Abstract. Objectives. The purpose of this trial is to investigate the safety and efficacy of immediate weight-bearing (IWB) and range of motion exercise regimes following ORIF of unstable ankle fractures with a particular focus on functional outcomes and complication rates. Methods. A pragmatic randomised controlled multicentre trial, comparing IWB in a walking boot and ROM within 24 hours versus NWB and immobilisation in a cast for six weeks, following ORIF of all types of unstable adult ankle fractures. The exclusion criteria are skeletal immaturity and tibial plafond fractures. The primary outcome measure is the functional Olerud-Molander Ankle Score (OMAS). Secondary outcomes include wound infection, displacement of osteosynthesis, the full arc of ankle motion, RAND-36 Item Short Form Survey (SF-36) scoring, time to return to work and postoperative hospital length of stay. Results. We recruited 160 patients with an unstable ankle fracture. Participants’ ages ranged from 15 to 94 years (M = 45.5, SD = 17.2), with 54% identified as female. The mean time from injury to surgical fixation was 1.3 days (0 to 17 days). Patients in the IWB group had a 9.5-point higher mean OMAS at six weeks postoperatively (95% CI 1.48, 17.52) P = 0.021 with a similar result at three months. The complications rate was similar in both groups. The rate of surgical site infection was 4.3%. One patient had DVT, and another patient had a PE, both were randomised to NWB. Length of hospital stay was 1 ± 1.5 (0, 12) for the IWB group vs 1.5 ± 2.5 (0, 19) for the NWB group. Conclusion. In this large multicentre RCT, we investigated WB following ORIF of all ankle fracture patterns in the usual care condition using standard fixation methods. Our result suggests that IWB following ankle fracture fixation is safe and resulted in a better functional outcome

Introduction and Objective. Lower limb fractures are amongst the most common surgically managed orthopaedic injuries, with open reduction and internal fixation (ORIF) as the conventional method of treatment of the fibula. In recent years, dedicated intramedullary implants have emerged for fibula fixation in tandem with the move towards minimally invasive surgery in high-risk patients. This is the largest multicentre review to date with the aim of establishing the clinical outcomes following intramedullary nail (IMN) fixation of the fibula and to identify the absolute indication for fibula IMN fixation. Materials and Methods. A retrospective study of adult patients in all UK hospitals, who underwent fibula nail fixation between 01/01/2018 and 31/10/2020 was performed. Primary outcome measures included time to union, infection rate, other post-operative complications associated with the fixation and length of hospital stay. The secondary outcome measure was to identify the indication for fibula nailing. Data tabulation was performed using Microsoft Excel and analysis was performed using SPSS Version 23 (SPSS Statistics). Results. 2 Major Trauma Centres (MTCs) and 9 Trauma Units (TUs) were eligible for inclusion. 102 patients were included and 91% were classified as ankle fractures of 68% (n=69) were Weber B, 24% (n=24) Weber C and 8% (n=9) were either distal tibial fractures with an associated fibula fracture or pilon fractures. The mean age was 64 years of which 45 were male patients and 57 were female. The average BMI was 30.03kg/m. 2. and 44% of patients were ASA 3. 74% of patients had poor pre-op skin condition including swelling and open wounds. The calculated infection rate for fibula nail was 4.9% and metal-work complication rate was 4.9%. The average time to union was 13 weeks and length of inpatient stay was 15 days (SD +/− 12 days). Conclusions. MEFNO has demonstrated that fibula nail is an ideal implant in patients who have a physiologically higher risk of surgery, poor skin condition and a complex fracture pattern. The time to union, complication and infection risks are lower than that reported in literature for ankle ORIFs

Introduction and Objective. Ankle fractures are common and affect young adults as well as the elderly. An unstable ankle fracture treatment typically involves surgical fixation, immobilisation, and modified weight-bearing for six weeks. Non-weight bearing (NWB) cast immobilisation periods were used to protect the soft tissue envelope and osteosynthesis. This can have implications on patient function and may reduce independence, mobility and return to work. Newer trends in earlier mobilisation compete with traditional NWB doctrine, and weak consensus exists as to the best postoperative strategy. The purpose of this trial is to investigate the safety and efficacy of immediate weight-bearing (IWB) and range of motion (ROM) exercise regimes following ORIF of unstable ankle fractures with a particular focus on functional outcomes and complication rates. Materials and Methods. A pragmatic randomised controlled multicentre trial, comparing IWB in a walking boot and ROM within 24 hours versus non-weight-bearing (NWB) and immobilisation in a cast for six weeks, following ORIF of all types of unstable adult ankle fractures (lateral malleolar, bimalleolar, trimalleolar with or without syndesmotic injury). The exclusion criteria are skeletal immaturity and tibial plafond fractures. The primary outcome measure is the functional Olerud-Molander Ankle Score (OMAS). Secondary outcomes include wound infection (deep and superficial), displacement of osteosynthesis, the full arc of ankle motion (plantar flexion and dorsal flection), RAND-36 Item Short Form Survey (SF-36) scoring, time to return to work and postoperative hospital length of stay. Results. We recruited 160 patients with an unstable ankle fracture. Participants’ ages ranged from 15 to 94 years (M = 45.5, SD = 17.2), with 54% identified as female. The mean time from injury to surgical fixation was 1.3 days (0 to 17 days). Patients in the immediate weight-bearing group had a 9.5-point higher mean OMAS at six weeks postoperatively (95% CI 1.48, 17.52) P = 0.021. The complications rate was similar in both groups. The rate of surgical site infection was 4.3%. One patient had DVT, and another patient had a pulmonary embolism; both were randomised to NWB. Length of hospital stay (LOS) was 1 ± 1.5 (0, 12) for the IWB group vs 1.5 ± 2.5 (0, 19) for the NWB group. Conclusions. There is a paucity of quality evidence supporting the postoperative management regimes used most commonly in clinical practice. To our knowledge, immediate weight-bearing (IWB) following ORIF of all types of unstable ankle fractures has not been investigated in a controlled prospective manner in recent decades. In this large multicentre, randomised controlled trial, we investigated immediate weight-bearing following ORIF of all ankle fracture patterns in the usual care condition using standard fixation methods. Our result suggests that IWB following ankle fracture fixation is safe and resulted in a better functional outcome. Once anatomical reduction and stable internal fixation is achieved, we recommend IWB in all types of ankle fractures in a compliant patient

Introduction

Exercise is recommended as first-line treatment for patients with hip osteoarthritis (OA). Interestingly, content and dose of exercise interventions seem to be important for the effect of exercise interventions, but the optimal content and dose is unknown. This warrants randomized controlled trials providing evidence for the optimal exercise program in Hip OA. The aim of this trial was to investigate whether progressive resistance training (PRT) is superior to neuromuscular exercise (NEMEX) for improving functional performance, hip pain and hip-related quality of life in patients with hip OA.

A number of classification systems exist for posterior malleolus fractures of the ankle. The reliability of these classification systems remains unclear. The primary aim of this study was to evaluate the reliability of three commonly utilised fracture classification systems of the posterior malleolus.

60 patients across 2 hospitals sustaining an unstable ankle fracture with a posterior malleolus fragment were identified. All patients underwent radiographs and computed tomography of their injured ankle. 9 surgeons including pre-ST3 level, ST3-8 level, and consultant level applied the Haraguchi, Rammelt, and Mason & Molloy classifications to these patients, at two timepoints, at least 4 weeks apart. The order was randomised between assessments. Inter-rater reliability was assessed using Fleiss’ kappa and 95% confidence intervals (CI). Intra-rater reliability was assessed using Cohen's Kappa and standard error (SE).

Inter-rater reliability (Fleiss’ Kappa) was calculated for the Haraguchi classification as 0.522 (95% CI 0.490 – 0.553), for the Rammelt classification as 0.626 (95% CI 0.600 – 0.652), and the Mason & Molloy classification as 0.541 (95% CI 0.514 – 0.569). Intra-rater reliability (Cohen's Kappa) was 0.764 (SE 0.034) for the Haraguchi, 0.763 (SE 0.031) for the Rammelt, 0.688 (SE 0.035) for the Mason & Molloy classification.

This study reports the inter-rater and intra-rater reliability for three classification systems for posterior malleolus fractures. Based on definitions by Landis & Koch (1977), inter-rater reliability was rated as ‘moderate’ for the Haraguchi and Mason & Molloy classifications; and ‘substantial’ for the Rammelt classification. Similarly, the intra-rater reliability was rated as ‘substantial’ for all three classifications.

Metacarpal fractures represent up to 33% of all hand fractures; of which the majority can be treated non-operatively. Previous research has shown excellent putcomes with non-operative treatment yet surgical stabilisation is recommended to avoid malrotation and symptomatic shortening. It is unknown whether operative is superior to non-operative treatment in oblique or spiral metacarpal shaft fractures.

The aim of the study was to compare non-operative treatment of mobilisation with open surgical stabilisation.

42 adults (≥ 18 years) with a single displaced oblique or spiral metacarpal shaft fractures were randomly assigned in a 1:1 pattern to either non-operative treatment with free mobilisation or operative treatment with open reduction and fixation with lag screws in a prospective study. The primary outcome measure was grip-strength in the injured hand in comparison to the uninjured hand at 1-year follow-up. The Disabilities of the Arm, Shoulder and Hand Score, ranges of motion, metacarpal shortening, complications, time off work, patient satisfaction and costs were secondary outcomes.

All 42 patients attended final follow-up after 1 year. The mean grip strength in the non-operative group was 104% (range 73–250%) of the contralateral hand and 96% (range 58–121%) in the operatively treated patients. Mean metacarpal shortening was 5.0 (range 0–9) mm in the non-operative group and 0.6 (range 0–7) mm in the operative group. There were five minor complications and three revision operations, all in the operative group.

The costs for non-operative treatment were estimated at 1,347 USD compared to 3,834USD for operative treatment; sick leave was significantly longer in the operative group (35 days, range 0–147) than in the non-operative group (12 days, range 0–62) (p=0.008).

When treated with immediate free mobilization single, patients with displaced spiral or oblique metacarpal shaft fractures have outcomes that are comparable to those after operative treatment, despite some metacarpal shortening. Complication rates, costs and sick leave are higher with operative treatment. Early mobilisation of spiral or long oblique single metacarpal fractures is the preferred treatment.

Trial registration number: ClinicalTrials.gov NCT03067454

Introduction

Patients with external fixators are at risk of pin site infection. A more objective assessment of possible pin site infection is warranted, particularly for future home-based monitoring of pin sites. The aim was to determine if thermography can detect signs of inflammation around pin sites by 1) Establishing a maximum temperature cut-off value 2) Investigating the correlation between local temperature and visual signs of inflammation 3) Adjust for anatomical location and ambient room temperature.

Abstract

Abstract

Pseudoarthrosis after spinal fusion is an important complication leading to revision spine surgeries. Iliac Crest Bone Graft is considered the gold standard, but with limited availability and associated co-morbidities, spine surgeons often utilize alternative bone grafts.

Determine the non-inferiority of a novel submicron-sized needle-shaped surface biphasic calcium phosphate (BCP<µm) as compared to autograft in instrumented posterolateral spinal fusion.

Adult patients indicated for instrumented posterolateral spinal fusion of one to six levels from T10-S2 were enrolled at five participating centers. After instrumentation and preparation of the bone bed, the randomized allocation side of the graft type was disclosed. One side was grafted with 10cc of autograft per level containing a minimum of 50% iliac crest bone. The other side was grafted with 10cc of BCP<µm granules standalone (without autograft or bone marrow aspirate). In total, 71 levels were treated. Prospective follow-up included adverse events, Oswestry Disability Index (ODI), and a fine-cut Computerized Tomography (CT) at one year. Fusion was systematically scored as fused or not fused per level per side by two spine surgeons blinded for the procedure.

The first fifty patients enrolled are included in this analysis (mean age: 57 years; 60% female and 40% male). The diagnoses included deformity (56%), structural instability (28%), and instability from decompression (20%). The fusion rate determined by CT for BCP<μm was 76.1%, which compared favorably to the autograft fusion rate of 43.7%. Statistical analysis through binomial modeling showed that the odds of fusion of BCP<μm was 2.54 times higher than that of autograft. 14% of patients experienced a procedure or possible device-related severe adverse event and there were four reoperations. Oswestry Disability Index (ODI) score decreased from a mean of 46.0 (±15.0) to a mean of 31.7 (±16.9), and 52.4% of patients improved with at least 15-point decrease.

This data, aiming to determine non-inferiority of standalone BCP<μm as compared to autograft for posterior spinal fusions, is promising. Ongoing studies to increase the power of the statistics with more patients are forthcoming.

Patients ≤ 55 years have a high primary TKA revision rate compared to patients >55 years. Guided motion knee devices are commonly used in younger patients yet outcomes remain unknown. In this sub-group analysis of a large multicenter study, 254 TKAs with a second-generation guided motion knee implant were performed between 2011–2017 in 202 patients ≤ 55 years at seven US and three European sites. Revision rates were compared with Australian Joint Registry (AOANJRR) 2017 data. Average age 49.7 (range 18–54); 56.4% females; average BMI 34 kg/m2; 67.1% obese; patellae resurfaced in 98.4%. Average follow-up 4.2 years; longest follow-up six years; 27.5% followed-up for ≥ five years. Of eight revisions: total revision (one), tibial plate replacements (three), tibial insert exchanges (four). One tibial plate revision re-revised to total revision. Revision indications were mechanical loosening (n=2), infection (n=3), peri-prosthetic fracture (n=1), and instability (n=2). The Kaplan-Meier revision estimate was 3.4% (95% C.I. 1.7% to 6.7%) at five years compared to AOANJRR rate of 6.9%. There was no differential risk by sex. The revision rate of the second-generation guided motion knee system is lower in younger patients compared to registry controls.

Outcomes for guided motion primary total knee arthroplasty (TKA) in obese patients are unknown. 1,684 consecutive patients underwent 2,059 primary TKAs with a second-generation guided motion implant between 2011–2017 at three European and seven US sites. Of 2,003 (97.3%) TKAs in 1,644 patients with BMI data: average age 64.5 years; 58.4% females; average BMI 32.5 kg/m2; 13.4% had BMI ≥ 40 kg/m2. Subjects with BMI ≥ 40 kg/m2 had longest length of hospital stay (LOS) at European sites; LOS similar at US sites. Subjects with BMI ≥ 40 kg/m2 (P=0.0349) had longest surgery duration. BMI ≥ 40 kg/m2 had more re-hospitalizations or post-TKA reoperations than BMI < 40 kg/m2 (12.7% and 9.2% at five-year post-TKA, P<0.0495). Surgery duration and long-term complication rates are higher in patients with BMI ≥ 40 kg/m2, but device revision risk is not elevated.

Summary

Anatomical variations in hip joint anatomy are associated with both the presence and location of tibiofemoral osteoarthritis (OA).

Summary

Alignment results did not differ between PSG and conventional instrumentation. A small reduction in operation time and blood loss was found with the PSG system, but is unlikely of clinical significance. Length of hospital stay was identical for both groups.

The objective of this trial was to investigate the efficacy of a Comfrey root extract cream in patients with acute upper or lower back pain. The study was conducted as a double-blind, multi-centre, parallel group design RCT over a period of 5 ± 1 days. The patients (n=120, mean age 36.9 years, 46.7 % female) were treated three times a day, 4 g cream per application. The trial included four visits.

The primary efficacy variable was the area-under-the-curve (AUC) of the Visual Analogue Scale (VAS) on active standardised movement values at visits 1 to 4. Among the secondary objectives were back pain at rest (VAS), pressure algometry (pain-time curve; AUC over 5 days), global assessment of efficacy by the patient and investigator, and functional impairment measured with the Oswestry Disability Index.

There was a significant treatment difference between verum and placebo. In the course of the trial the primary variable decreased on average (median) about 95,2 % in the Comfrey extract group and 37.8 % in the placebo group. The results separated by pain location show an equivalent effect of comfrey extract: Regarding pain at rest, in lower back pain a reduction of 98% were observed, in upper back pain 96.9%.

The results of this RCT were clear-cut and consistent across all variables. Comfrey root extract cream showed a remarkably potent and clinically relevant effect in reducing acute back pain. For the first time a fast-acting effect of the ointment (1 hour) was also witnessed in this trial.

Partial meniscectomy patients have a greater likelihood for the development of early osteoarthritis (OA). To prevent the onset of early OA, patient-specific treatment algorithms need to be created that predict patient risk to early OA after meniscectomy. The aim of this work was to identify patient-specific risk factors in partial meniscectomy patients that could potentially lead to early OA. Partial meniscectomy patients operated between 01/2017 and 12/2019 were evaluated in the study (n=317). Exclusion criteria were other pathologies or surgeries for the evaluated knee and meniscus (n = 114). Following informed consent, an online questionnaire containing demographics and the “Knee Injury and Osteoarthritis Outcome Score” (KOOS) questionnaire was sent to the patient. Based on the KOOS pain score, patients were classified into “low” (> 75) and “high” (< 75) risk patients, indicating risk to symptomatic OA. The “high risk” patients also underwent a follow-up including an MRI scan to understand whether they have developed early OA. From 203 participants, 96 patients responded to the questionnaire (116 did not respond) with 61 patients considered “low-risk” and 35 “high-risk” patients. Groups that showed a significant increased risk for OA were patients aged > 40 years, females, overweight (BMI >25 kg/m2 ≤ 30 kg/m2), and smokers (*p < 0.05). The “high-risk”-follow-up revealed a progression of early osteoarthritic cartilage changes in seven patients, with the remaining nineteen patients showing no changes in cartilage status or pain since time of operation. Additionally, eighteen patients in the high-risk group showed a varus or valgus axis deviation. Patient-specific factors for worse postoperative outcomes after partial meniscectomy and indicators for an “early OA” development were identified, providing the basis for a patient-specific treatment approach. Further analysis in a multicentre study and computational analysis of MRI scans is ongoing to develop a patient-specific treatment algorithm for meniscectomy patients

Introduction. Knee arthroplasty (KA), encompassing Total Knee Replacement (TKR) and Unicompartmental Knee Replacement (UKR), is one of the most common orthopedic procedures, aimed at alleviating severe knee arthritis. Postoperative KA management, especially radiographic imaging, remains a substantial financial burden and lacks standardised protocols for its clinical utility during follow-up. Method. In this retrospective multicentre cohort study, data were analysed from January 2014 to March 2020 for adult patients undergoing primary KA at Imperial NHS Trust. Patients were followed over a five-year period. Four machine learning models were developed to evaluate if post-operative X-ray frequency can predict revision surgery. The best-performing model was used to assess the risk of revision surgery associated with different number of X-rays. Result. The study assessed 289 knees with a 2.4% revision rate. The revision group had more X-rays on average than the primary group. The best performing model was Logistic Regression (LR), which indicated that each additional X-ray raised the revision risk by 52% (p<0.001). Notably, having four or more X-rays was linked to a three-fold increase in risk of revision (OR=3.02; p<0.001). Our results align with the literature that immediate post-operative X-rays have limited utility, making the 2nd post-operative X-ray of highest importance in understanding the patient's trajectory. These insights can enhance management by improving risk stratification for patients at higher revision surgery risk. Despite LR being the best-performing model, it is limited by the dataset's significant class imbalance. Conclusion. X-ray frequency can independently predict revision surgery. This study provides insights that can guide surgeons in evidence-based post-operative decision-making. To use those findings and influence post-operative management, future studies should build on this predictive model by incorporating a more robust dataset, surgical indications, and X-ray findings. This will allow early identification of high-risk patients, allowing for personalised post-operative recommendations

Is Non-Weight-Bearing Necessary? (INWN) is a pragmatic multicentre randomised controlled trial comparing immediate protected weight-bearing (IWB) with non-weight-bearing cast immobilisation (NWB) following ankle fracture fixation (ORIF). This trial compares; functional outcomes, complication rates and performs an economic analysis to estimate cost-utility. IWB within 24hrs was compared to NWB, following ORIF of all types of unstable ankle fractures. Skeletally immature patients and tibial plafond fractures were excluded. Functional outcomes were assessed by the Olerud-Molander Ankle Score (OMAS) and RAND-36 Item Short Form Survey (SF-36) taken at regular follow-up intervals up to one year. A cost-utility analysis via decision tree modelling was performed to derive an incremental cost effectiveness ratio (ICER). A standard gamble health state valuation model utilising SF-36 scores was used to calculate Quality Adjusted Life Years (QALYs) for each arm. We recruited 160 patients (80 per arm), aged 15 to 94 years (M = 45.5), 54% female. Complication rates were similar in both groups. IWB demonstrated a consistently higher OMAS score, with significant values at 6 weeks (MD=10.4, p=0.005) and 3 months (MD 12.0, p=0.003). Standard gamble utility values demonstrated consistently higher values (a score of 1 equals perfect health) with IWB, significant at 3 months (Ẋ = 0.75 [IWB] / 0.69 [NWB], p=0.018). Cost-utility analysis demonstrated NWB is €798.02 more expensive and results in 0.04 fewer QALYs over 1 year. This results in an ICER of −€21,682.42/QALY. This negative ICER indicates cost savings of €21,682.42 for every QALY (25 patients = 1 QALY gain) gained implementing an IWB regime. IWB demonstrates a superior functional outcome, greater cost savings and similar complication rates, compared to NWB following ankle fracture fixation

Introduction. Polyacrylamide hydrogel (iPAAG. 1. ), is CE marked for treating symptomatic knee osteoarthritis (OA), meeting the need for an effective, long-lasting, and safe non-surgical option. This study evaluates the efficacy and safety of a single 6 ml intra-articular injection of iPAAG in participants with moderate to severe knee OA over a 5-year post-treatment period, presenting data from the 4-year follow up. Method. This prospective multicentre study (3 sites in Denmark) involved 49 participants (31 females) with an average age of 70 (range 44 – 86 years). They received a single 6 mL iPAAG injection. All participants provided informed consent and re-consented to continue after 1 year. The study followed GCP principles and was approved by Danish health authorities and local Health Research Ethics committees. Twenty-seven participants completed the 4-year follow-up. The study evaluated WOMAC pain, stiffness, function, and Patient Global Assessment (PGA) of disease impact. Changes from baseline were analysed using a mixed model for repeated measurement (MMRM). Sensitivity analyses were applied on the extension data, where the MMRM analysis was repeated only including patients in the extension phase and an ANCOVA model was used, replacing missing values at 4-years with baseline values (BOCF). Results. The planned MMRM analysis (n=49) revealed a statistically significant decrease in WOMAC pain subscale scores (-22.0; 95%CI: -29.5; -14.4) from baseline to 4-years. Analysis of the extension phase (n=27) showed similar results (-21.8; 95%CI: -29.0; -14.6) compared to the initial analysis. Furthermore, BOCF analysis indicated a statistically significant reduction in WOMAC pain subscale scores from baseline (-13.0 units). Four new adverse events were reported between the 3-year and 4-year visits; none were related to treatment. Conclusions. This study shows that single injections of 6 ml intra-articular iPAAG were well tolerated and continued to provide clinically important effectiveness at 4-years after treatment. Acknowledgements. The study was sponsored by Contura International A/S

The World Health Organisation (WHO) has included low back pain in its list of twelve priority diseases. Notably, Degenerative disc disease (DDD) presents a large, unmet medical need which results in a disabling loss of mechanical function. Today, no efficient therapy is available. Chronic cases often receive surgery, which may lead to biomechanical problems and accelerated degeneration of adjacent segments. Our consortium partners have developed and studied mesenchymal stem cell-based, regenerative therapies trials. In previous phase 2 trial, patients exhibited rapid and progressive improvement of functional and pain indexes after 1 year with no significant side effects. To develop the world's first rigorously proven, effective treatment of DDD, EUROSPINE aims to assess, via a multicentre, randomized, controlled, phase 2b clinical trial including 112 patients with DDD, the efficacy of an allogenic intervertebral mesenchymal stem cell (MSC)-based therapy. This innovative therapy aims to rapidly and sustainably (at least 24 months) reduce pain and disability. In addition, the consortium aims to provide new knowledge on immune response & safety associated with allogeneic BM-MSC intradiscal injection. This simple procedure would be cost-effective, minimally invasive, and standardised. At the end of the RESPINE trial, we aim to propose a broadly available and clinically applicable treatment for DDD, marketed by European SMEs