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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. Results. No bias in treatment effect was observed overall for the CI site, or the first five sites, compared with the remaining sites in either trial. An early treatment effect on the OSS was observed for the first quintile of participants recruited to ProFHER only (clinically relevant difference of seven points). Selection bias for age was observed in the ProFHER trial only, with slightly younger patients being recruited into the study. Both trials showed some selection bias for markers of poor prognosis, although these did not appear to change over time. Conclusion. No bias in treatment effects overall were found at the CI or early sites set-up. An early treatment effect was found in one of the two trials, which was likely a chance effect as this did not continue during the study. Selection bias was observed in both RCTs, however this was minimal and did not impact on outcome. Cite this article: Bone Jt Open 2023;4(2):96–103


Bone & Joint Open
Vol. 1, Issue 5 | Pages 115 - 120
12 May 2020
Kalstad AM Knobloch RG Finsen V

Aims. To determine if the results of treatment of adolescents with coccydynia are similar to those found in adults. Adult patients with coccydynia may benefit from injection therapy or operative treatment. There is little data evaluating treatment results in adolescents. We have treated adolescent patients similarly to adults and compared the outcomes. Methods. Overall, 32 adolescents with coccydynia were treated at our institution during a seven-year period; 28 responded to final follow-up questionnaires after a minimum of one year, 14 had been treated with only injection therapy, and 14 had been operated with coccygectomy. We collected data with regards to pain while sitting, leaning forward, rising from a sitting position, during defecation, while walking or jogging, and while travelling in trains, planes, or automobiles. Pain at follow-up was registered on a numeric pain scale. Each adolescent was then matched to adult patients, and results compared in a case control fashion. The treatment was considered successful if respondents were either completely well or much better at final follow-up after one to seven years. Results. Out of the 28 treated adolescents, 14 were regarded as successfully treated. Seven were somewhat better, and the remaining seven were unchanged. In the adult control group the corresponding number was 15 successfully treated, eight patients were somewhat better, and five were unchanged. Six of the 14 successfully treated adolescents had been operated. There were no significant differences between the groups in the various registered domains, or on numeric pain scale. Conclusion. Treatment results in adolescent patients seem similar to those in adults. The long-term success rate of injection therapy is low. In case of injection treatment failure, operation may be considered, also in adolescents


Bone & Joint Open
Vol. 1, Issue 9 | Pages 549 - 555
11 Sep 2020
Sonntag J Landale K Brorson S Harris IA

Aims. The aim of this study was to investigate surgeons’ reported change of treatment preference in response to the results and conclusion from a randomized contolled trial (RCT) and to study patterns of change between subspecialties and nationalities. Methods. Two questionnaires were developed through the Delphi process for this cross-sectional survey of surgical preference. The first questionnaire was sent out before the publication of a RCT and the second questionnaire was sent out after publication. The RCT investigated repair or non-repair of the pronator quadratus (PQ) muscle during volar locked plating of distal radial fractures (DRFs). Overall, 380 orthopaedic surgeons were invited to participate in the first questionnaire, of whom 115 replied. One hundred surgeons were invited to participate in the second questionnaire. The primary outcome was the proportion of surgeons for whom a treatment change was warranted, who then reported a change of treatment preference following the RCT. Secondary outcomes included the reasons for repair or non-repair, reasons for and against following the RCT results, and difference of preferred treatment of the PQ muscle between surgeons of different nationalities, qualifications, years of training, and number of procedures performed per year. Results. Of the 100 surgeons invited for the second questionnaire, 74 replied. For the primary outcome, six of 32 surgeons (19%), who usually repaired the PQ muscle and therefore a change of treatment preference was warranted, reported a change of treatment preference based on the RCT publication. Of the secondary outcomes, restoring anatomy was the most common response for repairing the PQ muscle. Conclusion. The majority of the orthopaedic surgeons, where a change of treatment preference was warranted based on the results and conclusion of a RCT, did not report willingness to change their treatment preference. Cite this article: Bone Joint Open 2020;1-9:549–555


Bone & Joint Research
Vol. 3, Issue 7 | Pages 223 - 229
1 Jul 2014
Fleiter N Walter G Bösebeck H Vogt S Büchner H Hirschberger W Hoffmann R

Objective

A clinical investigation into a new bone void filler is giving first data on systemic and local exposure to the anti-infective substance after implantation.

Method

A total of 20 patients with post-traumatic/post-operative bone infections were enrolled in this open-label, prospective study. After radical surgical debridement, the bone cavity was filled with this material. The 21-day hospitalisation phase included determination of gentamicin concentrations in plasma, urine and wound exudate, assessment of wound healing, infection parameters, implant resorption, laboratory parameters, and adverse event monitoring. The follow-up period was six months.


The Bone & Joint Journal
Vol. 104-B, Issue 9 | Pages 1095 - 1100
1 Sep 2022
McNally MA Ferguson JY Scarborough M Ramsden A Stubbs DA Atkins BL

Aims. Excision of chronic osteomyelitic bone creates a dead space which must be managed to avoid early recurrence of infection. Systemic antibiotics cannot penetrate this space in high concentrations, so local treatment has become an attractive adjunct to surgery. The aim of this study was to present the mid- to long-term results of local treatment with gentamicin in a bioabsorbable ceramic carrier. Methods. A prospective series of 100 patients with Cierny-Mader Types III and IV chronic ostemyelitis, affecting 105 bones, were treated with a single-stage procedure including debridement, deep tissue sampling, local and systemic antibiotics, stabilization, and immediate skin closure. Chronic osteomyelitis was confirmed using strict diagnostic criteria. The mean follow-up was 6.05 years (4.2 to 8.4). Results. At final follow-up, six patients (six bones) had recurrent infection; thus 94% were infection-free. Three infections recurred in the first year, two in the second year, and one 4.5 years postoperatively. Recurrence was not significantly related to the physiological class of the patient (1/20 Class A (5%) vs 5/80 Class B (6.25%); p = 0.833), nor was it significantly related to the aetiology of the infection, the organisms which were cultured or the presence of nonunion before surgery (1/10 with nonunion (10%) vs 5/90 without nonunion (5.6%); p = 0.570). Organisms with intermediate or high-grade resistance to gentamicin were significantly more likely in polymicrobial infections (9/21; 42.8%) compared with monobacterial osteomyelitis (7/79 (8.9%); p < 0.001). However, recurrence was not significantly more frequent when a resistant organism was present (1/16 for resistant cases (6.25%) vs 5/84 in those with a microbiologically sensitive infection (5.95%); p = 0.958). Conclusion. We found that a single-stage protocol, including the use of a high-delivery local antibiotic ceramic carrier, was effective over a period of several years. The method can be used in a wide range of patients, including those with significant comorbidities and an infected nonunion. Cite this article: Bone Joint J 2022;104-B(9):1095–1100


Bone & Joint Open
Vol. 5, Issue 9 | Pages 721 - 728
1 Sep 2024
Wetzel K Clauss M Joeris A Kates S Morgenstern M

Aims. It is well described that patients with bone and joint infections (BJIs) commonly experience significant functional impairment and disability. Published literature is lacking on the impact of BJIs on mental health. Therefore, the aim of this study was to assess health-related quality of life (HRQoL) and the impact on mental health in patients with BJIs. Methods. The AO Trauma Infection Registry is a prospective multinational registry. In total, 229 adult patients with long-bone BJI were enrolled between 1 November 2012 and 31 August 2017 in 18 centres from ten countries. Clinical outcome data, demographic data, and details on infections and treatments were collected. Patient-reported outcomes using the 36-Item Short-Form Health Survey questionnaire (SF-36), Parker Mobility Score, and Katz Index of Independence in Activities of Daily Living were assessed at one, six, and 12 months. The SF-36 mental component subscales were analyzed and correlated with infection characteristics and clinical outcome. Results. The SF-36 physical component summary mean at baseline was 30.9 (95% CI 29.7 to 32.0). At one month, it was unchanged (30.5; 95% CI 29.5 to 31.5; p = 0.447); it had improved statistically significantly at six months (35.5; 95% CI 34.2 to 36.7; p < 0.001) and at 12 months (37.9; 95% CI 36.4 to 39.3; p < 0.001). The SF-36 mental component summary mean at baseline was 42.5 (95% CI 40.8 to 44.2). At one month, it was unchanged (43.1; 95% CI 41.4 to 44.8; p = 0.458); it had improved statistically significantly at six months (47.1; 95% CI 45.4 to 48.7; p < 0.001) and at 12 months (46.7; 95% CI 45.0 to 48.5; p < 0.001). All mental subscales had improved by the end of the study, but mental health status remained compromised in comparison with the average USA population. Conclusion. BJIs considerably impact HRQoL, particularly mental health. Patients suffering from BJIs reported considerable limitations in their daily and social activities due to psychological problems. Impaired mental health may be explained by the chronic nature of BJIs, and therefore the mental wellbeing of these patients should be monitored closely. Cite this article: Bone Jt Open 2024;5(9):721–728


Bone & Joint Open
Vol. 3, Issue 5 | Pages 359 - 366
1 May 2022
Sadekar V Watts AT Moulder E Souroullas P Hadland Y Barron E Muir R Sharma HK

Aims. The timing of when to remove a circular frame is crucial; early removal results in refracture or deformity, while late removal increases the patient morbidity and delay in return to work. This study was designed to assess the effectiveness of a staged reloading protocol. We report the incidence of mechanical failure following both single-stage and two stage reloading protocols and analyze the associated risk factors. Methods. We identified consecutive patients from our departmental database. Both trauma and elective cases were included, of all ages, frame types, and pathologies who underwent circular frame treatment. Our protocol is either a single-stage or two-stage process implemented by defunctioning the frame, in order to progressively increase the weightbearing load through the bone, and promote full loading prior to frame removal. Before progression, through the process we monitor patients for any increase in pain and assess radiographs for deformity or refracture. Results. There were 244 frames (230 patients) included in the analyses, of which 90 were Ilizarov type frames and 154 were hexapods. There were 149 frames which underwent single-stage reloading and 95 frames which underwent a two-stage reloading protocol. Mechanical failure occurred after frame removal in 13 frames (5%), which suffered refracture. There were no cases of change in alignment. There was no difference between refracture patients who underwent single-stage or two-stage reloading protocols (p = 0.772). In all, 14 patients had failure prevented through identification with the reloading protocol. Conclusion. Our reloading protocol is a simple and effective way to confirm the timing of frame removal and minimize the rate of mechanical failure. Similar failure rates occurred between patients undergoing single-stage and two-stage reloading protocols. If the surgeon is confident with clinical and radiological assessment, it may be possible to progress directly to stage two and decrease frame time and patient morbidity. Cite this article: Bone Jt Open 2022;3(5):359–366


Bone & Joint Open
Vol. 3, Issue 5 | Pages 432 - 440
1 May 2022
Craig AD Asmar S Whitaker P Shaw DL Saralaya D

Aims. Tuberculosis (TB) is one of the biggest communicable causes of mortality worldwide. While incidence in the UK has continued to fall since 2011, Bradford retains one of the highest TB rates in the UK. This study aims to examine the local disease burden of musculoskeletal (MSK) TB, by analyzing common presenting factors within the famously diverse population of Bradford. Methods. An observational study was conducted, using data from the Bradford Teaching Hospitals TB database of patients with a formal diagnosis of MSK TB between January 2005 and July 2017. Patient data included demographic data (including nationality/date of entry to the UK), disease focus, microbiology, and management strategies. Disease incidence was calculated using population data from the Office for National Statistics. Poisson confidence intervals were calculated to demonstrate the extent of statistical error. Disease incidence and nationality were also analyzed, and correlation sought, using the chi-squared test. Results. Between January 2005 and July 2017, 109 cases of MSK TB were diagnosed in Bradford. Mean incidence was 1.65 per 100,000 population, per calendar year (SD 0.75). A total of 38 cases required surgical intervention. Low rates of antimicrobial resistance were encountered. A low rate of loss to follow-up was observed (four patients; 3.7%). Overall, 94.5% of patients (n = 103) were successfully treated. 67% of patients (n = 73) reported their country of origin as either India, Pakistan, or Bangladesh. These ethnicities account for around 25% of the local population. Conclusion. Bradford maintains a high prevalence of MSK TB infection relative to national data; the prevalence within the local immigrant population remains grossly disproportionate. Typical associated factors (HIV/hepatitis coinfection, drug resistance), have only modest prevalence in our dataset. However, local socioeconomic factors such as deprivation and poverty appear germane as suggested by global literature. We advocate a high degree of suspicion in treatment of atypical infection in any area with similar population factors to ensure timely diagnosis. Cite this article: Bone Jt Open 2022;3(5):432–440


Bone & Joint Research
Vol. 13, Issue 8 | Pages 411 - 426
28 Aug 2024
Liu D Wang K Wang J Cao F Tao L

Aims

This study explored the shared genetic traits and molecular interactions between postmenopausal osteoporosis (POMP) and sarcopenia, both of which substantially degrade elderly health and quality of life. We hypothesized that these motor system diseases overlap in pathophysiology and regulatory mechanisms.

Methods

We analyzed microarray data from the Gene Expression Omnibus (GEO) database using weighted gene co-expression network analysis (WGCNA), machine learning, and Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment analysis to identify common genetic factors between POMP and sarcopenia. Further validation was done via differential gene expression in a new cohort. Single-cell analysis identified high expression cell subsets, with mononuclear macrophages in osteoporosis and muscle stem cells in sarcopenia, among others. A competitive endogenous RNA network suggested regulatory elements for these genes.


Bone & Joint Open
Vol. 4, Issue 3 | Pages 146 - 157
7 Mar 2023
Camilleri-Brennan J James S McDaid C Adamson J Jones K O'Carroll G Akhter Z Eltayeb M Sharma H

Aims

Chronic osteomyelitis (COM) of the lower limb in adults can be surgically managed by either limb reconstruction or amputation. This scoping review aims to map the outcomes used in studies surgically managing COM in order to aid future development of a core outcome set.

Methods

A total of 11 databases were searched. A subset of studies published between 1 October 2020 and 1 January 2011 from a larger review mapping research on limb reconstruction and limb amputation for the management of lower limb COM were eligible. All outcomes were extracted and recorded verbatim. Outcomes were grouped and categorized as per the revised Williamson and Clarke taxonomy.


Bone & Joint Open
Vol. 4, Issue 8 | Pages 643 - 651
24 Aug 2023
Langit MB Tay KS Al-Omar HK Barlow G Bates J Chuo CB Muir R Sharma H

Aims

The standard of wide tumour-like resection for chronic osteomyelitis (COM) has been challenged recently by adequate debridement. This paper reviews the evolution of surgical debridement for long bone COM, and presents the outcome of adequate debridement in a tertiary bone infection unit.

Methods

We analyzed the retrospective record review from 2014 to 2020 of patients with long bone COM. All were managed by multidisciplinary infection team (MDT) protocol. Adequate debridement was employed for all cases, and no case of wide resection was included.


Bone & Joint Open
Vol. 3, Issue 10 | Pages 777 - 785
10 Oct 2022
Kulkarni K Shah R Mangwani J Dias J

Aims

Deprivation underpins many societal and health inequalities. COVID-19 has exacerbated these disparities, with access to planned care falling greatest in the most deprived areas of the UK during 2020. This study aimed to identify the impact of deprivation on patients on growing waiting lists for planned care.

Methods

Questionnaires were sent to orthopaedic waiting list patients at the start of the UK’s first COVID-19 lockdown to capture key quantitative and qualitative aspects of patients’ health. A total of 888 respondents were divided into quintiles, with sampling stratified based on the Index of Multiple Deprivation (IMD); level 1 represented the ‘most deprived’ cohort and level 5 the ‘least deprived’.


Bone & Joint Open
Vol. 4, Issue 9 | Pages 704 - 712
14 Sep 2023
Mercier MR Koucheki R Lex JR Khoshbin A Park SS Daniels TR Halai MM

Aims

This study aimed to investigate the risk of postoperative complications in COVID-19-positive patients undergoing common orthopaedic procedures.

Methods

Using the National Surgical Quality Improvement Programme (NSQIP) database, patients who underwent common orthopaedic surgery procedures from 1 January to 31 December 2021 were extracted. Patient preoperative COVID-19 status, demographics, comorbidities, type of surgery, and postoperative complications were analyzed. Propensity score matching was conducted between COVID-19-positive and -negative patients. Multivariable regression was then performed to identify both patient and provider risk factors independently associated with the occurrence of 30-day postoperative adverse events.


Bone & Joint Open
Vol. 2, Issue 9 | Pages 705 - 709
1 Sep 2021
Wright J Timms A Fugazzotto S Goodier D Calder P

Aims. Patients undergoing limb reconstruction surgery often face a challenging and lengthy process to complete their treatment journey. The majority of existing outcome measures do not adequately capture the patient-reported outcomes relevant to this patient group in a single measure. Following a previous systematic review, the Stanmore Limb Reconstruction Score (SLRS) was designed with the intent to address this need for an effective instrument to measure patient-reported outcomes in limb reconstruction patients. We aim to assess the face validity of this score in a pilot study. Methods. The SLRS was designed following structured interviews with several groups including patients who have undergone limb reconstruction surgery, limb reconstruction surgeons, specialist nurses, and physiotherapists. This has subsequently undergone further adjustment for language and clarity. The score was then trialled on ten patients who had undergone limb reconstruction surgery, with subsequent structured questioning to understand the perceived suitability of the score. Results. Ten patients completed the score and the subsequent structured interview. Considering the tool as a whole, 100% of respondents felt the score to be comprehensible, relevant, and comprehensive regarding the areas that were important to a patient undergoing limb reconstruction surgery. For individual questions, on a five-point Likert scale, importance/relevance was reported as a mean of 4.78 (4.3 to 5.0), with ability to understand rated as 4.92 (4.7 to 5.0) suggesting high levels of relevance and comprehension. Flesch-Kincaid reading grade level was calculated as 5.2 (10 to 11 years old). Conclusion. The current SLRS has been shown to have acceptable scores from a patient sample regarding relevance, comprehensibility, and comprehensiveness. This suggests face validity, however further testing required and is ongoing in a larger cohort of patients to determine the reliability, responsiveness, precision, and criterion validity of the score in this patient group. Cite this article: Bone Jt Open 2021;2(9):705–709


Bone & Joint Open
Vol. 4, Issue 7 | Pages 539 - 550
21 Jul 2023
Banducci E Al Muderis M Lu W Bested SR

Aims

Safety concerns surrounding osseointegration are a significant barrier to replacing socket prosthesis as the standard of care following limb amputation. While implanted osseointegrated prostheses traditionally occur in two stages, a one-stage approach has emerged. Currently, there is no existing comparison of the outcomes of these different approaches. To address safety concerns, this study sought to determine whether a one-stage osseointegration procedure is associated with fewer adverse events than the two-staged approach.

Methods

A comprehensive electronic search and quantitative data analysis from eligible studies were performed. Inclusion criteria were adults with a limb amputation managed with a one- or two-stage osseointegration procedure with follow-up reporting of complications.


Bone & Joint Open
Vol. 4, Issue 9 | Pages 696 - 703
11 Sep 2023
Ormond MJ Clement ND Harder BG Farrow L Glester A

Aims

The principles of evidence-based medicine (EBM) are the foundation of modern medical practice. Surgeons are familiar with the commonly used statistical techniques to test hypotheses, summarize findings, and provide answers within a specified range of probability. Based on this knowledge, they are able to critically evaluate research before deciding whether or not to adopt the findings into practice. Recently, there has been an increased use of artificial intelligence (AI) to analyze information and derive findings in orthopaedic research. These techniques use a set of statistical tools that are increasingly complex and may be unfamiliar to the orthopaedic surgeon. It is unclear if this shift towards less familiar techniques is widely accepted in the orthopaedic community. This study aimed to provide an exploration of understanding and acceptance of AI use in research among orthopaedic surgeons.

Methods

Semi-structured in-depth interviews were carried out on a sample of 12 orthopaedic surgeons. Inductive thematic analysis was used to identify key themes.


Bone & Joint Open
Vol. 3, Issue 10 | Pages 786 - 794
12 Oct 2022
Harrison CJ Plummer OR Dawson J Jenkinson C Hunt A Rodrigues JN

Aims

The aim of this study was to develop and evaluate machine-learning-based computerized adaptive tests (CATs) for the Oxford Hip Score (OHS), Oxford Knee Score (OKS), Oxford Shoulder Score (OSS), and the Oxford Elbow Score (OES) and its subscales.

Methods

We developed CAT algorithms for the OHS, OKS, OSS, overall OES, and each of the OES subscales, using responses to the full-length questionnaires and a machine-learning technique called regression tree learning. The algorithms were evaluated through a series of simulation studies, in which they aimed to predict respondents’ full-length questionnaire scores from only a selection of their item responses. In each case, the total number of items used by the CAT algorithm was recorded and CAT scores were compared to full-length questionnaire scores by mean, SD, score distribution plots, Pearson’s correlation coefficient, intraclass correlation (ICC), and the Bland-Altman method. Differences between CAT scores and full-length questionnaire scores were contextualized through comparison to the instruments’ minimal clinically important difference (MCID).


Bone & Joint Open
Vol. 2, Issue 8 | Pages 583 - 593
2 Aug 2021
Kulkarni K Shah R Armaou M Leighton P Mangwani J Dias J

Aims. COVID-19 has compounded a growing waiting list problem, with over 4.5 million patients now waiting for planned elective care in the UK. Views of patients on waiting lists are rarely considered in prioritization. Our primary aim was to understand how to support patients on waiting lists by hearing their experiences, concerns, and expectations. The secondary aim was to capture objective change in disability and coping mechanisms. Methods. A minimum representative sample of 824 patients was required for quantitative analysis to provide a 3% margin of error. Sampling was stratified by body region (upper/lower limb, spine) and duration on the waiting list. Questionnaires were sent to a random sample of elective orthopaedic waiting list patients with their planned intervention paused due to COVID-19. Analyzed parameters included baseline health, change in physical/mental health status, challenges and coping strategies, preferences/concerns regarding treatment, and objective quality of life (EuroQol five-dimension questionnaire (EQ-5D), Generalized Anxiety Disorder 2-item scale (GAD-2)). Qualitative analysis was performed via the Normalization Process Theory. Results. A total of 888 patients responded. Better health, pain, and mood scores were reported by upper limb patients. The longest waiters reported better health but poorer mood and anxiety scores. Overall, 82% had tried self-help measures to ease symptoms; 94% wished to proceed with their intervention; and 21% were prepared to tolerate deferral. Qualitative analysis highlighted the overall patient mood to be represented by the terms ‘understandable’, ‘frustrated’, ‘pain’, ‘disappointed’, and ‘not happy/depressed’. COVID-19-mandated health and safety measures and technology solutions were felt to be implemented well. However, patients struggled with access to doctors and pain management, quality of life (physical and psychosocial) deterioration, and delay updates. Conclusion. This is the largest study to hear the views of this ‘hidden’ cohort. Our findings are widely relevant to ensure provision of better ongoing support and communication, mostly within the constraints of current resources. In response, we developed a reproducible local action plan to address highlighted issues. Cite this article: Bone Jt Open 2021;2(8):583–593


Bone & Joint Research
Vol. 10, Issue 7 | Pages 425 - 436
16 Jul 2021
Frommer A Roedl R Gosheger G Hasselmann J Fuest C Toporowski G Laufer A Tretow H Schulze M Vogt B

Aims. This study aims to enhance understanding of clinical and radiological consequences and involved mechanisms that led to corrosion of the Precice Stryde (Stryde) intramedullary lengthening nail in the post market surveillance era of the device. Between 2018 and 2021 more than 2,000 Stryde nails have been implanted worldwide. However, the outcome of treatment with the Stryde system is insufficiently reported. Methods. This is a retrospective single-centre study analyzing outcome of 57 consecutive lengthening procedures performed with the Stryde nail at the authors’ institution from February 2019 until November 2020. Macro- and microscopic metallographic analysis of four retrieved nails was conducted. To investigate observed corrosion at telescoping junction, scanning electron microscopy (SEM) and energy dispersive x-ray spectroscopy (EDX) were performed. Results. Adjacent to the nail’s telescoping junction, osteolytic changes were observed in bi-planar radiographs of 20/57 segments (35%) after a mean of 9.5 months (95% confidence interval 7.2 to 11.9) after surgery. A total of 8/20 patients with osseous alterations (40%) reported rest and ambulation pain of the lengthened segment during consolidation. So far, 24 Stryde nails were retrieved and in 20 (83%) macroscopic corrosion was observed at the nail’s telescoping junction. Before implant removal 11/20 radiographs (55%) of lengthened segments with these 20 nails revealed osteolysis. Implant retrieval analysis by means of SEM showed pitting and crevice corrosion. EDX detected chromium as the main metallic element of corrosion. Conclusion. Patients are exposed to the risk of implant-related osteolysis of unclear short- and long-term clinical consequences. The authors advocate in favour of an early implant removal after osseous consolidation. Cite this article: Bone Joint Res 2021;10(7):425–436


Bone & Joint Open
Vol. 2, Issue 8 | Pages 599 - 610
1 Aug 2021
Hothi H Bergiers S Henckel J Iliadis AD Goodier WD Wright J Skinner J Calder P Hart AJ

Aims. The aim of this study was to present the first retrieval analysis findings of PRECICE STRYDE intermedullary nails removed from patients, providing useful information in the post-market surveillance of these recently introduced devices. Methods. We collected ten nails removed from six patients, together with patient clinical data and plain radiograph imaging. We performed macro- and microscopic analysis of all surfaces and graded the presence of corrosion using validated semiquantitative scoring methods. We determined the elemental composition of surface debris using energy dispersive x-ray spectroscopy (EDS) and used metrology analysis to characterize the surface adjacent to the extendable junctions. Results. All nails were removed at the end of treatment, having achieved their intended lengthening (20 mm to 65 mm) and after regenerate consolidation. All nails had evidence of corrosion localized to the screw holes and the extendable junctions; corrosion was graded as moderate at the junction of one nail and severe at the junctions of five nails. EDS analysis showed surface deposits to be chromium rich. Plain radiographs showed cortical thickening and osteolysis around the junction of six nails, corresponding to the same nails with moderate – severe junction corrosion. Conclusion. We found, in fully united bones, evidence of cortical thickening and osteolysis that appeared to be associated with corrosion at the extendable junction; when corrosion was present, cortical thickening was adjacent to this junction. Further work, with greater numbers of retrievals, is required to fully understand this association between corrosion and bony changes, and the influencing surgeon, implant, and patient factors involved. Cite this article: Bone Jt Open 2021;2(8):599–610