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Bone & Joint Open
Vol. 1, Issue 5 | Pages 121 - 130
13 May 2020
Crosby BT Behbahani A Olujohungbe O Cottam B Perry D

Objectives. This review aims to summarize the outcomes used to describe effectiveness of treatments for paediatric wrist fractures within existing literature. Method. We searched the Cochrane Library, Scopus, and Ovid Medline for studies pertaining to paediatric wrist fractures. Three authors independently identified and reviewed eligible studies. This resulted in a list of outcome domains and outcomes measures used within clinical research. Outcomes were mapped onto domains defined by the COMET collaborative. Results. Our search terms identified 4,262 different papers. Screening of titles excluded 2,975, leaving 1,287 papers to be assessed for eligibility. Of this 1,287, 30 studies were included for full analysis. Overall, five outcome domains, 16 outcome measures, and 28 measurement instruments were identified as outcomes within these studies. 24 studies used at least one measurement pertaining to the physiological/clinical outcome domain. The technical, life impact, and adverse effect domains were recorded in 23, 20, and 11 of the studies respectively. Within each domain it was common for different measurement instruments to be used to assess each outcome measure. The most commonly reported outcome measures were range of movement, a broad array of “radiological measures” and pain intensity, which were used in 24, 23, and 12 of the 30 studies. Conclusion. This study highlights the heterogeneity in outcomes reported within clinical effectiveness studies of paediatric wrist fractures. We provided an overview of the types of outcomes reported in paediatric wrist fracture studies and identified a list of potentially relevant outcomes required for the development of a core outcome set


Bone & Joint Research
Vol. 12, Issue 4 | Pages 294 - 305
20 Apr 2023
Aquilina AL Claireaux H Aquilina CO Tutton E Fitzpatrick R Costa ML Griffin XL

Aims. Open lower limb fracture is life-changing, resulting in substantial morbidity and resource demand, while inconsistent outcome-reporting hampers systematic review and meta-analysis. A core outcome set establishes consensus among key stakeholders for the recommendation of a minimum set of outcomes. This study aims to define a core outcome set for adult open lower limb fracture. Methods. Candidate outcomes were identified from a previously published systematic review and a secondary thematic analysis of 25 patient interviews exploring the lived experience of recovery from open lower limb fracture. Outcomes were categorized and sequentially refined using healthcare professional and patient structured discussion groups. Consensus methods included a multi-stakeholder two-round online Delphi survey and a consensus meeting attended by a purposive sample of stakeholders, facilitated discussion, and voting using a nominal group technique. Results. Thematic analysis and systematic review identified 121 unique outcomes, reduced to 68 outcomes following structured discussion groups. Outcomes were presented to 136 participants who completed a two-round online Delphi survey. The Delphi survey resulted in 11 outcomes identified as consensus ‘in’ only. All outcomes were discussed at a consensus meeting attended by 15 patients, 14 healthcare professionals, 11 researchers, and one patient-carer. Consensus was achieved for a four-core outcome set: ‘Walking, gait and mobility’, ‘Being able to return to life roles’, ‘Pain or discomfort’, and ‘Quality of life’. Conclusion. This study used robust consensus methods to establish a core outcome set that should be measured in all future research studies and audits of clinical practice without precluding the measurement of additional outcomes. Cite this article: Bone Joint Res 2023;12(4):294–305


Bone & Joint Research
Vol. 12, Issue 6 | Pages 352 - 361
1 Jun 2023
Aquilina AL Claireaux H Aquilina CO Tutton E Fitzpatrick R Costa ML Griffin XL

Aims. A core outcome set for adult, open lower limb fracture has been established consisting of ‘Walking, gait and mobility’, ‘Being able to return to life roles’, ‘Pain or discomfort’, and ‘Quality of life’. This study aims to identify which outcome measurement instruments (OMIs) should be recommended to measure each core outcome. Methods. A systematic review and quality assessment were conducted to identify existing instruments with evidence of good measurement properties in the open lower limb fracture population for each core outcome. Additionally, shortlisting criteria were developed to identify suitable instruments not validated in the target population. Candidate instruments were presented, discussed, and voted on at a consensus meeting of key stakeholders. Results. The Wales Lower Limb Trauma Recovery scale was identified, demonstrating validation evidence in the target population. In addition, ten candidate OMIs met the shortlisting criteria. Six patients, eight healthcare professionals, and 11 research methodologists attended the consensus meeting. Consensus was achieved for the EuroQol five-dimension five-level questionnaire (EQ-5D-5L) and the Lower Extremity Functional Scale (LEFS) to measure ‘Quality of life’ and ‘Walking, gait and mobility’ in future research trials, audit, and clinical assessment, respectively. No instrument met consensus criteria to measure ‘Being able to return to life roles’ and ‘Pain or discomfort’. However, the EQ-5D-5L was found to demonstrate good face validity and could also be used pragmatically to measure these two outcomes, accepting limitations in sensitivity. Conclusion. This study recommends the LEFS and EQ-5D-5L to measure the core outcome set for adult open lower limb fracture. Cite this article: Bone Joint Res 2023;12(6):352–361


Bone & Joint Open
Vol. 3, Issue 10 | Pages 804 - 814
13 Oct 2022
Grammatopoulos G Laboudie P Fischman D Ojaghi R Finless A Beaulé PE

Aims. The primary aim of this study was to determine the ten-year outcome following surgical treatment for femoroacetabular impingement (FAI). We assessed whether the evolution of practice from open to arthroscopic techniques influenced outcomes and tested whether any patient, radiological, or surgical factors were associated with outcome. Methods. Prospectively collected data of a consecutive single-surgeon cohort, operated for FAI between January 2005 and January 2015, were retrospectively studied. The cohort comprised 393 hips (365 patients; 71% male (n = 278)), with a mean age of 34.5 years (SD 10.0). Over the study period, techniques evolved from open surgical dislocation (n = 94) to a combined arthroscopy-Hueter technique (HA + Hueter; n = 61) to a pure arthroscopic technique (HA; n = 238). Outcome measures of interest included modes of failures, complications, reoperation, and patient-reported outcome measures (PROMs). Demographic, radiological, and surgical factors were tested for possible association with outcome. Results. At a mean follow-up of 7.5 years (SD 2.5), there were 43 failures in 38 hips (9.7%), with 35 hips (8.9%) having one failure mode, one hip (0.25%) having two failure modes, and two hips (0.5%) having three failure modes. The five- and ten-year hip joint preservation rates were 94.1% (SD 1.2%; 95% confidence interval (CI) 91.8 to 96.4) and 90.4% (SD 1.7%; 95% CI 87.1 to 93.7), respectively. Inferior survivorship was detected in the surgical dislocation group. Age at surgery, Tönnis grade, cartilage damage, and absence of rim-trimming were associated with improved preservation rates. Only Tönnis grade was an independent predictor of hip preservation. All PROMs improved postoperatively. Factors associated with improvement in PROMs included higher lateral centre-edge and α angles, and lower retroversion index and BMI. Conclusion. FAI surgery provides lasting improvement in function and a joint preservation rate of 90.4% at ten years. The evolution of practice was not associated with inferior outcome. Since degree of arthritis is the primary predictor of outcome, improved awareness and screening may lead to prompt intervention and better outcomes. Cite this article: Bone Jt Open 2022;3(10):804–814


Bone & Joint Research
Vol. 12, Issue 2 | Pages 138 - 146
14 Feb 2023
Aquilina AL Claireaux H Aquilina CO Tutton E Fitzpatrick R Costa ML Griffin XL

Aims. Open lower limb fracture is a life-changing injury affecting 11.5 per 100,000 adults each year, and causes significant morbidity and resource demand on trauma infrastructures. This study aims to identify what, and how, outcomes have been reported for people following open lower limb fracture over ten years. Methods. Systematic literature searches identified all clinical studies reporting outcomes for adults following open lower limb fracture between January 2009 and July 2019. All outcomes and outcome measurement instruments were extracted verbatim. An iterative process was used to group outcome terms under standardized outcome headings categorized using an outcome taxonomy. Results. A total of 532 eligible studies were identified, reporting 1,803 outcomes with 786 unique outcome terms, which collapsed to 82 standardized outcome headings. Overall 479 individual outcome measurement instruments were identified, including 298 outcome definitions, 27 patient- and 18 clinician-reported outcome measures, and six physical performance measures. The most-reported outcome was ‘bone union/healing’ reported in over 50% of included studies, while health-related quality of life was only measured in 6% of included studies. Conclusion. Outcomes reported for people recovering from open lower limb fracture are heterogeneous, liable to outcome reporting bias, and vary widely in the definitions and the measurement tools used to collect them. Outcomes likely to be important to patients, such as quality of life and measures of physical functioning, have been neglected. This systematic review identifies the need to unify outcome measures reported on patients recovering from open lower limb fracture; this may be addressed by creating a core outcome set. Cite this article: Bone Joint Res 2023;12(2):138–146


Bone & Joint Open
Vol. 5, Issue 10 | Pages 911 - 919
21 Oct 2024
Clement N MacDonald DJ Hamilton DF Gaston P

Aims. The aims were to assess whether joint-specific outcome after total knee arthroplasty (TKA) was influenced by implant design over a 12-year follow-up period, and whether patient-related factors were associated with loss to follow-up and mortality risk. Methods. Long-term follow-up of a randomized controlled trial was undertaken. A total of 212 patients were allocated a Triathlon or a Kinemax TKA. Patients were assessed preoperatively, and one, three, eight, and 12 years postoperatively using the Oxford Knee Score (OKS). Reasons for patient lost to follow-up, mortality, and revision were recorded. Results. A total of 94 patients completed 12-year functional follow-up (62 females, mean age 66 years (43 to 82) at index surgery). There was a clinically significantly greater improvement in the OKS at one year (mean difference (MD) 3.0 (95% CI 0.4 to 5.7); p = 0.027) and three years (MD 4.7 (95% CI 1.9 to 7.5); p = 0.001) for the Triathlon group, but no differences were observed at eight (p = 0.331) or 12 years’ (p = 0.181) follow-up. When assessing the OKS in the patients surviving to 12 years, the Triathlon group had a clinically significantly greater improvement in the OKS (marginal mean 3.8 (95% CI 0.2 to 7.4); p = 0.040). Loss to functional follow-up (53%, n = 109/204) was independently associated with older age (p = 0.001). Patient mortality was the major reason (56.4%, n = 62/110) for loss to follow-up. Older age (p < 0.001) and worse preoperative OKS (p = 0.043) were independently associated with increased mortality risk. An age at time of surgery of ≥ 72 years was 75% sensitive and 74% specific for predicting mortality with an area under the curve of 78.1% (95% CI 70.9 to 85.3; p < 0.001). Conclusion. The Triathlon TKA was associated with clinically meaningful greater improvement in knee-specific outcome when compared to the Kinemax TKA. Loss to follow-up at 12 years was a limitation, and studies planning longer-term functional assessment could limit their cohort to patients aged under 72 years. Cite this article: Bone Jt Open 2024;5(10):911–919


The Bone & Joint Journal
Vol. 105-B, Issue 4 | Pages 422 - 430
15 Mar 2023
Riksaasen AS Kaur S Solberg TK Austevoll I Brox J Dolatowski FC Hellum C Kolstad F Lonne G Nygaard ØP Ingebrigtsen T

Aims. Repeated lumbar spine surgery has been associated with inferior clinical outcomes. This study aimed to examine and quantify the impact of this association in a national clinical register cohort. Methods. This is a population-based study from the Norwegian Registry for Spine surgery (NORspine). We included 26,723 consecutive cases operated for lumbar spinal stenosis or lumbar disc herniation from January 2007 to December 2018. The primary outcome was the Oswestry Disability Index (ODI), presented as the proportions reaching a patient-acceptable symptom state (PASS; defined as an ODI raw score ≤ 22) and ODI raw and change scores at 12-month follow-up. Secondary outcomes were the Global Perceived Effect scale, the numerical rating scale for pain, the EuroQoL five-dimensions health questionnaire, occurrence of perioperative complications and wound infections, and working capability. Binary logistic regression analysis was conducted to examine how the number of previous operations influenced the odds of not reaching a PASS. Results. The proportion reaching a PASS decreased from 66.0% (95% confidence interval (CI) 65.4 to 66.7) in cases with no previous operation to 22.0% (95% CI 15.2 to 30.3) in cases with four or more previous operations (p < 0.001). The odds of not reaching a PASS were 2.1 (95% CI 1.9 to 2.2) in cases with one previous operation, 2.6 (95% CI 2.3 to 3.0) in cases with two, 4.4 (95% CI 3.4 to 5.5) in cases with three, and 6.9 (95% CI 4.5 to 10.5) in cases with four or more previous operations. The ODI raw and change scores and the secondary outcomes showed similar trends. Conclusion. We found a dose-response relationship between increasing number of previous operations and inferior outcomes among patients operated for degenerative conditions in the lumbar spine. This information should be considered in the shared decision-making process prior to elective spine surgery. Cite this article: Bone Joint J 2023;105-B(4):422–430


The Bone & Joint Journal
Vol. 103-B, Issue 12 | Pages 1821 - 1830
1 Dec 2021
Marson BA Manning JC James M Craxford S Deshmukh SR Perry DC Ollivere BJ

Aims. The aim of this study is to develop a core set of outcome domains that should be considered and reported in all future trials of childhood limb fractures. Methods. A four-phase study was conducted to agree a set of core outcome domains. Identification of candidate outcome domains were identified through systematic review of trials, and outcome domains relevant to families were identified through semi-structured interviews with 20 families (parent-child pairing or group). Outcome domains were prioritized using an international three-round Delphi survey with 205 panellists and then condensed into a core outcome set through a consensus workshop with 30 stakeholders. Results. The systematic review and interviews identified 85 outcome domains as relevant to professionals or families. The Delphi survey prioritized 30 upper and 29 lower limb outcome domains at first round, an additional 17 upper and 18 lower limb outcomes at second round, and four additional outcomes for upper and lower limb at the third round as important domains. At the consensus workshop, the core outcome domains were agreed as: 1) pain and discomfort; 2) return to physical and recreational activities; 3) emotional and psychosocial wellbeing; 4) complications from the injury and treatment; 5) rturn to baseline activities daily living; 6) participation in learning; 7) appearance and deformity; and 8) time to union. In addition, 9a) recovery of mobility and 9b) recovery of manual dexterity was recommended as a core outcome for lower and upper limb fractures, respectively. Conclusion. This set of core outcome domains is recommended as a minimum set of outcomes to be reported in all trials. It is not an exhaustive set and further work is required to identify what outcome tools should be used to measure each of these outcomes. Adoption of this outcome set will improve the consistency of research for these children that can be combined for more meaningful meta-analyses and policy development. Cite this article: Bone Joint J 2021;103-B(12):1821–1830


The Bone & Joint Journal
Vol. 106-B, Issue 10 | Pages 1050 - 1058
1 Oct 2024
Holleyman RJ Jameson SS Meek RMD Khanduja V Reed MR Judge A Board TN

Aims. This study evaluates the association between consultant and hospital volume and the risk of re-revision and 90-day mortality following first-time revision of primary hip arthroplasty for aseptic loosening. Methods. We conducted a cohort study of first-time, single-stage revision hip arthroplasties (RHAs) performed for aseptic loosening and recorded in the National Joint Registry (NJR) data for England, Wales, Northern Ireland, and the Isle of Man between 2003 and 2019. Patient identifiers were used to link records to national mortality data, and to NJR data to identify subsequent re-revision procedures. Multivariable Cox proportional hazard models with restricted cubic splines were used to define associations between volume and outcome. Results. Among 12,961 RHAs there were 513 re-revisions within two years, and 95 deaths within 90 days of surgery. The risk of re-revision was highest for a consultant’s first RHA (hazard ratio (HR) 1.56 (95% CI 1.15 to 2.12)) and remained significantly elevated for their first 24 cases (HR 1.26 (95% CI 1.00 to 1.58)). Annual consultant volumes of five/year were associated with an almost 30% greater risk of re-revision (HR 1.28 (95% CI 1.00 to 1.64)) and 80% greater risk of 90-day mortality (HR 1.81 (95% CI 1.02 to 3.21)) compared to volumes of 20/year. RHAs performed at hospitals which had cumulatively undertaken fewer than 167 RHAs were at up to 70% greater risk of re-revision (HR 1.70 (95% CI 1.12 to 2.59)), and those having undertaken fewer than 307 RHAs were at up to three times greater risk of 90-day mortality (HR 3.05 (95% CI 1.19 to 7.82)). Conclusion. This study found a significantly higher risk of re-revision and early postoperative mortality following first-time single-stage RHA for aseptic loosening when performed by lower-volume consultants and at lower-volume institutions, supporting the move towards the centralization of such cases towards higher-volume units and surgeons. Cite this article: Bone Joint J 2024;106-B(10):1050–1058


Bone & Joint Open
Vol. 3, Issue 1 | Pages 98 - 106
27 Jan 2022
Gelfer Y Leo DG Russell A Bridgens A Perry DC Eastwood DM

Aims. To identify the minimum set of outcomes that should be collected in clinical practice and reported in research related to the care of children with idiopathic congenital talipes equinovarus (CTEV). Methods. A list of outcome measurement tools (OMTs) was obtained from the literature through a systematic review. Further outcomes were collected from patients and families through a questionnaire and interview process. The combined list, as well as the appropriate follow-up timepoint, was rated for importance in a two-round Delphi process that included an international group of orthopaedic surgeons, physiotherapists, nurse practitioners, patients, and families. Outcomes that reached no consensus during the Delphi process were further discussed and scored for inclusion/exclusion in a final consensus meeting involving international stakeholder representatives of practitioners, families, and patient charities. Results. In total, 39 OMTs were included from the systematic review. Two additional OMTs were identified from the interviews and questionnaires, and four were added after round one Delphi. Overall, 22 OMTs reached ‘consensus in’ during the Delphi and two reached ‘consensus out’; 21 OMTs reached ‘no consensus’ and were included in the final consensus meeting. In all, 21 participants attended the consensus meeting, including a wide diversity of clubfoot practitioners, parent/patient representative, and an independent chair. A total of 21 outcomes were discussed and voted upon; six were voted ‘in’ and 15 were voted ‘out’. The final COS document includes nine OMTs and two existing outcome scores with a total of 31 outcome parameters to be collected after a minimum follow-up of five years. It incorporates static and dynamic clinical findings, patient-reported outcome measures, and a definition of CTEV relapse. Conclusion. We have defined a minimum set of outcomes to draw comparisons between centres and studies in the treatment of CTEV. With the use of these outcomes, we hope to allow more meaningful research and a better clinical management of CTEV. Cite this article: Bone Jt Open 2022;3(1):98–106


Bone & Joint Open
Vol. 5, Issue 1 | Pages 53 - 59
19 Jan 2024
Bialaszewski R Gaddis J Laboret B Bergman E Mulligan EP LaCross J Stewart A Wells J

Aims. Social media is a popular resource for patients seeking medical information and sharing experiences. periacetabular osteotomy (PAO) is the gold-standard treatment for symptomatic acetabular dysplasia with good long-term outcomes. However, little is known regarding the perceived outcomes of PAO on social media. The aims of this study were to describe the perceived outcomes following PAO using three social media platforms: Facebook, Instagram, and X (formerly known as Twitter). Methods. Facebook, Instagram, and X posts were retrospectively collected from 1 February 2023. Facebook posts were collected from the two most populated interest groups: “periacetabular osteotomy” and “PAO Australia.” Instagram and X posts were queried using the most popular hashtags: #PAOwarrior, #periacetabularosteotomy, #periacetabularosteotomyrecovery, #PAOsurgery, and #PAOrecovery. Posts were assessed for demographic data (sex, race, location), perspective (patient, physician, professional organization, industry), timing (preoperative vs postoperative), and perceived outcome (positive, negative, neutral). Results. A total of 1,054 Facebook posts, 1,003 Instagram posts, and 502 X posts were consecutively assessed from 887 unique authors. The majority (63.3%) of these posts were from patients in the postoperative period, with a median of 84 days postoperatively (interquartile range 20 to 275). The longest follow-up timeframe postoperatively was 20 years. Regarding perceived outcomes, 52.8% expressed satisfaction, 39.7% held neutral opinions, and 7.5% were dissatisfied. Most dissatisfied patients (50.9%) reported pain (chronic or uncontrolled acute) as an attributing factor. Conclusion. Most PAO-perceived surgical outcomes on social media had a positive tone. Findings also indicate that a small percentage of patients reported negative perceived outcomes. However, dissatisfaction with PAO primarily stemmed from postoperative pain. Social media posts from other sources (physicians, hospitals, professional organizations, etc.) trend towards neutrality. Healthcare providers must consider the social media narratives of patients following PAO, as they may reveal additional outcome expectations and help improve patient-centred care, create informed decision-making, and optimize treatment outcomes. Cite this article: Bone Jt Open 2024;5(1):53–59


Bone & Joint Open
Vol. 2, Issue 2 | Pages 79 - 85
15 Feb 2021
Downie S Stillie A Moran M Sudlow C Simpson AHRW

Aims. Surgery is often indicated in patients with metastatic bone disease (MBD) to improve pain and maximize function. Few studies are available which report on clinically meaningful outcomes such as quality of life, function, and pain relief after surgery for MBD. This is the published protocol for the Bone Metastasis Audit — Patient Reported Outcomes (BoMA-PRO) multicentre MBD study. The primary objective is to ascertain patient-reported quality of life at three to 24 months post-surgery for MBD. Methods. This will be a prospective, longitudinal study across six UK orthopaedic centres powered to identify the influence of ten patient variables on quality of life at three months after surgery for MBD. Adult patients managed for bone metastases will be screened by their treating consultant and posted out participant materials. If they opt in to participate, they will receive questionnaire packs at regular intervals from three to 24 months post-surgery and their electronic records will be screened until death or five years from recruitment. The primary outcome is quality of life as measured by the European Organisation for Research and the Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ) C30 questionnaire. The protocol has been approved by the Newcastle & North Tyneside 2 Research Ethics Committee (REC ref 19/NE/0303) and the study is funded by the Royal College of Physicians and Surgeons of Glasgow (RCPSG) and the Association for Cancer Surgery (BASO-ACS). Discussion. This will be the first powered study internationally to investigate patient-reported outcomes after orthopaedic treatment for bone metastases. We will assess quality of life, function, and pain relief at three to 24 months post-surgery and identify which patient variables are significantly associated with a good outcome after MBD treatment. Cite this article: Bone Jt Open 2021;2(2):79–85


Bone & Joint Open
Vol. 3, Issue 9 | Pages 692 - 700
2 Sep 2022
Clement ND Smith KM Baron YJ McColm H Deehan DJ Holland J

Aims. The primary aim of our study was to assess the influence of age on hip-specific outcome following total hip arthroplasty (THA). Secondary aims were to assess health-related quality of life (HRQoL) and level of activity according to age. Methods. A prospective cohort study was conducted. All patients were fitted with an Exeter stem with a 32 mm head on highly cross-linked polyethylene (X3RimFit) cemented acetabulum. Patients were recruited into three age groups: < 65 years, 65 to 74 years, and ≥ 75 years, and assessed preoperatively and at three, 12, 24, and 60 months postoperatively. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Harris Hip Score (HHS), and Hip disability and Osteoarthritis Outcome Score (HOOS), were used to assess hip-specific outcome. EuroQol five-dimension five-level questionnaire (EQ-5D-5L) and 36-Item Short Form Survey (SF-36) scores were used to assess HRQoL. The Lower Extremity Activity Scale (LEAS) and Timed Up and Go (TUG) were used to assess level of activity. Results. There were no significant (p > 0.05) differences in the WOMAC scores, HSS, HOOS, or EQ-5D-5L at any postoperative timepoint between the age groups. Patients aged ≥ 75 years had significantly lower physical function (p ≤ 0.010) and physical role (p ≤ 0.047) SF-36 scores at 12, 24, and 60 months, but were equal to that expect of an age-matched population. No differences according to age were observed for the other six domains of the SF-36 (p > 0.060). The ≥ 75 years group had a lower LEAS (p < 0.001) and longer TUG test times (p ≤ 0.032) compared to the < 65 years group, but older age groups had significant (p < 0.001) improvement relative to their preoperative baseline measures. Conclusion. Age did not influence postoperative hip-specific outcome or HRQoL (according to the EQ-5D) following THA. Despite a significant improvement, older patients had lower postoperative activity levels compared to younger patients, but this may be reflective of the overall physical effect of ageing. Cite this article: Bone Jt Open 2022;3(9):692–700


Bone & Joint Open
Vol. 4, Issue 2 | Pages 87 - 95
10 Feb 2023
Deshmukh SR Kirkham JJ Karantana A

Aims. The aim of this study was to develop a core outcome set of what to measure in all future clinical research on hand fractures and joint injuries in adults. Methods. Phase 1 consisted of steps to identify potential outcome domains through systematic review of published studies, and exploration of the patient perspective through qualitative research, consisting of 25 semi-structured interviews and five focus groups. Phase 2 involved key stakeholder groups (patients, hand surgeons, and hand therapists) prioritizing the outcome domains via a three-round international Delphi survey, with a final consensus meeting to agree the final core outcome set. Results. The systematic review of 160 studies identified 74 outcome domains based on the World Health Organization International Classification of Functioning, Disability, and Health. Overall, 35 domains were generated through thematic analysis of the patient interviews and focus groups. The domains from these elements were synthesised to develop 37 outcome domains as the basis of the Delphi survey, with a further four generated from participant suggestions in Round 1. The Delphi survey identified 20 outcome domains as ‘very important’ for the core outcome set. At the consensus meeting, 27 participants from key stakeholder groups selected seven outcomes for the core outcome set: pain/discomfort with activity, pain/discomfort with rest, fine hand use/dexterity, self-hygiene/personal care, return to usual work/job, range of motion, and patient satisfaction with outcome/result. Conclusion. This set of core outcome domains is recommended as a minimum to be reported in all clinical research on hand fractures and joint injuries in adults. While this establishes what to measure, future work will focus on determining how best to measure these outcomes. By adopting this patient-centred core outcome set, consistency and comparability of studies will be improved, aiding meta-analysis and strengthening the evidence base for management of these common and impactful injuries. Cite this article: Bone Jt Open 2023;4(2):87–95


Bone & Joint Open
Vol. 4, Issue 5 | Pages 338 - 356
10 May 2023
Belt M Robben B Smolders JMH Schreurs BW Hannink G Smulders K

Aims. To map literature on prognostic factors related to outcomes of revision total knee arthroplasty (rTKA), to identify extensively studied factors and to guide future research into what domains need further exploration. Methods. We performed a systematic literature search in MEDLINE, Embase, and Web of Science. The search string included multiple synonyms of the following keywords: "revision TKA", "outcome" and "prognostic factor". We searched for studies assessing the association between at least one prognostic factor and at least one outcome measure after rTKA surgery. Data on sample size, study design, prognostic factors, outcomes, and the direction of the association was extracted and included in an evidence map. Results. After screening of 5,660 articles, we included 166 studies reporting prognostic factors for outcomes after rTKA, with a median sample size of 319 patients (30 to 303,867). Overall, 50% of the studies reported prospectively collected data, and 61% of the studies were performed in a single centre. In some studies, multiple associations were reported; 180 different prognostic factors were reported in these studies. The three most frequently studied prognostic factors were reason for revision (213 times), sex (125 times), and BMI (117 times). Studies focusing on functional scores and patient-reported outcome measures as prognostic factor for the outcome after surgery were limited (n = 42). The studies reported 154 different outcomes. The most commonly reported outcomes after rTKA were: re-revision (155 times), readmission (88 times), and reinfection (85 times). Only five studies included costs as outcome. Conclusion. Outcomes and prognostic factors that are routinely registered as part of clinical practice (e.g. BMI, sex, complications) or in (inter)national registries are studied frequently. Studies on prognostic factors, such as functional and sociodemographic status, and outcomes as healthcare costs, cognitive and mental function, and psychosocial impact are scarce, while they have been shown to be important for patients with osteoarthritis. Cite this article: Bone Jt Open 2023;4(5):338–356


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. Results. A total of 3,303 records were screened, of which 99 studies were included. Most studies were case series (77/99; 78%) and assessed one method of reconstruction (68/99; 69%). A total of 511 outcomes were reported, which were grouped into 58 distinct outcomes. Overall, 143/511 of all outcomes (28%) were provided with a clear, in-text definition, and 231 outcomes (45%) had details reported of how and when they were measured. The most commonly reported outcome was ‘recurrence of osteomyelitis’ (62; 12%). The single-most patient-reported outcome measure was ‘pain’. Conclusion. This study has highlighted significant inconsistencies in the defining, reporting, and measuring of outcomes across studies investigating surgical management for chronic osteomyelitis of the lower limb in adults. Future studies should clearly report complete details of how outcomes are defined and measured, including timing. The development of a standardized core outcome set would be of significant benefit in order to allow evidence synthesis and comparison across studies. Cite this article: Bone Jt Open 2023;4(3):146–157


The Bone & Joint Journal
Vol. 105-B, Issue 12 | Pages 1271 - 1278
1 Dec 2023
Rehman Y Korsvold AM Lerdal A Aamodt A

Aims. This study compared patient-reported outcomes of three total knee arthroplasty (TKA) designs from one manufacturer: one cruciate-retaining (CR) design, and two cruciate-sacrificing designs, anterior-stabilized (AS) and posterior-stabilized (PS). Methods. Patients scheduled for primary TKA were included in a single-centre, prospective, three-armed, blinded randomized trial (n = 216; 72 per group). After intraoperative confirmation of posterior cruciate ligament (PCL) integrity, patients were randomly allocated to receive a CR, AS, or PS design from the same TKA system. Insertion of an AS or PS design required PCL resection. The primary outcome was the mean score of all five subscales of the Knee injury and Osteoarthritis Outcome Score (KOOS) at two-year follow-up. Secondary outcomes included all KOOS subscales, Oxford Knee Score, EuroQol five-dimension health questionnaire, EuroQol visual analogue scale, range of motion (ROM), and willingness to undergo the operation again. Patient satisfaction was also assessed. Results. Patients reported similar levels of pain, function, satisfaction, and general health regardless of the prosthetic design they received. Mean maximal flexion (129° (95% confidence interval (CI) 127° to 131°) was greater in the PS group than in the CR (120° (95% CI 121° to 124°)) and AS groups (122° (95% CI 120° to 124°)). Conclusion. Despite differences in design and constraint, CR, AS, and PS designs from a single TKA system resulted in no differences in patient-reported outcomes at two-year follow-up. PS patients had statistically better ROM, but the clinical significance of this finding is unclear. Cite this article: Bone Joint J 2023;105-B(12):1271–1278


Bone & Joint Open
Vol. 5, Issue 5 | Pages 401 - 410
20 May 2024
Bayoumi T Burger JA van der List JP Sierevelt IN Spekenbrink-Spooren A Pearle AD Kerkhoffs GMMJ Zuiderbaan HA

Aims. The primary objective of this registry-based study was to compare patient-reported outcomes of cementless and cemented medial unicompartmental knee arthroplasty (UKA) during the first postoperative year. The secondary objective was to assess one- and three-year implant survival of both fixation techniques. Methods. We analyzed 10,862 cementless and 7,917 cemented UKA cases enrolled in the Dutch Arthroplasty Registry, operated between 2017 and 2021. Pre- to postoperative change in outcomes at six and 12 months’ follow-up were compared using mixed model analyses. Kaplan-Meier and Cox regression models were applied to quantify differences in implant survival. Adjustments were made for patient-specific variables and annual hospital volume. Results. Change from baseline in the Oxford Knee Score (OKS) and activity-related pain was comparable between groups. Adjustment for covariates demonstrated a minimally greater decrease in rest-related pain in the cemented group (β = -0.09 (95% confidence interval (CI) -0.16 to -0.01)). Cementless fixation was associated with a higher probability of achieving an excellent OKS outcome (> 41 points) (adjusted odds ratio 1.2 (95% CI 1.1 to 1.3)). The likelihood of one-year implant survival was greater for cemented implants (adjusted hazard ratio (HR) 1.35 (95% CI 1.01 to 1.71)), with higher revision rates for periprosthetic fractures of cementless implants. During two to three years’ follow-up, the likelihood of implant survival was non-significantly greater for cementless UKA (adjusted HR 0.64 (95% CI 0.40 to 1.04)), primarily due to increased revision rates for tibial loosening of cemented implants. Conclusion. Cementless and cemented medial UKA led to comparable improvement in physical function and pain reduction during the initial postoperative year, albeit with a greater likelihood of achieving excellent OKS outcomes after cementless UKA. Anticipated differences in early physical function and pain should not be a decisive factor in the choice of fixation technique. However, surgeons should consider the differences in short- and long-term implant survival when deciding which implant to use. Cite this article: Bone Jt Open 2024;5(5):401–410


Bone & Joint Open
Vol. 3, Issue 10 | Pages 832 - 840
24 Oct 2022
Pearson NA Tutton E Joeris A Gwilym SE Grant R Keene DJ Haywood KL

Aims. To describe outcome reporting variation and trends in non-pharmacological randomized clinical trials (RCTs) of distal tibia and/or ankle fractures. Methods. Five electronic databases and three clinical trial registries were searched (January 2000 to February 2022). Trials including patients with distal tibia and/or ankle fractures without concomitant injuries were included. One reviewer conducted all searches, screened titles and abstracts, assessed eligibility, and completed data extraction; a random 10% subset were independently assessed and extracted by a second reviewer at each stage. All extracted outcomes were mapped to a modified version of the International Classification of Functioning, Disability and Health framework. The quality of outcome reporting (reproducibility) was assessed. Results. Overall, 105 trials (n = 16 to 669 participants) from 27 countries were included. Trials compared surgical interventions (n = 62), post-surgical management options (n = 17), rehabilitative interventions (n = 14), surgical versus non-surgical interventions (n = 6), and pre-surgical management strategies (n = 5). In total, 888 outcome assessments were reported across seven domains: 263 assessed body structure or function (85.7% of trials), 136 activities (68.6% of trials), 34 participation (23.8% of trials), 159 health-related quality of life (61.9% of trials), 247 processes of care (80% of trials), 21 patient experiences (15.2% of trials), and 28 economic impact (8.6% of trials). From these, 337 discrete outcomes were described. Outcome reporting was inconsistent across trials. The quality of reporting varied widely (reproducibility ranged 4.8% patient experience to 100% complications). Conclusion. Substantial heterogeneity in outcome selection, assessment methods, and reporting quality were described. Despite the large number of outcomes, few are reported across multiple trials. Most outcomes are clinically focused, with little attention to the long-term consequences important to patients. Poor reporting quality reduces confidence in data quality, inhibiting data synthesis by which to inform care decisions. Outcome reporting guidance and standardization, which captures the outcomes that matter to multiple stakeholders, are urgently required. Cite this article: Bone Jt Open 2022;3(10):832–840


The Bone & Joint Journal
Vol. 104-B, Issue 5 | Pages 541 - 548
1 May 2022
Zhang J Ng N Scott CEH Blyth MJG Haddad FS Macpherson GJ Patton JT Clement ND

Aims. This systematic review aims to compare the precision of component positioning, patient-reported outcome measures (PROMs), complications, survivorship, cost-effectiveness, and learning curves of MAKO robotic arm-assisted unicompartmental knee arthroplasty (RAUKA) with manual medial unicompartmental knee arthroplasty (mUKA). Methods. Searches of PubMed, MEDLINE, and Google Scholar were performed in November 2021 according to the Preferred Reporting Items for Systematic Review and Meta-­Analysis statement. Search terms included “robotic”, “unicompartmental”, “knee”, and “arthroplasty”. Published clinical research articles reporting the learning curves and cost-effectiveness of MAKO RAUKA, and those comparing the component precision, functional outcomes, survivorship, or complications with mUKA, were included for analysis. Results. A total of 179 articles were identified from initial screening, of which 14 articles satisfied the inclusion criteria and were included for analysis. The papers analyzed include one on learning curve, five on implant positioning, six on functional outcomes, five on complications, six on survivorship, and three on cost. The learning curve was six cases for operating time and zero for precision. There was consistent evidence of more precise implant positioning with MAKO RAUKA. Meta-analysis demonstrated lower overall complication rates associated with MAKO RAUKA (OR 2.18 (95% confidence interval (CI) 1.06 to 4.49); p = 0.040) but no difference in re-intervention, infection, Knee Society Score (KSS; mean difference 1.64 (95% CI -3.00 to 6.27); p = 0.490), or Western Ontario and McMaster Universities Arthritis Index (WOMAC) score (mean difference -0.58 (95% CI -3.55 to 2.38); p = 0.700). MAKO RAUKA was shown to be a cost-effective procedure, but this was directly related to volume. Conclusion. MAKO RAUKA was associated with improved precision of component positioning but was not associated with improved PROMs using the KSS and WOMAC scores. Future longer-term studies should report functional outcomes, potentially using scores with minimal ceiling effects and survival to assess whether the improved precision of MAKO RAUKA results in better outcomes. Cite this article: Bone Joint J 2022;104-B(5):541–548