Patient-reported outcomes (PROs) are widely used in the orthopaedic field to assess the impact of conservative and surgical interventions from a patient's perspective. Available instruments cover a range of outcome parameters, such as pain, function, stiffness, quality of life or joint awareness. Choice of instrument for a specific study for clinical practice should include the appraisal of the psychometric characteristics of the measure. The presentation will focus on the assessment of the psychometric characteristics of PRO instruments and provide criteria for evaluating those. The concepts of objectivity, reliability and validity will be explained in the context of PRO instrument and the interpretation of score points derived from PRO instruments will be discussed detailing concepts such as minimal important change/difference, norm data, and thresholds based on external criteria. Finally, international guidelines that define standards for the various procedures on development, validation and translation of PRO instruments will be summarised

Aim. To evaluate the association of BMI and improvement in patient-reported outcomes after TKA. Methods. Knee replacement outcome data for procedures carried out over an eight month period was extracted from a regional arthroplasty register in the UK. Data was available before surgery and 12 months after. We analysed the impact of overweight on post-operative change in the Forgotten Joint Score − 12 (FJS-12) measuring joint awareness and the Oxford Knee Score (OKS) measuring pain and function using five BMI categories (A: <25, B: 25–29.9, C: 30–34.9, D: 35–39.9 and E: >40). Results. We analysed data from 431 TKA patients with a mean age of 70.1 (SD=9.2 years) and 54.5% being female. Frequency of the BMI categories in our sample were as follows: A) 15.8% with a BMI<25, B) 32.8 % with a BMI 25–29.9, C) 27.7% with a BMI 30–34.9, D) 16.5 % with a BMI 35–39.9, and E) 7.1 % with a BMI above 39.9. Data analysis showed a statistically significant association (Z= 12.10, p=0.02) of BMI with post-operative improvement in the FJS-12 from pre-surgery to 12 months: A) + 37.9 points (Cohen”s d= 1.67); B) + 40.3 points (Cohen”s d= 1.67); C) + 34.0 points (Cohen”s d= 1.54) D) + 29.7 points (Cohen”s d= 1.29) and E) + 23.5 points (Cohen”s d= 1.24). Post-operative change in OKS did not show a statistically significant association with the BMI categories (Z=1.24, p=0.872). Conclusions. Our study shows that obesity has an impact on improvement after TKA in terms of joint awareness, with overweight patients being at higher risk of less benefit from surgery. Whereas the FJS-12 showed a substantial difference in the recovery process, the postoperative improvement measured with the OKS was comparable for patients in the different BMI categories. This highlights that outcome scores may differ in their ability to capture the impact of BMI on postoperative recovery

Patient reported outcomes have become validated objective measures of success in research studies. They take time and effort to develop and administer. However, to remain relevant and universal PROMS should be gathered routinely and used to manage evidence-based change in healthcare systems. To ensure that they are adopted individual clinician involvement is key however a framework for comparison and relevance promotes engagement. Several examples will be presented of system change using PROMS and PREMS as well as using routine data to defend patient selection. How and what we present depends on whom we are expecting to influence.

Abstract

Increasingly more emphasis is being placed on Patient Reported Outcome Measures (PROMs). There are many used and reported in clinical studies, but there are no universally accepted or preferred measures. It is important for a researcher with a non-clinical background to understand how these assessments are performed, the type of information provided by each of the measures, and which diseases states are best reported by each measure.

Background

PROMS and PREMS are a fundamental and essential part of the NHS. Chilectomy and fusion procedures for hallux rigidus produce varied outcomes due to their subjective nature. PROMS2.0, a semi-automated web-based system, which allows collection and analysis of outcome data, to compare what PROMS/PREMS for chilectomy/fusion for hallux rigidus are at UHSM including variance across osteoarthritis grades.

Background

This article reviews four commonly used approaches to assess patient responsiveness to a treatment or therapy [Return To Normal (RTN), Minimal Important Difference (MID), Minimal Clinically Important Difference (MCID), OMERACT-OARSI (OO)], and demonstrates how each of the methods can be formulated in a multi-level modelling (MLM) framework.

Introduction

We used patient reported outcome measures (PROMS) to evaluate qualitative and societal outcomes of trauma.

Background

Patient reported outcomes/experience measures have been a fundamental part of the NHS since 2009. Osteotomy procedures for hallux valgus produce varied outcomes due to their subjective nature. We used PROMS2.0, a semi-automated web-based system, which allows collection and analysis of outcome data, to assess what the patient reported outcome/experience measures for scarf+/− akin osteotomy for hallux valgus are at UHSM.

Robotic assistance in knee arthroplasty has become increasingly popular due to improved accuracy of prosthetic implantation. However, literature on the mid-term outcomes is limited especially that of hand-held robotic-assisted devices. We present one of the longest follow-up series to date using this novel technology and discuss the learning curve for introducing robotic technology into our practice. The purpose of this single-surgeon study is to evaluate the survival, patient-reported outcomes and learning curve for handheld boundary-controlled robotic-assisted unicompartmental knee arthroplasties (HBRUKAs) at our hospital. This retrospective study evaluates 100 cases (94 Medial, 6 Lateral) performed by a single surgeon between October 2012 and July 2018. 52% were males, mean age was 64.5y (range 47.3y-85.2y) and mean BMI was 31.3 (range 21.8–43). Both inlay (40%) and onlay (60%) designs were implanted. Patients were followed up routinely at 1 and 5 years with Oxford Knee Scores (OKS) recorded. The learning curve was determined by tourniquet times. At a mean follow-up of 4.3 years (range 1.6y–7.3y), survivorship was 97%. There were three revisions: One case of aseptic loosening (1.5y), one case of deep-infection (3.8y) and one case of contralateral compartment osteoarthritis progression (5y). Mean 5-year OKS was 39.8. A 14.3% reduction in mean tourniquet times between the first 25 cases (105.5minutes) and subsequent cases (90.4minutes) was seen. This single-surgeon study showed good survivorship and patient-reported outcomes for HBRUKAs at our hospital. A learning curve of approximately 25 cases was shown, with significant decreases in tourniquet times with respect to increased surgeon experience

This study aims to compare the outcomes of Volar locking plating (VLP) versus percutaneous Kirschner wires (K-wire) fixation for surgical management of distal radius fractures. We systematically searched multiple databases, including MEDLINE for randomized controlled trials (RCTs) comparing outcomes of VLP fixation and K-wire for treatment of distal radius fracture in adults. The methodological quality of each study was assessed by the Cochrane Risk of Bias tool. Patient-reported outcomes, functional outcomes, and complications at 1 year follow up were evaluated. Meta-analysis was performed using random-effects models and results presented as risk ratios (RRs) or mean differences (MDs) with 95% confidence interval (CI). 13 RCTs with 1336 participants met the inclusion criteria. Disabilities of the Arm, Shoulder and Hand (DASH) scores were significantly better for VLP fixation (MD= 2.15; 95% CI, 0.56-3.74; P = 0.01; I2=23%). No significant difference between the two procedures for grip strength measured in kilograms (MD= −3.84; 95% CI,-8.42-0.74; P = 0.10; I2=52%) and Patient-Rated Wrist Evaluation (PRWE) scores (MD= −0.06; 95% CI,-0.87-0.75; P = 0.89; I2=0%). K-wire treatment yielded significantly improved extension (MD= −4.30; P=0.04) but with no differences in flexion, pronation, supination, and radial deviation (P >0.05). The risk of complications and rate of reoperation were similar for the two procedures (P >0.05). This meta-analysis suggests that VLP fixation improves DASH score at 12 months follow up, however, the difference is small and unlikely to be clinically important. Existing literature does not provide sufficient evidence to demonstrate the superiority of either VLP or K-wire treatment in terms of patient-reported outcomes, functional outcomes, and complications

Unicompartmental knee arthroplasty (UKA) has a higher risk of revision than total knee arthroplasty, particularly for low volume surgeons. The recent introduction of robotic-arm assisted systems has allowed for increased accuracy, however new systems typically have learning curves. The objective of this study was to determine the learning curve of a robotic-arm assisted system for UKA. Methods A total of 152 consecutive robotic-arm assisted primary medial UKA were performed by five surgeons between 2017 and 2021. Operative times, implant positioning, reoperations and patient-reported outcome measures (PROMS; Oxford Knee Score, EuroQol-5D, and Forgotten Joint Score) were recorded. There was a learning curve of 11 cases with the system that was associated with increased operative time (13 minutes, p<0.01) and improved insert sizing over time (p=0.03). There was no difference in implant survival (98.2%) between learning and proficiency phases (p = 0.15), and no difference in survivorship between ‘high’ and ‘low’ usage surgeons (p = 0.23) at 36 months. There were no differences in PROMS related to the learning curve. This suggested that the learning curve did not lead to early adverse effects in this patient cohort. The introduction of a robotic-arm assisted UKA system led to learning curves for operative time and implant sizing, but there was no effect on patient outcomes at early follow- up. The short learning curve was independent of UKA usage and indicated that robotic-arm assisted UKA may be particularly useful for low-usage surgeons

Unicompartmental knee arthroplasty (UKA) and high tibial osteotomy (HTO) are well-established operative interventions in the treatment of knee osteoarthritis (KOA). However, which of these interventions is more beneficial, to patients with KOA, is not known and remains a topic of much debate. Aims: (i) To determine whether UKA or HTO is more beneficial in the treatment of isolated medial compartment KOA, via an assessment of patient-reported outcome measures (PROMs). (ii) To investigate the relationship between PROMs and radiographic parameters of knee joint orientation/alignment. This longitudinal observational study assessed a total of 42 patients that had undergone UKA (n=23) or HTO (n=19) to treat isolated medial compartment KOA. The PROMs assessed, pre-operatively and 1-year post-operatively, consisted of the: self-administered comorbidity questionnaire; short form-12; oxford knee score; knee injury and osteoarthritis outcome score; and the EQ-5D-5L. The radiographic parameters of knee joint alignment/orientation assessed, pre-operatively and 8-weeks post-operatively, included the: hip-knee-ankle angle; mechanical axis deviation; and the angle of the Mikulicz line. Statistical analysis demonstrated an overall significant (p<0.001), pre-operative to post-operative, improvement in the PROM scores of both groups. There were no significant differences in the post-operative PROM scores of the UKA and HTO group. Correlation analyses revealed that pre-operatively, a more distolaterally angled Mikulicz line was associated with worse knee function (p<0.05) and overall health (p<0.05); a relationship that, until now, has not been investigated nor commented upon within the literature. UKAs and HTOs are both efficacious operations that provide a comparable degree of clinical benefit to patients with isolated medial compartment KOA. To further the scientific/medical community's understanding of the factors that impact upon health-outcomes in KOA, future research should seek to investigate the mechanism underlying the relationship, between Mikulicz line and PROMs, observed within the current study

This study aimed to quantify self-reported outcomes and walking gait biomechanics in patients following primary and revision THA. The specific goals of this study were to investigate: (i) if primary and revision THA patients have comparable preoperative outcomes; and (2) if revision THA patients have worse postoperative outcomes than primary THA patients. Forty-three patients undergoing primary THA for osteoarthritis and 23 patients undergoing revision THA were recruited and followed longitudinally for their first 12 postoperative months. Reasons for revision were loosening (73%), dislocation (9%), and infection (18%). Patients completed the Hip dysfunction and Osteoarthritis Outcome Score (HOOS), and underwent gait analysis preoperatively, and at 3 and 12 months postoperatively. A 10 camera motion analysis system (V5 Vantage, Vicon, UK) recorded marker trajectories (100 Hz) during walking at self- selected speeds. A generic lower-body musculoskeletal model (Gait2392) was scaled using principal component analysis [1] and the inverse kinematics tool in Opensim 3.3 was used to compute joint angles for the lower limbs in the sagittal plane. Independent samples t-test were used to compare patient reported outcomes between the primary and revision groups at each timepoint. Statistical parametric mapping was used to compare gait patterns between the two groups at each timepoint. Preoperatively, patients undergoing primary THA reported significantly worse pain (p<0.001), symptoms (p<0.001), function (p<0.001), and quality of life (p=0.004). No differences were observed at 3 and 12 months postoperatively between patients who had received a primary or revision THA. The only observed difference in gait pattern was that patients with a revision THA had reduced hip extension at 3 months, but no differences were observed preoperatively and 12 months. Despite the suggestions in the literature that revision THA is bound to have worse outcomes compared to primary THA, we found no differences in in patient-reported outcomes and gait patterns at 12 months postoperatively. This suggests that it may be possible, in some circumstances, for patients following revision THA to achieve similar outcomes to their peers undergoing primary THA

Although remnant-preserved ACL reconstruction (ACLR) restores knee joint stability and dampens the problem of acute ACL rupture-induced knee pain, an increasing number of patients still develop post-traumatic osteoarthritis (PTOA) after 10 to 15 years of ACLR. We previously found that remnant-preserved ACLR with concomitant medial and lateral meniscus repair may not prevent cartilage degeneration and weaken muscle strength, while the clinical features of PTOA are not clear. We hypothesized that remnant-preserved ACLR with concomitant medial and lateral meniscus tears is related to early cartilage damage, worse function recovery, patient-reported outcomes (PROs) and delayed duration to return to sports. The aim is to evaluate the remnant-preserved ACLR with complicated meniscal injuries in predicting which patients are at higher risk of osteoarthritic changes, worse function and limited activities after ACLR for 12 months. Human ethical issue was approved by a committee from Xi'an Jiaotong University. 26 young and active patients (24 male, 2 female) with ACL injuries (Sherman type I and II) with concomitant medial and lateral meniscus within 2 months were included from January 2014 to March 2022. The average age of the ACLR+ meniscus repair was 26.77±1.52 (8 right, 5 left) and isolated ACLR control was 31.92±2.61 years old (7 left, 6 right). Remnant-preserved ACLR with a 5- to 6-strand hamstring tendon graft was operated on by the same sports medicine specialists. MRI CUBE-T. 2. scanning with 48 channels was conducted by a professional radiologist. The volume of the ACL graft was created through 3 dimensional MRI model (Mimics 19, Ann Arbor). Anterior Cruciate Ligament OsteoArthritis Score (ACLOAS) was applied to score visible cartilage damage. IKDC 2000 score and VAS were assessed by two blinded researchers. Results were presented as mean± SEM of each group. The cross-sectional area and 3D volume of the ACL graft were greater in the remnant-preserved ACLR+meniscus group compared with isolated ACLR (p=0.01). It showed that ACLR+ meniscus group had early signs of joint damage and delayed meniscus healing regarding ACLOAS compared to control group (p=0.045). MRI CUBE-T. 2. prediction of radiographic cartilage degeneration was not obvious in both groups post remnant-preserved ACLR over 12 months (p>0.05). However, higher VAS scores, lower IKDC scores, and long-last joint swelling were reported in the ACLR+ meniscus repair group at the end of 12 months follow-up. Although remnant-preserved ACLR+ meniscus was able to maintain the restore the knee function, it showed delayed timing (>12 months) to return to play at the pre-injury stage, while no difference between the timing of returning to the normal daily routine of their ACLR knee compared to control (p=0.30). The cost of ACLR+ meniscus (average 10,520.76$) was higher than the control group (6,452.92$, p=0.018). Remnants-preserved ACLR with concomitant injured medial and lateral meniscus repair shows a higher risk of cartilage damage, greater cost, worse functional performance, and longer time for young male patients to return to sports after 12-month follow-up compared to isolated ACLR. Further evidence and long-term follow-up are needed to better understand the association between these results and the risk of development of PTOA in this patient cohort

Abstract. Purpose. Clinical registries are an important aspect of orthopaedic research in assessing the outcomes of surgical intervention and track medical devices. This study aimed to explore the research methodology available to account for patients lost to follow-up (LTFU) specifically in studies related to arthroscopic intervention and whether the rates of patient LTFU are within the acceptable margins for survey studies. Methods. A scoping review, where a literature search for studies from nine arthroscopy registries, was performed on EMBASE, MEDLINE, and the annual reports of each registry. Inclusion criteria included studies with information on patient-reported outcome measures and being based on nine national registries identified. Exclusion criteria included review articles, conference abstracts, studies not based on registry data, and studies from regional, claims-based, or multi-centre registries. Studies were then divided into categories based on method of LTFU analysis used. Results. Thirty-six articles were identified for the final analysis. Categories for LTFU analysis included dropout analyses (n=10), referencing validation studies (n=12), contacting non-responders (n=4), and sensitivity analyses (n=1). Referencing validation studies was the most common method (n=12). Majority (n=35) of the studies exceeded the recommended maximum rates for LTFU. Conclusions. Most arthroscopy studies have rates of LTFU higher than traditionally acceptable. Therefore, any conclusions drawn from these research papers may not be sufficiently valid or free from non-response bias

Introduction and Objective. Platelet-Rich-plasma (PRP) has been used in combination with stem cells, from different sources, with encouraging results both in vitro and in vivo in osteochondral defects management. Adipose-derived Stem Cells (ADSCs) represents an ideal resource for their ease of isolation, abundance, proliferation and differentiation properties into different cell lineages. Furthermore, Stem Cells in the adipose tissue are more numerous than from other sources. Aim of this study was to evaluate the potential of ADSCs in enhancing the effect of arthroscopic mesenchymal stimulation combined with infiltration of PRP. Materials and Methods. The study includes 82 patients. 41 patients were treated with knee arthroscopy, Steadman microfractures technique and intraoperative PRP infiltration, Group A. In the Group B, 41 patients were treated knee arthroscopy, Steadman microfractures and intraoperative infiltration of PRP and ADSCs (Group B). Group A was used as a control group. Inclusion criteria were: Age between 40 and 65 years, Outerbridge grade III-IV chondral lesions, Kellegren-Lawrence Grade I-II. Patient-reported outcome measures (PROMs) evaluated with KOOS, IKDC, VAS, SF-12 were assessed pre-operatively and at 3 weeks, 6 months, 1-year post-operative. 2 patients of Group A and 3 patients of Group B, with indication of Puddu plate removal after high tibial osteotomy (HTO), underwent an arthroscopic second look, after specific informed consent obtained. On this occasion, a bioptic sample was taken from the repair tissue of the chondral lesion previously treated with Steadman microfractures. Results. PROMs showed statistically significant improvement (p <0.05) with comparable results in both groups. The histological examination of the bioptic samples in Group B showed a repair tissue similar to hyaline cartilage, according to the International Cartilage Repair Society (ICRS) Visual Histological Assessment Scale. In Group A, the repair tissue was fibrocartilaginous. Conclusions. According to the PROMs and the histological results, showing repair tissue after Steadman microfractures qualitatively similar to hyaline cartilage, the combination of ADSCs and PRP could represent an excellent support to the arthroscopic treatment of focal chondral lesions and mild to moderate osteoarthritis

The aim of this study was to report the procedure survival and patient-reported outcomes in a consecutive series of patients <50yrs at the time of hip arthroplasty with a metal-on-metal hip resurfacing system who have progressed to a minimum of 10yrs follow-up. Patients presenting for treatment of degenerative conditions of the hip electing to undergo hip resurfacing were included in a clinical registry (N=226 patients; 238 procedures). Procedure survival was confirmed by crosschecking to the Australian Orthopaedic Association National Joint Replacement Registry and comparing to all procedures by other surgeons nationwide. Kaplan-meier survival curves with 95% confidence intervals were constructed, while patient-reported outcome measures were compared with t-tests and postoperative scores assessed with anchor analysis to age and gender-matched normative data. At mean follow up of 12 years, six cases were revised with a cumulative survival rate of 96.8% (95%CI 94.2–99.4) at 15 years. Majority of revisions were early (<3yrs) and occurred in females (N=4). Patient-reported general health, disease state, hip function and activity level maintained large improvements beyond 10 years post-implantation and were equal to or exceeded age and gender-matched normative data. Metal-on-metal hip resurfacing in males and females aged <50 years at time of surgery demonstrated a high rate of cumulative survival beyond 10 years follow up. The results demonstrate excellent outcomes in this age group

Introduction and Objective. Postoperative management regimes vary following open reduction and internal fixation of unstable ankle fractures. There is an evolving understanding that poorer outcomes could be associated with non-weight bearing protocols and immobilisation. Traditional non-weight bearing cast immobilisation may prevent loss of fixation, and this practice continues in many centres. The aim of this systematic review and meta-analysis is to compare the complication rate and functional outcomes of early weight-bearing (EWB) versus late weight-bearing (LWB) following open reduction and internal fixation of ankle fractures. Materials and Methods. We performed a systematic review with a meta-analysis of controlled trials and comparative cohort studies. MEDLINE (via PubMed), Embase and the Cochrane Library electronic databases were searched inclusive of all date up to the search time. We included all studies that investigated the effect of weight-bearing following adults ankle fracture fixation by any means. All ankle fracture types, including isolated lateral malleolus fractures, isolated medial malleolus fractures, bi-malleolar fractures, tri-malleolar fractures and Syndesmosis injuries, were included. All weight-bearing protocols were considered in this review, i.e. immediate weight-bearing (IMW) within 24 hours of surgery, early weight-bearing (EWB) within three weeks of surgery, non-weight-bearing for 4 to 6 weeks from the surgery date (or late weight-bearing LWB). Studies that investigated mobilisation but not weight-bearing, non-English language publications and tibial Plafond fractures were excluded from this systematic review. We assessed the risk of bias using ROB 2 tools for randomised controlled trials and ROBINS-1 for cohort studies. Data extraction was performed using Covidence online software and meta-analysis by using RevMan 5.3. Results. After full-text review, fourteen studies (871 patients with a mean age ranged from 35 to 57 years) were deemed eligible for this systematic review; ten randomised controlled trials and four comparative cohort studies. Most of the included studies were rated as having some concern with regard to the risk of bias. There is no important difference in the infection rate between protected EWB and LWB groups (696 patients in 12 studies). The risk ratio (RR) is 1.30, [95% CI 0.74 to 2.30], I. 2. = 0%, P = 0.36). Other complications were rare. The Olerud-Molander Ankle Score (OMAS) was the widely used patient-reported outcome measure after ankle fracture fixation among the studies. The result of the six weeks OMAS analysis (three RCTs) was markedly in favour of the early weight-bearing group (MD = 10.08 [95% CI 5.13 to 15.02], I. 2. = 0%P = <0.0001). Conclusions. The risk of postoperative complications is an essential factor when considering EWB. We found that the overall incidence of surgical site infection was 6%. When comparing the two groups, the incidence was 5.2% and 6.8% for the LWB and EWB groups. This difference is not clinically important. On the other hand, significantly better early functional outcome scores were detected in the EWB group. These results are not without limitations. Protected early weight-bearing following open reduction and internal fixation of ankle fractures is potentially safe and improve short-term functional outcome. Further good-quality randomised controlled trials would be needed before we could draw a more precise conclusion

Introduction. Intraarticular calcaneal fractures often need open reduction and internal fixation (ORIF) with plate osteosynthesis. The wound complication is one of the common problems encountered following this and affects the outcome adversely. Our study was done to assess how far postoperative slab/cast can avert wound complications. Methods. Out of 42 patients with unilateral intraarticular calcaneal fractures, 20 were offered postoperative slab/cast and this was continued for six weeks. The remaining 22 patients were not offered any plaster. All patients were followed-up for two years. Results. The incidence of wound dehiscence was 2 in the plaster group as well as 8 in the non-plaster group and this was statistically significant (p = 0.02). Also, significantly lower heel widening was reported in the plaster group (p = 0.03). Although, there was no significant difference in the patient-reported outcome (Maryland Foot Score) and the incidence of pain between the two groups, the occurrence of neurological deficit following surgery and the postoperative range of movements were comparable in these two groups. Conclusion. Thus, it may be concluded that postoperative plaster application for the initial six weeks could be a low-cost yet effective way to reduce wound complications following plate osteosynthesis in intraarticular calcaneal fractures