The PATH-2 trial found no evidence of a benefit of Platelet Rich Plasma (PRP) injection versus a placebo after Achilles tendon rupture (ATR) at six-months. ATR often leave longer-term functional deficiencies beyond six-months. This study aim is to determine if PRP affect tendon functional outcomes at two-years after rupture. Randomised multi-centre two-arm parallel-group, participant- and assessor-blinded, superiority trial.Background
Study design
Disability and slow return to sport and work after tendon rupture are major challenges. Platelet Rich Plasma (PRP) is an autologous supraphysiological concentration of platelets from whole blood that has demonstrated positive cellular and physiological effects on healing in laboratory conditions but evidence from adequately powered robust clinical trials is lacking. We aimed to determine the clinical efficacy of PRP for treatment of acute Achilles tendon rupture. In a placebo-controlled, participant- and assessor-blinded, trial at 19 NHS hospitals we randomly assigned 230 adults starting acute Achilles rupture non-surgical management to PRP injection or dry-needle insertion (placebo) to the rupture gap under local anaesthetic. Patients with confounding or contraindicated concurrent medical conditions were excluded. The primary outcome was muscle-tendon function, assessed by the limb symmetry index (LSI, uninjured limb/injured limb × 100, higher scores better) of the work (Joules) performed during the heel-rise endurance test at 24 weeks. Secondary outcomes were: Achilles Tendon Rupture Score (ATRS, 0–100, higher scores better), quality of life (SF-12), pain, and goal attainment. Trial registration: ISRCTN54992179Background
Methods
Current treatment options for displaced acetabular fractures in elderly patients include non-surgical management, surgical fixation and surgical fixation with simultaneous hip replacement, the so-called “fix-and-replace”™. There remains a paucity of evidence to guide surgeons in decision making for these difficult injuries. The aim of this study was to assess the feasibility of performing an appropriately powered RCT between treatment options for acetabular fractures in older patients. This was an NIHR funded feasibility triple-arm RCT with participation from 7 NHS MTCs. Patients older than 60 were recruited if they had an acetabular fracture deemed sufficiently displaced for the treating surgeon to consider surgical fixation. Randomisation was performed on a 1:1:1 basis. The three treatment arms were non-surgical management, surgical fixation and fix-and-replace. Feasibility was assessed by willingness of patients to participate and clinicians to recruit, drop out rate, estimates of standard deviation to inform the sample size calculation for the full trial and completion rates to inform design of a future definitive trial. EQ-5D was the primary outcome measure at 6 months, OHS and Disability Rating Index were secondary outcome measures. Of 117 eligible patients, 60 were randomised whilst 50 declined study participation. Nine patients did not receive their allocated intervention. Analysis was performed on an intention to treat basis. During the study period 4 patients withdrew before final review, 4 patients died and 1 was lost to follow-up. The estimated sample size for a full scale study was calculated to be 1474 participants for an EQ-5D MCID of 0.06 with a power of 0.8. This feasibility study suggests a full scale trial would require international collaboration. This study also has provided observed safety data regarding mortality and morbidity for the fix-and-replace procedure to aid surgeons in the decision-making process when considering treatment options.
To determine whether platelet-rich plasma (PRP) injection improves outcomes two years after acute Achilles tendon rupture. 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.Aims
Methods
Displaced acetabular fractures in the older patient present significant treatment challenges. There is evidence the morbidity and mortality associated is similar to the fractured neck of femur cohort. Despite growing literature, there remains significant controversy regarding treatment algorithms; varying between conservative management, to fracture fixation and finally surgical fixation and simultaneous THA to allow immediate full weight bearing. £250k NIHR, Research for Patient Benefit (Ref: PB-PG-0815-20054). Trial ethical approval (17/EE/0271). After national consultation, 3 arms included; conservative management, fracture fixation and simultaneous fracture fixation with THA. Statistical analysis required minimum 12 patients/3 arms to show feasibility, with an optimum 20/arm. Inclusion criteria; patients >60 years & displaced acetabular fracture. Exclusion criteria: open fracture, THA in situ, pre-injury immobility, polytrauma. Primary outcome measure - ability recruit & EQ-5D-5L at 6 months. Secondary outcome measures (9 months); OHS, Disability Rating Index, radiographs, perioperative physiological variables including surgery duration, blood loss, complications and health economics. 11 UK level 1 major trauma centres enrolled into the trial, commenced December 2017. Failure surgical equipoise was identified as an issue regarding recruitment. Full trial recruitment (60 patients) achieved; 333 patients screened. 66% male, median age 76 (range 63–93), median BMI 25 (range 18–37), 87% full mental capacity, 77% admitted from own home. 75% fall from standing height. 60% fractures; anterior column posterior hemi-transverse. Trial feasibility confirmed December 2020. Presented data- secondary outcomes that are statistically significant in improvement from baseline for only the fix and replace arm, with acceptable trial complications. Issues are highlighted with conservative management in this patient cohort. Our unique RCT informs design and sample size calculation for a future RCT. It represents the first opportunity to understand the intricacies of these treatment modalities. This RCT provides clinicians with information on how best to provide management for this medically complex patient cohort.
There is an increasing acceptance that the clinical outcomes following posterior malleolar fractures are less than satisfactory. In our previous multicenter study (Powell, BOFAS 2016) we showed that the Olerud-Molander Ankle Score (OMAS) was 79 for unimalleolar fractures and 65 for bi malleolar fractures, however it dropped significantly to 54 in trimalleolar fractures. In creating a treatment guiding classification, we report our results in a system change in management of posterior malleolar fractures in our unit. All fractures were classified according to Mason and Molloy classification (BOFAS 2015, FAI 2017) based on CT scans obtained pre-operatively. This dictated the treatment algorithm. Type 1 fractures underwent syndesmotic fixation. Type 2A fractures underwent ORIF through a posterolateral incision, and type 2B and 3 fractures underwent ORIF through a posteromedial incision. The patient remained NWB for 6 weeks postoperative. Data was collected from December 2014 to July 2017.Background
Method
Platelet-Rich Plasma (PRP), an autologous derivative of whole blood that contains a supraphysiological concentration of platelets and growth factors. Most published studies have investigated the effect of PRP-conditioned media on cell cultures. We are not aware of any study that has investigated whole PRP with its cellular components on human tissue cultures. This study aims to investigate the effect of PRP on cell migration from human Achilles tendon explants, and the subsequent cellular proliferative effects in culture. This is an Purpose
Methods
Platelet Rich Plasma (PRP) has been shown to have positive effect in tendon regeneration in in-vitro and limited in-vivo animal studies. We aim to study PRP use in acute Achilles tendon rupture (ATR) regeneration in a purposely designed clinical trial. This is a prospective double-arm patient-blinded randomized controlled trial. ATR patients were randomized into PRP treatment or control groups. Non-operatively treated patients received PRP or control injection in clinic. In operatively treated patients, PRP gel was applied in the ruptured gap during percutaneous repair. Standard rehabilitation protocol was used and patients were followed up for 24 weeks. ATR, VISA-A and FAOS scores were used as subjective outcome measures. Functional ultrasound Elastography (FUSE) was performed at each follow-up to assess the mechanical properties of tendons. PRP analysis and tendon needle-biopsy were performed to study the histological differences during healing in both groups.Purpose
Methods
It has been suggested that the transition phases of implementing daylight saving time (DST) may impact on serious or fatal injuries sustained as the result of road traffic collision (RTC). The aim of this study is to explore the effects of transitions into and out of daylight saving time on the incidence of such injuries. This is a retrospective comparative observational study of 11-year of data submitted prospectively to the Trauma Audit Research Network (TARN) between 1996 and 2006. Data for 4 weeks before and after time transition in spring and autumn of each year was collected. The time periods selected reflect those hours with maximum light level changes due to time alterations (2-hour around sunrise and 4-hour around sunset). Travellers outside those hours are unlikely to be affected by the changes.Introduction
Method
Functional ultrasound Elastography (FUSE) of Tendo Achilles is an ultrasound technique utilising controlled, measurable movement of the foot to non-invasively evaluate TA elastic and load-deformation properties. The study purpose is to assess Achilles tendons, paratenon and bursa mechanical properties in healthy volunteers and establish an outcome tool for TA treatment. Forty asymptomatic Achilles tendons of 20 healthy volunteers were recruited (10 men and 10 women, age range 18-55). One patient with Acute Achilles rupture scanned to evaluate the tendon gap. Each volunteer answered the Foot and Ankle Outcome Score (FAOS) and Victorian Institute Sport Assessment score (VISA-A) questionnaires. The Achilles Tendons were divided into three thirds (total 120 Proximal, middle and distal thirds). Three longitudinal images of each third were obtained using portable US scan device (Z.one, Zonare Medical System Inc., USA, 8.5 MHz). Images processing was achieved using a MatLAb software (developed by the research team) in parallel Oxford university computers. Each 1/3rd Achilles tendon under went the following scans:
Free hand US scan Free hand Compression decompression Elastography scan Dorsal Flexion elastography Planter flexion elastography Zonare real-time Elastography Elastography scan with the Oxford isometric dynamic foot and Ankle mover (OIDFA) B mode and elasticity images were derived from the raw ultrasound radio frequency data. The anatomical structures mechanical properties were evaluated by a quantitative score of different colours representing stiff tissue (blue) to more soft tissue (green, yellow, red).Purpose
Methods
We compared cancellation rates with two different systems for operating booking. During 9 months of ‘Full Booking’ we gave each patient in the Outpatient Clinic an operating date. After a transition period, we then tried ‘Partial Booking’ (putting each patient on the waiting list and only giving dates after a Consultant-delivered Pre-Assessment Clinic (PAC) review at least 6 weeks before their target operating date.) This was one Consultant's firm, with Day Cases and urgent cases excluded, and a waiting time of nine months. Cancellations were defined as an operating date given that was not honoured. Cancellations due to bed crises were excluded. During the Full Booking phase there was a cancellation rate of 55%, with 64 cancellations out of a potential 116 operating slots. Of these: 29% condition improved, 22% date inconvenient, 19% unwell, 5% gone elsewhere/Private, 9% were moved due to Consultant leave dates, 3% Did Not Attend, and 12.5% date brought forward to fill a cancellation slot. During the Partial Booking phase, 23% of patients attending the PAC were removed from the waiting list without ever being given operating dates. (17 of 132 did not want the operation, 7 Did Not Attend, 6 were unfit). Of the 94 patients given dates, only 8 cancelled (8%). Four subsequently decided against surgery, and four had tests that suggested surgery would not be helpful. The improved efficiency could be due to PAC changes: Consultant presence, having six weeks to act on test results, and dates being agreed only after ‘passing’ PAC. Partial Booking had other benefits, with fewer queries, better informed consent and the optimum time to plan teaching lists, order kit and improve patients' fitness. The Government is still committed to Full Booking. Our cancellation rate improved from 55% to 8% when changing from Full Booking to Partial Booking.
