Aims

To map the Oxford Knee Score (OKS) and High Activity Arthroplasty Score (HAAS) items to a common scale, and to investigate the psychometric properties of this new scale for the measurement of knee health.

Background & purpose. Measurement inconsistency across clinical trials is tackled by the development of a core outcome measurement set. Four core outcome domains were recommended for clinical trials in patients with non-specific LBP (nsLBP): physical functioning, pain intensity, health-related quality of life (HRQoL), and number of deaths. This study aimed to reach consensus on core instruments to measure the first three domains. Methods & Results. The Steering Committee overseeing this project selected 17 potential core instruments for physical functioning, three for pain intensity, and five for HRQoL. Evidence on their measurement properties in nsLBP was synthesized in three systematic reviews using COSMIN methodology. Researchers, clinicians, and patients (n = 208) were invited in a Delphi survey to seek consensus on which instruments to endorse as core. Consensus was a-priori set at 67% of participants agreeing on endorsing an instrument. Two Delphi rounds were run (response rates = 44% and 41%). Agreement was reached on endorsing the Oswestry Disability Index (ODI 2.1a) for physical functioning, the Numeric Rating Scale (NRS) for pain intensity, but not on other instruments. Several participants demanded to have free of charge core instruments. Taking these results into account, the steering committee formulated the following recommendations: ODI 2.1a or 24-item Roland Morris Disability Questionnaire for physical functioning, NRS for pain intensity, Short-Form 12 or 10-item PROMIS Global Health for HRQoL. Conclusion. A core outcome measurement set is available for clinical trials in patients with nsLBP. High quality clinimetric studies directly comparing recommended and not recommended instruments are required. Conflict of interest: None. Source of funding: EUROSPINE, The Spine Society of Europe

Surgeons need to be able to measure angles and distances in three dimensions in the planning and assessment of knee replacement. Computed tomography (CT) offers the accuracy needed but involves greater radiation exposure to patients than traditional long-leg standing radiographs, which give very little information outside the plane of the image.

There is considerable variation in CT radiation doses between research centres, scanning protocols and individual scanners, and ethics committees are rightly demanding more consistency in this area.

By refining the CT scanning protocol we have reduced the effective radiation dose received by the patient down to the equivalent of one long-leg standing radiograph. Because of this, it will be more acceptable to obtain the three-dimensional data set produced by CT scanning. Surgeons will be able to document the impact of implant position on outcome with greater precision.

Introduction: Multiple scoring systems are available to evaluate arthritic hip pain and to assess outcome after arthroplasty. These scores focus on evaluating hip pain and function in elderly patients with degenerative joint disease. They are not specific for sports-related or mechanical hip symptoms in young people, or sensitive to change after new treatments such as arthroscopic hip surgery.

Methods: We systematically reviewed the literature since 1980, searching for systems used to measure severity of symptoms and outcome of treatment in these patients. We collected reports of performance of these systems. We then used the best of them to collect symptom scores from 200 patients, and measured the agreement of systems. We performed an item reduction process to identify the question items most associated with overall scores.

Results: Systematic review yielded 4 scoring systems which have been used to evaluate sports-related or mechanical hip symptoms: the Non-arthritic Hip Score (NHS), Hip Outcome Score (HOS), Hip disability and Osteoarthritis Outcome Score (HOOS)and a modified Harris Hip Score (mHHS). All scores are self administered and symptom related, requiring no physical examination. All but the mHHS have some evidence of reliability and validity. There is a great deal of overlap among the variables selected by the authors and agreement between the various scoring systems is surprisingly good. Most of the variability of all of the systems could be captured with ten simple questions.

Conclusion: We have developed a simple set of ten questions which capture outcome information as well as existing more complex systems. This will be useful is assessing outcome after new treatments such as hip arthroscopy in young active people.

Patient-centred medicine is an approach to medical care that emphasises the patient experience. Treatment outcome measures reflect this experience, and outcomes are measured by obtaining patient feedback. Central to this type of care is the patient-physician relationship. Communication, physician empathy, and shared decision making are key components of this relationship. Patient-centred care is correlated with better patient outcomes across medical specialties and higher patient perceived quality of care. Payors are now using patient-centred quality measures in their physician reimbursement schedules.

Introduction: Randomised Controlled Trials (RCTs) of interventions to reduce the incidence of falls have used a variety of methods to define and measure outcomes. A standardised approach to defining and measuring outcomes, and a shared taxonomy of interventions is a prerequisite to interpret and disseminate the findings of studies.

Method: We agreed to focus on five areas: falls, injuries, psychological consequences, physical activity and quality of life. A systematic literature review has been performed to identify outcome definitions currently used in RCTs and is focusing on the quality of outcome measures in terms of reliability, validity and acceptability. A consensus building process is being performed using a modified nominal group technique to define a core set of outcome definitions and measures, which can then be piloted in a number of sites across Europe. Where consensus cannot be achieved, suggestions are made for future research to develop and/or appraise new methods of measurement and these will feed into future revisions of the recommendations. The taxonomy of interventions is being developed in parallel with this process.

Results: The presentation will demonstrate how varying methods of defining falls can lead to a different interpretation of trial results and suggest a range of definitions than might be included in future trials. We consider the number of falls, number of fallers, time to first fall, and fractures per fall ratios as examples.

Conclusions: An agreed and standardised set of outcome definitions and measures is important to improve the robustness of data from intervention studies, will enable comparison across studies, good quality measurement in multi-centre trials, and facilitate meta-analysis of trial results. A taxonomy of interventions facilitates comparisons between studies, helps to determine the most effective components or sub-components of interventions, and aids the decision making process of policy makers and health insurance plans.

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

Aims. Children with spinal dysraphism can develop various musculoskeletal deformities, necessitating a range of orthopaedic interventions, causing significant morbidity, and making considerable demands on resources. This systematic review aimed to identify what outcome measures have been reported in the literature for children with spinal dysraphism who undergo orthopaedic interventions involving the lower limbs. Methods. A PROSPERO-registered systematic literature review was performed following PRISMA guidelines. All relevant studies published until January 2023 were identified. Individual outcomes and outcome measurement tools were extracted verbatim. The measurement tools were assessed for reliability and validity, and all outcomes were grouped according to the Outcome Measures Recommended for use in Randomized Clinical Trials (OMERACT) filters. Results. From 91 eligible studies, 27 individual outcomes were identified, including those related to clinical assessment (n = 12), mobility (n = 4), adverse events (n = 6), investigations (n = 4), and miscellaneous (n = 1). Ten outcome measurement tools were identified, of which Hoffer’s Functional Ambulation Scale was the most commonly used. Several studies used unvalidated measurement tools originally developed for other conditions, and 26 studies developed new measurement tools. On the OMERACT filter, most outcomes reported pathophysiology and/or the impact on life. There were only six patient- or parent-reported outcomes, and none assessed the quality of life. Conclusion. The outcomes that were reported were heterogenous, lack validation and failed to incorporate patient or family perceptions. Until outcomes can be reported unequivocally, research in this area will remain limited. Our findings should guide the development of a core outcome set, which will allow consistency in the reporting of outcomes for this condition. Cite this article: Bone Joint J 2024;106-B(3):277–285

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

Aims. Lower limb reconstruction (LLR) has a profound impact on patients, affecting multiple areas of their lives. Many patient-reported outcome measures (PROMs) are employed to assess these impacts; however, there are concerns that they do not adequately capture all outcomes important to patients, and may lack content validity in this context. This review explored whether PROMs used with adults requiring, undergoing, or after undergoing LLR exhibited content validity and adequately captured outcomes considered relevant and important to patients. Methods. A total of 37 PROMs were identified. Systematic searches were performed to retrieve content validity studies in the adult LLR population, and hand-searches used to find PROM development studies. Content validity assessments for each measure were performed following Consensus-based Standards for the selection of health measurement Instruments (COSMIN) guidelines. A mapping exercise compared all PROMs to a conceptual framework previously developed by the study team (‘the PROLLIT framework’) to explore whether each PROM covered important and relevant concepts. Results. The systematic searches found 13 studies, while hand searches found 50 PROM development studies, and copies of all 37 measures. Although several studies discussed content validity, none were found which formally assessed this measurement property in the adult LLR population. Development of many PROMs was rated as inadequate, no PROM had sufficient content validity in the study population, and none covered all areas of the PROLLIT framework. The LIMB-Q was the most promising and comprehensive measure assessed, although further validation in a wider sample of LLR patients was recommended. Conclusion. Current PROMs used in adults requiring, undergoing, or after undergoing LLR lack content validity and do not assess all important and relevant outcomes. There is an urgent need for improved outcome measurement in this population. This can be achieved through development of a new PROM, or through validation of existing measures in representative samples. Cite this article: Bone Jt Open 2024;5(12):1049–1066

Aims. The aim of this study was to compare the pattern of initial fixation and changes in periprosthetic bone mineral density (BMD) between patients who underwent total hip arthroplasty (THA) using a traditional fully hydroxyapatite (HA)-coated stem (T-HA group) and those with a newly introduced fully HA-coated stem (N-HA group). Methods. The study included 36 patients with T-HA stems and 30 with N-HA stems. Dual-energy X-ray absorptiometry was used to measure the change in periprosthetic BMD, one and two years postoperatively. The 3D contact between the stem and femoral cortical bone was evaluated using a density-mapping system, and clinical assessment, including patient-reported outcome measurements, was recorded. Results. There were significantly larger contact areas in Gruen zones 3, 5, and 6 in the N-HA group than in the T-HA group. At two years postoperatively, there was a significant decrease in BMD around the proximal-medial femur (zone 6) in the N-HA group and a significant increase in the T-HA group. BMD changes in both groups correlated with BMI or preoperative lumbar BMD rather than with the extent of contact with the femoral cortical bone. Conclusion. The N-HA-coated stem showed a significantly larger contact area, indicating a distal fixation pattern, compared with the traditional fully HA-coated stem. The T-HA-coated stem showed better preservation of periprosthetic BMD, two years postoperatively. Surgeons should consider these patterns of fixation and differences in BMD when selecting fully HA-coated stems for THA, to improve the long-term outcomes. Cite this article: Bone Joint J 2024;106-B(6):548–554

Abstract. Background. The Forgotten Joint Score (FJS) is a 12-item patient reported outcome measurement instrument. It was developed with classical test theory, without testing assumptions such as unidimensionality (all items reflect one underlying factor), appropriate weighting of each item, no differential item function (DIF, different groups answer the same way), and monotonicity (people with higher function have higher score). We applied item response theory (IRT) to improve the validity of FJS to contemporary standards to optimise it for ongoing use. Research Questions. Does the FJS reflect one latent trait? Can an IRT model be fitted to the FJS to provide interval-scaled measurement?. Methodology. Participants undergoing primary total knee replacement provided pre-operative and post-operative (6-months) responses for FJS. An exploratory factor analysis (EFA), confirmatory factor analysis (CFA) and Mokken analysis were conducted. The data were fitted to a graded response model (GRM). Results. 1288 response patterns were analysed. EFA showed a one factor model (all 12 items load to one underlying trait). CFA demonstrated excellent model fit (X2 <0.001, Tucker Lewis Index=0.96, Comparative Fit Index=0.96). Items did not have equal weighting. The FJS demonstrated good monotonicity with no differential item functioning by sex, age, or body mass index. Conclusions. The FJS meets key validity assumptions supporting its use in clinical practice and research. The IRT-adapted FJS provides continuous measurements with greater granularity including individual measurement error. This adapted score has advantages over traditional FJS scoring, being interval scaled (using GRM) and can be retrospectively applied to existing response sets

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

Aims. Hyaline cartilage has a low capacity for regeneration. Untreated osteochondral lesions of the femoral head can lead to progressive and symptomatic osteoarthritis of the hip. The purpose of this study is to analyze the clinical and radiological long-term outcome of patients treated with osteochondral autograft transfer. To our knowledge, this study represents a series of osteochondral autograft transfer of the hip with the longest follow-up. Methods. We retrospectively evaluated 11 hips in 11 patients who underwent osteochondral autograft transfer in our institution between 1996 and 2012. The mean age at the time of surgery was 28.6 years (8 to 45). Outcome measurement included standardized scores and conventional radiographs. Kaplan-Meier survival curve was used to determine the failure of the procedures, with conversion to total hip arthroplasty (THA) defined as the endpoint. Results. The mean follow-up of patients treated with osteochondral autograft transfer was 18.5 years (9.3 to 24.7). Six patients developed osteoarthritis and had a THA at a mean of 10.3 years (1.1 to 17.3). The cumulative survivorship of the native hips was 91% (95% confidence interval (CI) 74 to 100) at five years, 62% (95% CI 33 to 92) at ten years, and 37% (95% CI 6 to 70) at 20 years. Conclusion. This is the first study analyzing the long-term results of osteochondral autograft transfer of the femoral head. Although most patients underwent conversion to THA in the long term, over half of them survived more than ten years. Osteochondral autograft transfer could be a time-saving procedure for young patients with devastating hip conditions who have virtually no other surgical options. A larger series or a similar matched cohort would be necessary to confirm these results which, in view of the heterogeneity of our series, seems difficult to achieve. Cite this article: Bone Jt Open 2023;4(7):523–531

The direct superior approach (DSA) is a modification of the posterior approach (PA) that preserves the iliotibial band and short external rotators except for the piriformis or conjoined tendon during total hip arthroplasty (THA). The objective of this study was to compare postoperative pain, early functional rehabilitation, functional outcomes, implant positioning, implant migration, and complications in patients undergoing the DSA versus PA for THA. This study included 80 patients with symptomatic hip arthritis undergoing primary THA. Patients were prospectively randomised to receive either the DSA or PA for THA, surgery was undertaken using identical implant designs in both groups, and all patients received a standardized postoperative rehabilitation programme. Predefined study outcomes were recorded by blinded observers at regular intervals for two-years after THA. Radiosteriometric analysis (RSA) was used to assess implant migration. There were no statistical differences between the DSA and PA in postoperative pain scores (p=0.312), opiate analgesia consumption (p=0.067), and time to hospital discharge (p=0.416). At two years follow-up, both groups had comparable Oxford hip scores (p=0.476); Harris hip scores (p=0.293); Hip disability and osteoarthritis outcome scores (p=0.543); University of California at Los Angeles scores (p=0.609); Western Ontario and McMaster Universities Arthritis Index (p=0.833); and European Quality of Life questionnaire with 5 dimensions scores (p=0.418). Radiographic analysis revealed no difference between the two treatment groups for overall accuracy of acetabular cup positioning (p=0.687) and femoral stem alignment (p=0.564). RSA revealed no difference in femoral component migration (p=0.145) between the groups at two years follow-up. There were no differences between patients undergoing the DSA versus PA for THA with respect to postoperative pain scores, functional rehabilitation, patient-reported outcome measurements, accuracy of implant positioning, and implant migration at two years follow-up. Both treatment groups had excellent outcomes that remained comparable at all follow-up intervals

Our understanding of pre-arthritic hip disease has evolved tremendously but challenges remain in categorizing diagnosis, which ultimately impacts choice of treatments and clinical outcomes. This study aims to report patient reported outcome measures (PROMs) comparing four different condition groups within hip preservation surgery by a group of fellowship-trained surgeons. From 2018 to 2021, 380 patients underwent hip preservation surgery at our center and were classified into five condition groups: dysplasia: 82 (21.6%), femoro-acetabular impingement (FAI): 173 (45.4%), isolated labral tear: 103 (27.1%), failed hip preservation: 20 (5.3%) and history of childhood disease/other: 2 (0.5%). International hip outcomes Tool 12 (IHOT-12), numeric pain score and patient-reported outcomes measurement information system (PROMIS) were collected pre-operatively and at 3 months and 1 year post-operatively, with 94% and 82% follow-up rate respectively. Arthroscopy (75.5%) was the most common procedure followed by peri-acetabular osteotomy (PAO) (22.4%) and surgical dislocation (2.1%). Re-operation rate were respectively 18.3% (15), 5.8% (10), 4.9% (5), 30% (6) and 0%. There were 36 re-operations in the cohort, 14 (39%) for unintended consequences of initial surgery, 10 (28%) for mal-correction leading to a repeat operation, 8 (22%) progression of arthritis, and 4 (11%) for incorrect initial diagnosis/intervention. Most common re-operations were hardware removal 31% (7 PAO, 3 surgical hip dislocation and 1 femoral de-rotational osteotomy), arthroscopy 31% (11) and arthroplasty 28% (10). All groups had significant improvements in their IHOT-12 as well as PROMIS physical and numerical pain scales, except those with failed hip preservation. Dysplasia group showed a slower recovery. Overall, this study demonstrated a clear relation between the condition groups, their respective intervention and the significant improvements in PROMs with isolated labral pathology being a valid diagnosis. Establishing tertiary referral centers for hip preservation and longer follow-up is needed to monitor the overall survivorship of these various procedures

Aims. As an alternative to external fixators, intramedullary lengthening nails (ILNs) can be employed for distraction osteogenesis. While previous studies have demonstrated that typical complications of external devices, such as soft-tissue tethering, and pin site infection can be avoided with ILNs, there is a lack of studies that exclusively investigated tibial distraction osteogenesis with motorized ILNs inserted via an antegrade approach. Methods. A total of 58 patients (median age 17 years (interquartile range (IQR) 15 to 21)) treated by unilateral tibial distraction osteogenesis for a median leg length discrepancy of 41 mm (IQR 34 to 53), and nine patients with disproportionate short stature treated by bilateral simultaneous tibial distraction osteogenesis, with magnetically controlled motorized ILNs inserted via an antegrade approach, were retrospectively analyzed. The median follow-up was 37 months (IQR 30 to 51). Outcome measurements were accuracy, precision, reliability, bone healing, complications, and patient-reported outcome assessed by the Limb Deformity-Scoliosis Research Society Score (LD-SRS-30). Results. A median tibial distraction of 44 mm (IQR 31 to 49) was achieved with a mean distraction index of 0.5 mm/day (standard deviation 0.13) and median consolidation index of 41.2 days/cm (IQR 34 to 51). Accuracy, precision, and reliability were 91%, 92%, and 97%, respectively. New temporary range of motion limitations occurred in 51% of segments (34/67). Distraction-related equinus deformity treated by Achilles tendon lengthening was the most common major complication recorded in 16% of segments (11/67). In 95% of patients (55/58) the distraction goal was achieved with 42% unplanned additional interventions per segment (28/67). The median postoperative LD-SRS-30 score was 4.0 (IQR 3.6 to 4.3). Conclusion. Tibial distraction osteogenesis using motorized ILNs inserted via an antegrade approach appears to be a reliable and precise procedure. Temporary joint stiffness of the knee or ankle should be expected in up to every second patient. A high rate and wide range of complications of variable severity should be anticipated. Cite this article: Bone Joint J 2024;106-B(3):293–302

This study evaluates patient reported outcome measurement information system (PROMIS) scores after total hip arthroplasty (THA) and total ankle arthroplasty (TAA) in matched cohorts, while simultaneously evaluating implant survivorship and 90-day hospital utilization. It is hypothesized that while both procedures would yield similar PROMIS score improvements, THA would demonstrate superior mid-term implant survivorship. Primary THA and TAA patients from 2015–2022 with minimum one-year follow-up were retrospectively reviewed. After applying exclusion criteria, 2,092 THAs and 478 TAAs were included for analysis. Demographics, pre- and post-operative patient reported outcome measures (PROMs), revision surgeries, ED visits, and re-admissions were collected. THA and TAA patients were then propensity score matched at 2:1 ratio for age, sex, race, BMI, ASA, and comorbidities, resulting in a final cohort of 844 THAs and 455 TAAs for comparison. There were similar pre-operative PROMIS Pain Interference (PI) scores between THA and TAA, with both showing improvement at six weeks. However, THA patients exhibited lower PI scores at one year (53.0 versus 54.0; p=0.009). Pre-operative PROMIS Physical Function (PF) was worse in THA patients but showed greater improvement compared to TAA patients at both six weeks (p<0.001) and one year (p<0.001). Pre-operative PROMIS depression scores were similar and improved similarly in both groups. Joint-specific PROMs (HOOS for THA and FAAM for TAA) improved in both cohorts. THA demonstrated superior survivorship free of all-cause revision at five years compared to TAA (95% versus 77%; p<0.0001). Patients undergoing THA or TAA experienced significant improvements in their general and joint-specific PROMs post-operatively. However, patients undergoing THA demonstrated higher PROMIS PI and PF scores at one-year when compared to TAA, as well as improved survivorship. Generic PRO instruments enable comparison of medical treatments in different anatomic sites to the patients overall health

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

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