head in a sawbone model. The outcome measurements were the quality of the reduction, and stability. A total of 96 fractures was created. Six surgeons were involved in the study and each reconstructed 16 fractures with 1.6 mm fine-threaded wires (Fragment Fixation System (FFS)), T-miniplates, 2 mm miniscrews and 2 mm Kirschner (K-) wires; four fractures being allocated to each method using a standard reconstruction procedure. The quality of the reduction was measured after definitive fixation. Biomechanical testing was performed using a transverse plane shear load in two directions to the implants (parallel and perpendicular) with respect to ultimate failure load and displacement at 50 N. A significantly better quality of reduction was achieved using the FFS wires (Tukey’s post hoc tests, p < 0.001) than with the other devices with a mean step in the articular surface and the radial neck of 1.04 mm (. sd. 0.96) for the FFS, 4.25 mm (. sd. 1.29) for the miniplates, 2.21 mm (. sd. 1.06) for the miniscrews and 2.54 mm (. sd. 0.98) for the K-wires. The quality of reduction was similar for K-wires and miniscrews, but poor for miniplates. The ultimate failure load was similar for the FFS wires (parallel, 196.8 N (. sd. 46.8), perpendicular, 212.5 N (. sd. 25.6)), miniscrews (parallel, 211.8 N (. sd. 47.9), perpendicular, 208.0 N (. sd. 65.9)) and K-wires (parallel, 200.4 N (. sd. 54.5), perpendicular, 165.2 N (. sd. 37.9)), but significantly worse (Tukey’s post hoc tests, p < 0.001) for the miniplates (parallel, 101.6 N (. sd. 43.1), perpendicular, 122.7 N (. sd. 40.7)). There was a significant difference in the displacement at 50 N for the miniplate (parallel, 4.8 mm (. sd. 2.8), perpendicular, 4.8 mm (. sd. 1.7)) vs FFS (parallel, 2.1 mm (. sd. 0.8), perpendicular, 1.9 mm (. sd. 0.7)), miniscrews (parallel, 1.8 mm (. sd. 0.5), perpendicular, 2.3 mm (. sd. 0.8)) and K-wires (parallel, 2.2 mm (. sd. 1.8), perpendicular, 2.4 mm (. sd. 0.7; Tukey’s post hoc tests, p < 0.001)). The fixation of a standard Mason type-III fracture in a sawbone model using the FFS system provides a better quality of reduction than that when using conventional techniques. There was a significantly better stability using FFS implants, miniscrews and K-wires than when using miniplates


Bone & Joint Research
Vol. 7, Issue 1 | Pages 36 - 45
1 Jan 2018
Kleinlugtenbelt YV Krol RG Bhandari M Goslings JC Poolman RW Scholtes VAB

Objectives

The patient-rated wrist evaluation (PRWE) and the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire are patient-reported outcome measures (PROMs) used for clinical and research purposes. Methodological high-quality clinimetric studies that determine the measurement properties of these PROMs when used in patients with a distal radial fracture are lacking. This study aimed to validate the PRWE and DASH in Dutch patients with a displaced distal radial fracture (DRF).

Methods

The intraclass correlation coefficient (ICC) was used for test-retest reliability, between PROMs completed twice with a two-week interval at six to eight months after DRF. Internal consistency was determined using Cronbach’s α for the dimensions found in the factor analysis. The measurement error was expressed by the smallest detectable change (SDC). A semi-structured interview was conducted between eight and 12 weeks after DRF to assess the content validity.


Bone & Joint Research
Vol. 3, Issue 5 | Pages 155 - 160
1 May 2014
Carr AJ Rees JL Ramsay CR Fitzpatrick R Gray A Moser J Dawson J Bruhn H Cooper CD Beard DJ Campbell MK

This protocol describes a pragmatic multicentre randomised controlled trial (RCT) to assess the clinical and cost effectiveness of arthroscopic and open surgery in the management of rotator cuff tears. This trial began in 2007 and was modified in 2010, with the removal of a non-operative arm due to high rates of early crossover to surgery.

Cite this article: Bone Joint Res 2014;3:155–60.


Bone & Joint Research
Vol. 2, Issue 2 | Pages 41 - 50
1 Feb 2013
Cottrell JA Keshav V Mitchell A O’Connor JP

Objectives

Recent studies have shown that modulating inflammation-related lipid signalling after a bone fracture can accelerate healing in animal models. Specifically, decreasing 5-lipoxygenase (5-LO) activity during fracture healing increases cyclooxygenase-2 (COX-2) expression in the fracture callus, accelerates chondrogenesis and decreases healing time. In this study, we test the hypothesis that 5-LO inhibition will increase direct osteogenesis.

Methods

Bilateral, unicortical femoral defects were used in rats to measure the effects of local 5-LO inhibition on direct osteogenesis. The defect sites were filled with a polycaprolactone (PCL) scaffold containing 5-LO inhibitor (A-79175) at three dose levels, scaffold with drug carrier, or scaffold only. Drug release was assessed in vitro. Osteogenesis was assessed by micro-CT and histology at two endpoints of ten and 30 days.