Acetabular Fractures in older patients Intervention Trial (AceFIT): a feasibility triple-arm randomized controlled study.

Aims: To assess the feasibility of a randomized controlled trial (RCT) that compares three treatments for acetabular fractures in older patients: surgical fixation, surgical fixation and hip arthroplasty (fix-and-replace), and non-surgical treatment. Methods: Patients were recruited from seven UK NHS centres and randomized to a three-arm pilot trial if aged older than 60 years and had a displaced acetabular fracture. Feasibility outcomes included patients' willingness to participate, clinicians' capability to recruit, and dropout rates. The primary clinical outcome measure was the EuroQol five-dimension questionnaire (EQ-5D) at six months. Secondary outcomes were Oxford Hip Score, Disability Rating Index, blood loss, and radiological and mobility assessments. Results: Between December 2017 and December 2019, 60 patients were recruited (median age 77.4 years, range 63.3 to 88.5) (39/21 M/F ratio). At final nine-month follow-up, 4/60 (7%) had withdrawn, 4/60 (7%) had died, and one had been lost to follow-up; a 98% response rate (50/51) was achieved for the EQ-5D questionnaire. Four deaths were recorded during the three-year trial period: three in the non-surgical treatment group and one in the fix-and-replace group. Conclusion: This study has shown a full-scale RCT to be feasible, but will need international recruitment. The Acetabular Fractures in older patients Intervention Trial (AceFIT) has informed the design of a multinational RCT sample size of 1,474 or 1,974 patients for a minimal clinically important difference of 0.06 on EQ-5D, with a power of 0.8 or 0.9, and loss to follow-up of 20%. This observed patient cohort comprises a medically complex group requiring multidisciplinary care; surgeon, anaesthetist, and ortho-geriatrician input is needed to optimize recovery and rehabilitation.

The floating hip injury: a descriptive study and case-control analysis.

PURPOSE: A "floating hip" (FH) injury is a rare injury describing the simultaneous ipsilateral fracture of the femur and pelvis or acetabulum (P/A). We describe our experience with patients presenting with FH injuries and compare them to controls with similar P/A fractures but without femoral involvement. METHODS: Medical records and radiographs of FH patients and controls presenting to our tertiary centre between 2015 and 2020 were reviewed. Follow-up data from outpatient clinical records were also extracted. The control group were extensively matched by age, sex, body mass index, fracture classification and energy of injury. RESULTS: From 1392 recorded P/A fractures, 42 FH cases were identified (average age 39 years, 78.6% males). The most common femoral fracture was the midshaft (35.7%), followed by the neck of femur (26.2%). 90.5% of FH injuries were due to high-energy mechanisms. 64.3% of P/A fractures, and 100% of femoral fractures were managed surgically. Compared to controls, FH cases were more likely to have additional orthopaedic injuries (73.8% vs. 40.5%, p = 0.002), more total theatre admissions (mean 2.5 vs. 1.19, p < 0.001), longer hospital stays (28.3 vs. 14.9 days, p = 0.02), and a higher rates of post-op complications (53.8% vs. 20%, p = 0.025). CONCLUSIONS: We report differences in the presentation, management, and outcomes of FH injuries versus controls, even after extensive matching for confounders. These differences may inform future treatment strategies for the FH injury.

Platelet-rich plasma injection for acute Achilles tendon rupture : two-year follow-up of the PATH-2 randomized, placebo-controlled, superiority trial.

AIMS: To determine whether platelet-rich plasma (PRP) injection improves outcomes two years after acute Achilles tendon rupture. METHODS: A randomized multicentre two-arm parallel-group, participant- and assessor-blinded superiority trial was undertaken. Recruitment commenced on 28 July 2015 and two-year follow-up was completed in 21 October 2019. Participants were 230 adults aged 18 years and over, with acute Achilles tendon rupture managed with non-surgical treatment from 19 UK hospitals. Exclusions were insertion or musculotendinous junction injuries, major leg injury or deformity, diabetes, platelet or haematological disorder, medication with systemic corticosteroids, anticoagulation therapy treatment, and other contraindicating conditions. Participants were randomized via a central online system 1:1 to PRP or placebo injection. The main outcome measure was Achilles Tendon Rupture Score (ATRS) at two years via postal questionnaire. Other outcomes were pain, recovery goal attainment, and quality of life. Analysis was by intention-to-treat. RESULTS: A total of 230 participants were randomized, 114 to PRP and 116 to placebo. Two-year questionnaires were sent to 216 participants who completed a six-month questionnaire. Overall, 182/216 participants (84%) completed the two-year questionnaire. Participants were aged a mean of 46 years (SD 13.0) and 25% were female (57/230). The majority of participants received the allocated intervention (219/229, 96%). Mean ATRS scores at two years were 82.2 (SD 18.3) in the PRP group (n = 85) and 83.8 (SD 16.0) in the placebo group (n = 92). There was no evidence of a difference in the ATRS at two years (adjusted mean difference -0.752, 95% confidence interval -5.523 to 4.020; p = 0.757) or in other secondary outcomes, and there were no re-ruptures between 24 weeks and two years. CONCLUSION: PRP injection did not improve patient-reported function or quality of life two years after acute Achilles tendon rupture compared with placebo. The evidence from this study indicates that PRP offers no patient benefit in the longer term for patients with acute Achilles tendon rupture.Cite this article: Bone Joint J 2022;104-B(11):1256-1265.

Fix and replace: Simultaneous fracture fixation and hip replacement for acetabular fractures in older patients.

INTRODUCTION: Displaced acetabular fractures in the elderly present significant treatment challenges. The 'fix and replace' concept involves open reduction and internal fixation of the acetabulum, providing bony stability to accept the press-fit of an acetabular cup, with a cemented femoral stem. This allows early mobilisation and the advantages this confers. This study of 57 patients treated with fix and replace describes our technique, outcomes, and survival analysis. METHODS: A retrospective review of 57 'fix and replace' procedures in patients aged over 60 was performed. Data was collected on mechanism, fracture type, demographics, time to surgery, comorbidity index, complications, EQ-5D and Oxford hip scores (OHS). Radiographs were reviewed for fracture healing, implant loosening, cup migration, and heterotopic ossification. RESULTS: 57 patients aged 60 to 95 had fix and replace surgery. The median ASA score was 3. The mean Charlson Index was 4.8. 45 patients had a low-energy fall, 6 had a road traffic accident, 3 fell off a bicycle, and 1 mechanism was unclear. The fracture patterns were anterior column posterior hemitransverse (67%), associated both columns (9%), posterior column (9%), posterior column and posterior wall (9%), and transverse (2%). The mean time to surgery was 8.4 days (0-14). 26 out of 57 (46%) received a blood transfusion. Mean length of stay was 17.6 days (7-86). The mean follow-up was 35.5 months. 4 dislocations were treated with closed reduction, whilst 1 required excision arthroplasty. 2 infections resolved with debridement, antibiotics, and implant retention (DAIR), whilst 1 required a two-stage revision. 1 acetabular component had migrated requiring revision. The median pre-injury OHS was 44 (26-48) compared to 37.3 (28-48) at 1 year. There were no deaths at 30-days, whilst at 1 year 7 patients had died. Kaplan Meier survival analysis showed mean survival was 1984.5 days. Implant survival was 90% at 1 year. CONCLUSION: While fix and replace is conceptually attractive, this medically complex patient group requires considerable support peri­ and post-operatively. Further studies are required to provide clinicians with more information to decide on how best to provide a holistic management strategy for such injuries in this frail patient cohort.

Primary stability of a proximally coated and tapered stem.

AIMS: The aim of this prospective cohort study was to evaluate the early migration of the TriFit cementless proximally coated tapered femoral stem using radiostereometric analysis (RSA). METHODS: A total of 21 patients (eight men and 13 women) undergoing primary total hip arthroplasty (THA) for osteoarthritis of the hip were recruited in this study and followed up for two years. Two patients were lost to follow-up. All patients received a TriFit stem and Trinity Cup with a vitamin E-infused highly cross-linked ultra-high molecular weight polyethylene liner. Radiographs for RSA were taken postoperatively and then at three, 12, and 24 months. Oxford Hip Score (OHS), EuroQol five-dimension questionnaire (EQ-5D), and adverse events were reported. RESULTS: At two years, the mean subsidence of the head and tip for the TriFit stem was 0.38 mm (SD 0.32) and 0.52 mm (SD 0.36), respectively. The total migration of the head and tip was 0.55 mm (SD 0.32) and 0.71 mm (SD 0.38), respectively. There were no statistically significant differences between the three to 12 months' migration (p = 0.105) and 12 to 24 months' migration (p = 0.694). The OHS and EQ-5D showed significant improvements at two years. CONCLUSION: The results of this study suggest that the TriFit femoral stem achieves initial stability and is likely to be stable in the mid and long term. A long-term outcome study is required to assess late mechanisms of failure and the effects of bone mineral density (BMD) related changes. Cite this article: Bone Joint J 2021;103-B(4):644-649.

Characteristics of L-PRP preparations for treating Achilles tendon rupture within the PATH-2 study.

Platelet-rich plasma (PRP) is an autologous preparation that has been claimed to improve healing and mechanobiological properties of tendons both in vitro and in vivo. In this sub-study from the PATH-2 (PRP in Achilles Tendon Healing-2) trial, we report the cellular and growth factor content and quality of the Leukocyte-rich PRP (L-PRP) (N = 103) prepared using a standardized commercial preparation method across 19 different UK centers. Baseline whole blood cell counts (red cells, leukocyte and platelets) demonstrated that the two groups were well-matched. L-PRP analysis gave a mean platelet count of 852.6 x 109/L (SD 438.96), a mean leukocyte cell count of 15.13 x 109/L (SD 10.28) and a mean red blood cell count of 0.91 x 1012/L (SD 1.49). The activation status of the L-PRP gave either low or high expression levels of the degranulation marker CD62p before and after ex-vivo platelet activation respectively. TGF-ß, VEGF, PDGF, IGF and FGFb mean concentrations were 131.92 ng/ml, 0.98 ng/ml, 55.34 ng/ml, 78.2 ng/ml and 111.0 pg/ml respectively with expected correlations with both platelet and leukocyte counts. While PATH-2 results demonstrated that there was no evidence L-PRP is effective for improving clinical outcomes at 24 weeks after Achilles tendon rupture, our findings support that the majority of L-PRP properties were within the method specification and performance.

Outcome of revision surgery in recurrent dislocation of primary total hip arthroplasty.

BACKGROUND: The cause of recurrent dislocation following primary total hip arthroplasty (THA) is multifactorial. A re-dislocation rate of up-to 34% following revision is reported. The aim of this study was to determine the re-dislocation rates following revision for recurrent THR dislocation. METHODOLOGY: Patients who underwent revision for recurrent dislocation between January 2008 and January 2015 were identified. We identified the date and type of primary implant, overall number and reasons for dislocation, revision implant details and complication data. RESULTS: Over an 8-year period, 24 patients underwent revision. The median age was 77 (68-85) years, median time to first dislocation was 78 (23-160) months and median number of dislocations was 3 (2-4) with a mean follow-up of 18 months. Socket Mal-Orientation (10) and Abductor deficiency (5) were the main causes of recurrent dislocation. 21 patients (88%) underwent revision of both components, 1 patient underwent isolated cup revision and 2 patients had revision of acetabular component with insertion of a BioBall. There were no dislocations within 90 days of revision surgery. 4 patients had late dislocations (3 recurrent, 1 isolated). There was no significant increase risk of dislocation after revision surgery in the neck of femur group (p = 0.467). CONCLUSIONS: We report favourable outcomes for revision of both components for recurrent dislocation with no dislocations within 90 days. The overall late dislocation rate was 16.7%, however, these patients have settled following closed reduction. Due to its multifactorial aetiology, both component revision can be considered in this patient population.

Platelet rich plasma injection for acute Achilles tendon rupture: PATH-2 randomised, placebo controlled, superiority trial.

OBJECTIVE: To determine whether an injection of platelet rich plasma improves outcomes after acute Achilles tendon rupture. DESIGN: Randomised, placebo controlled, two arm, parallel group, participant and assessor masked, superiority trial. SETTING: Secondary care trauma units across 19 hospitals in the United Kingdom's health service. PARTICIPANTS: Recruitment commenced in July 2015 and follow-up was completed in March 2018. 230 adults aged 18 years and over were included, with acute Achilles tendon rupture presenting within 12 days of injury and managed with non-surgical treatment. Exclusions were injury at the insertion or musculotendinous junction, major leg injury or deformity, diabetes mellitus, platelet or haematological disorder, systemic corticosteroids, anticoagulation treatment, and other contraindicating conditions. INTERVENTIONS: Participants were randomised 1:1 to platelet rich plasma (n=114) or placebo (dry needle; n=116) injection. All participants received standard rehabilitation care (ankle immobilisation followed by physiotherapy). MAIN OUTCOMES AND MEASURES: Primary outcome was muscle tendon function at 24 weeks, measured objectively with the limb symmetry index (injured/uninjured×100) in maximal work done during the heel rise endurance test (an instrumented measure of repeated single leg heel rises until fatigue). Secondary outcomes included patient reported function (Achilles tendon rupture score), quality of life (short form 12 version 2®), pain (visual analogue scale), goal attainment (patient specific functional scale), and adverse events. A central laboratory analysed the quality and content of platelet rich plasma. Analyses were by modified intention to treat. RESULTS: Participants were 46 years old on average, and 57 (25%) of 230 were female. At 24 weeks, 202 (88%) participants completed the heel rise endurance test and 216 (94%) the patient reported outcomes. The platelet rich plasma was of good quality, with expected growth factor content. No difference was detected in muscle tendon function between participants receiving platelet rich plasma injections and those receiving placebo injections (limb symmetry index, mean 34.7% (standard deviation 17.7%) v 38.5% (22.8%); adjusted mean difference -3.9% (95% confidence interval -10.5% to 2.7%)) or in any secondary outcomes or adverse event rates. Complier average causal effect analyses gave similar findings. CONCLUSIONS: There is no evidence to indicate that injections of platelet rich plasma can improve objective muscle tendon function, patient reported function, or quality of life after acute Achilles tendon rupture compared with placebo, or that they offer any patient benefit. TRIAL REGISTRATION: ISRCTN54992179.

Early Surgical Stabilization of Complex Chest Wall Injuries Improves Short-Term Patient Outcomes.

BACKGROUND: This study aimed to assess the outcome of patients undergoing internal fixation of complex rib fractures in a U.K. major trauma center. METHODS: A retrospective analysis was performed on all patients undergoing operative fixation of rib fractures from March 2014 to May 2016. Outcome measures included hospital length of stay, intensive care unit (ICU) admission, mechanical ventilation, infection, and mortality. RESULTS: One hundred and two patients (66 male patients and 36 female patients, with a median age of 62 years) underwent rib fracture fixation during the study period. The causes of trauma were road traffic accidents in 39 patients (38%), a fall from a substantial height in 38 patients (37%), and a fall down stairs in 21 patients (21%). Thirty-eight patients (37%) had isolated chest trauma, and 64 patients (63%) had additional injuries. Fifty-three patients (52%) required ICU admission with a mean ICU stay of 4.7 days (range, 1 to 34 days). The median hospital length of stay was 10.6 days (range, 3 to 51 days). Patients with additional injuries (p = 0.01) and those requiring mechanical ventilation (p < 0.0001) stayed significantly longer. Sixty-five patients (64%) underwent rib fixation within 48 hours of the injury, and 37 patients (36%) underwent the surgical procedure after 48 hours. A surgical procedure within 48 hours resulted in a shorter ICU stay (p = 0.01), fewer cases of pneumonia (p = 0.001), reduced duration of mechanical ventilation (p = 0.03) and fewer tracheostomies (p = 0.02), and shorter hospital length of stay (11.5 compared with 17.3 days; p = 0.008). CONCLUSIONS: Surgical stabilization of multiple rib fractures may improve the outcome in patients with multiple injuries and isolated chest wall trauma. Early surgical fixation leads to shorter length of stay and better outcomes. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Platelet-rich plasma in Achilles tendon healing 2 (PATH-2) trial: statistical analysis plan for a multicentre, double-blinded, parallel-group, placebo-controlled randomised clinical trial.

BACKGROUND: There has been a recent steep growth in platelet-rich plasma (PRP) use for musculoskeletal conditions, but findings from high quality clinical trial data are lacking in the literature. Here, we describe the statistical analysis plan (SAP) for the Platelet-rich plasma in Achilles Tendon Healing 2 (PATH-2) trial. METHODS: PATH-2 is a pragmatic, parallel-group, multi-centre, double-blinded, randomised, placebo-controlled, superiority trial. The study aims to evaluate the clinical efficacy of PRP in acute Achilles tendon rupture in terms of muscle-tendon function. Patients are identified in the orthopaedic/trauma outpatient clinic. The primary outcome is muscle-tendon work capacity from the Heel Rise Endurance Test result, expressed as the Limb Symmetry Index (work, in joules), at 24 weeks post randomisation. Multivariate linear regression adjusting for the stratification factors (centre and age) and additional prognostic factors will be used to investigate the adjusted effect of the intervention. The analysis will be by modified intention-to-treat. Sensitivity analysis will assess the internal validity of the trial results by performing a per-protocol analysis. Safety will be summarised by treatment arm for all patients who started treatment. Secondary patient-reported outcome measures will be analysed using linear mixed effects models to allow all data collected at all follow-up points to be considered. Missing data will be summarised and reported by treatment arm. Missing data imputation will be performed, if appropriate. DISCUSSION: The PATH-2 trial will be reported in accordance with the CONSORT statement. This SAP publication will avoid bias arising from prior knowledge of the study results. Any changes or deviations from the current SAP will be described and justified in the final report. TRIAL REGISTRATION: ISRCTN registry: ISRCTN54992179 , assigned 12 January 2015. ClinicalTrials.gov: NCT02302664, received 18 November 2014. UK Clinical Research Network Study Portfolio Database: ID 17850.

Platelet rich Plasma in Achilles Tendon Healing 2 (PATH-2) trial: protocol for a multicentre, participant and assessor-blinded, parallel-group randomised clinical trial comparing platelet-rich plasma (PRP) injection versus placebo injection for Achilles tendon rupture.

BACKGROUND: Achilles tendon injuries give rise to substantial long-lasting morbidity and pose considerable challenges for clinicians and patients during the lengthy healing period. Current treatment strategies struggle to curb the burden of this injury on health systems and society due to lengthy rehabilitation, work absence and reinjury risk. Platelet-rich plasma (PRP) is an autologous preparation that has been shown to improve the mechanobiological properties of tendons in laboratory and animal studies. The use of PRP in musculoskeletal injuries is on the increase despite the lack of adequately powered clinical studies. METHODS AND DESIGN: This is a multicentre randomised controlled trial to evaluate the efficacy and mechanism of PRP in patients with acute Achilles tendon rupture (ATR). All adults with acute ATR presenting within 12 days of the injury who are to be treated non-operatively are eligible. A total of 230 consenting patients will be randomly allocated via a remote web-based service to receive PRP injection or placebo injection to the site of the injury. All participants will be blinded to the intervention and will receive standardised rehabilitation to reduce efficacy interference.Participants will be followed up with blinded assessments of muscle-tendon function, quality of life, pain and overall patient's functional goals at 4, 7, 13, 24 weeks and 24 months post-treatment. The primary outcome is the heel-rise endurance test (HRET), which will be supervised by a blinded assessor at 24 weeks. A subgroup of 16 participants in one centre will have needle biopsy under ultrasound guidance at 6 weeks. Blood and PRP will be analysed for cell count, platelet activation and growth factor concentrations. ETHICS AND DISSEMINATION: The protocol has been approved by the Oxfordshire Research Ethics Committee (Oxfordshire Research Ethics Committee A, reference no 14/SC/1333). The trial will be reported in accordance with the CONSORT statement and published in peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: ISRCTN: 54992179, assigned 12 January 2015. ClinicalTrials.gov: NCT02302664, received 18 November 2014. UK Clinical Research Network Study Portfolio Database: ID 17850.

Effect of platelet-rich plasma on healing tissues in acute ruptured Achilles tendon: a human immunohistochemistry study.

BACKGROUND: Platelet-rich plasma (PRP), an autologous derivative of whole blood that contains a supraphysiological concentration of platelets, is thought to invoke an earlier and improved tissue healing response. This notion has been supported by in-vitro and animal studies in bone, cartilage, tendon, and muscle. To our knowledge no published study exists of the effects of PRP in human tissues in vivo. The aim of our study was to investigate the response of ruptured Achilles tendon treated with PRP. METHODS: Tendon tissue biopsy samples were obtained from 20 patients with ruptured Achilles tendon by means of ultrasound-guided needle biopsies from the healing area of the Achilles tendon 6 weeks after treatment with PRP or placebo controls (10 patients each). All samples were embedded in paraffin wax, sectioned, and stained with haematoxylin and eosin and alcian blue. Immunohistochemistry markers were used to identify collagen I and III, lymphocytes (CD45), proliferation (KI67), and blood vessels (CD34). All images were masked and analysed with Image J software. FINDINGS: Cellularity and glycosaminoglycans content were significantly higher in PRP-treated tendons than in controls (p=0·01 and p<0·001, respectively). Fibre structure of the tissue was significantly better in the PRP group than in the control tissue (p<0·001). Although both groups showed high collagen I staining, content of collagen I was significantly higher in PRP-treated tendons than in control tendons (p=0·0079), whereas collagen III content was not different (p=1·0). The ratio of collagen III to collagen I was significantly lower in PRP samples (p=0·007). There was no significant difference in CD45 expression (p=0·33). However, PRP samples had fewer blood vessels than did control samples (p=0·023). The overall modified Bonar score was significantly lower in PRP samples, which indicates improved early tendon healing. INTERPRETATION: This is the first study, to our knowledge, to report the immunohistochemical response of ruptured human Achilles tendon to PRP. The findings reveal that locally applied PRP enhanced the maturity of the healing tendon tissues by promoting better collagen I deposition, decreased cellularity, less vascularity, and higher glycosaminoglycan content when compared with control samples. Further work is required to determine the longer term effects of the use of PRP in musculoskeletal diseases. FUNDING: National Institute for Health Research.

Quantitative biomechanical comparison of ankle fracture casting methods.

The incidence of ankle fractures is increasing rapidly due to the ageing demographic. In older patients with compromised distal circulation, conservative treatment of fractures may be indicated. High rates of malunion and complications due to skin fragility motivate the design of novel casting systems, but biomechanical stability requirements are poorly defined. This article presents the first quantitative study of ankle cast stability and hypothesises that a newly proposed close contact cast (CCC) system provides similar biomechanical stability to standard casts (SC). Two adult mannequin legs transected at the malleoli, one incorporating an inflatable model of tissue swelling, were stabilised with casts applied by an experienced surgeon. They were cyclically loaded in torsion, measuring applied rotation angle and resulting torque. CCC stiffness was equal to or greater than that of SC in two measures of ankle cast resistance to torsion. The effect of swelling reduction at the ankle site was significantly greater on CCC than on SC. The data support the hypothesis that CCC provides similar biomechanical stability to SC and therefore also the clinical use of CCC. They suggest that more frequent re-application of CCC is likely required to maintain stability following resolution of swelling at the injury site.

The AutoQual ultrasound elastography method for quantitative assessment of lateral strain in post-rupture Achilles tendons.

This paper presents the AutoQual elastography method: a novel algorithm that improves the quality of 2D displacement field calculation from ultrasound radio frequency (RF) sequences of acutely ruptured Achilles tendons to determine image-lateral strain fields and has potential use for ligaments and muscles. This method uses 2D bicubic spline interpolation of the RF signal, Quality Determined Search, Automatic Search Range and Adaptive Block Size components as a novel combination that is designed to improve continuity and decrease displacement field noise, especially in areas of low signal strength. We present a simple experiment for quantitatively comparing the AutoQual method to a multiscale (MS) elastography method from ultrasound RF sequences of a 5% agar phantom for rigid body motion and known lateral strain loads with speeds up to 5mm/s. We finally present examples of four in vivo Achilles tendons in various damage states and with manual or artificially controlled passive flexion of the foot. Results show that the AutoQual method offers a substantial improvement on the MS method, achieving similar performance for rigid body tracking at all speeds, a lower normalized square error at all strains induced and a more continuous strain field at higher compression rates. AutoQual also showed a greater average normalized cross correlation for image blocks in the area of interest, a lower standard deviation of the strain field and a visually more acceptable point tracking for in vivo examples. This work demonstrates lateral ultrasound elastography which is robust to the complex passive motion of the Achilles and to various imaging artifacts associated with imaging tendon rupture. This method potentially has a wide clinical application for assessing in vivo strains in and hence mechanical function of any near skin surface tissues that are longitudinally loaded.