Investigator-Driven Clinical Trials (IDCT) form a key part of patient-oriented clinical research, the basis for continually improving patient care. Such research is under strain in Europe for a multiplicity of reasons, and because of this the European Medical Research Councils (EMRC) of the ESF has undertaken in 2007 a Forward Look exercise. This Forward Look represents what is probably the most comprehensive examination of IDCT in Europe in recent years. A thorough analysis of the problems faced by academic investigators conducting IDCT was carried out through a series of workshops covering different themes and attended by active and acknowledged experts in the field. These workshops identified specific issues that need to be addressed:. - Categories and Design of Investigator-Driven Clinical Trials. - Regulatory and Legal Issues, Intellectual Property Rights and Data Sharing. - Management of Investigator-Driven Clinical Trials. - Education, Training, Career Tracks and Authorship. - Funding and Models of Partnership. - Status of Investigator-Driven Clinical Trials in Central and Eastern European Countries. A range of possible solutions were proposed and five among the 26 recommendations as ranked by the consensus conference, held on 29–30 September 2008, were considered as top priorities to strengthen IDCT in Europe:. To improve the education, training and career structure for scientists involved in patient-oriented clinical research. To increase levels of funding for IDCT. To adopt a ‘risk-based’ approach to the regulation of IDCT. To streamline procedures for obtaining authorisation for IDCT. To ensure that IDCT are carried out with an appropriate number of patients to produce statistically reliable results – that the trials are ‘correctly powered’. To help implement the recommendations expressed in the report for strengthening patient oriented research in Europe a broad dissemination to the four stakeholder groups identified as key players will be assured.We clearly think that if we can collaborate on this important issue and improve conditions for clinical research, we can contribute to bringing better health and prosperity to Europe

Intra-articular injection is a common way to deliver biologics to joints, but their effectiveness is limited by rapid clearance from the joint space. This barrier can be overcome by genetically modifying cells within the joint such that they produce anti-arthritic gene products endogenously, thereby achieving sustained, therapeutic, intra-articular concentrations of the transgene products without re-dosing. A variety of non-viral and viral vectors have been subjected to preclinical testing to evaluate their suitability for delivering genes to joints. The first transfer of a gene to a human joint used an ex vivo protocol involving retrovirally transduced, autologous, synovial fibroblasts. Recent advances in vector technology allow in vivo delivery using adeno-associated virus (AAV). We have developed an AAV vector encoding the interleukin-1 receptor antagonist (AAV.IL-1Ra) for injection into joints with osteoarthritis (OA). It showed efficacy and safety in equine and rat models of OA, leading to a recently-completed, investigator-initiated, Phase I, dose-escalation clinical trial in 9 subjects with mid-stage OA of the knee (ClinicalTrials.gov Identifier: NCT02790723). Three cohorts of three subjects with mild to moderate OA in the index knee were injected intra-articularly under ultrasound guidance with a low (10e11 viral genomes) medium (10e12 viral genomes) or high (10e13 viral genomes) dose of AAV.IL-1Ra and followed for one year. The data confirm safety, with evidence of sustained intra-articular expression of IL-1Ra and a clinical response in certain subjects. Funding for a subsequent Phase Ib trial involving 50 subjects (ClinicalTrials.gov Identifier: NCT05835895), expected to start later this year, has been acquired. Progress in this area has stimulated commercial activity and there are now at least seven different companies developing gene therapies for OA and a number of clinical trials are in progress.

Acknowledgement: Clinical trial funded by US Department of Defense Clinical Trial Award W81XWH-16-1-0540.

We have undertaken a series of clinical trials over the last 20 years to look at different bearing surface combinations in young adults. We continue to follow these patients well beyond the planned duration of the trials and new information is constantly becoming available. The first trial compared ceramic-on-ceramic with ceramic-on-standard-polyethylene. These patients have now been followed for 20 years with significant wear in the polyethylene group but virtually identical revision rates. The second trial ceramic-on-ceramic, cobalt-chrome-on-standard-polyethylene and cobalt-chrome-on-cross-linked-polyethylene. In this group the ceramic-on-ceramic patients have the lowest revision rate; the ceramic-on-polyethylene group demonstrates a lower wear rate than cobalt-chrome-on-polyethylene. The third trial looks at cobalt-chrome versus zirconium on either cross-linked polyethylene or conventional polyethylene. At 10 years there remains no evidence of improved performance from the zirconium surface as compared to cobalt-chrome. The cross-linked polyethylene group is clearly outperforming the conventional polyethylene in terms of wear rate but at 10 years the revision rates remain the same in all groups. Cross liked polyethylene appears to be the major determining factor in prosthetic longevity and appears to be more important than the counter face material.

Aim

Although non-unions being one of the most common complication after long-bone fracture fixation, the definition of this entity remains controversial and varies widely among authors. A clear definition is crucial, not only for the evaluation of published research data but also for the establishment of uniform treatment concepts. The aim of this systematic review was to identify the definitions and different criteria used in the scientific literature to describe non-unions after long bone fractures.

Mesenchymal Stromal Cells (MSC) have been proposed as a potential therapy for a broad range of diseases including those affecting the musculoskeletal system. MSCs have received market authorization for treatment of graft versus host disease and fistulizing Crohn's disease. In addition, there are clinical trials underway for diseases affecting all organ systems. GMP manufactured cells are required for these clinical trials and suitable facilities with regulatory approval are thus crucial for the translational process. In this presentation I will review the process whereby such a facility has been constructed at NUI Galway and discuss challenges in operations and sustainability. Researchers at REMEDI and spin out company Orbsen Therapeutics are currently involved in 7 clinical trials using MSCs, 4 of which are EU wide consortia funded by the EU Commission. The presentation will also discuss issues such as source of MSCs, cell sorting, use of bioreactors and xeno-free processes.

Shoulder impingement is one of the most common non-traumatic upper limb causes of disability in adults. Often resulting in pain and disability, management remains highly debated. This meta-analysis of randomized trials aims to evaluate the efficacy of surgical intervention in the setting of shoulder impingement in comparison to non-operative or sham treatments.

Two reviewers independently screened MEDLINE, EMBASE, PUBMED and Cochrane databases for randomized control trials published from 1946 through to May 19th, 2018. A risk of bias assessment was conducted for all included studies and outcomes were pooled using a random effects model. The primary outcome was improvement in pain up to two years. Secondary outcomes included functional outcome scores reported at the short term (/=2 years). Heterogeneity was assessed using the I2statistic. Functional outcome scores were presented along with minimal clinically important differences to provide clinical context to findings.

Twelve RCT's (n=1062 patients) were included in this review. Eligible patients were a mean age of 48 (SD +/− 4) years with 45% being male gender. The pooled treatment effect of surgical intervention for shoulder impingement did not demonstrate any benefit to surgery with respect to pain relief (mean difference [MD] −0.07, 95% CI −0.40 to 0.26) or short-term functional outcomes (standardized mean difference [SMD] −0.09, 95% confidence interval [CI] −0.27 to 0.08). Surgical intervention did result in a small statistically significant but clinically unimportant improvement in long term functional outcomes (SMD 0.23, 95% CI 0.06 to 0.41).

Evidence suggests surgical intervention has little, if any, benefit for impingement pathology in the middle-aged patient.

Background & purpose

Measurement inconsistency across clinical trials is tackled by the development of a core outcome measurement set. Four core outcome domains were recommended for clinical trials in patients with non-specific LBP (nsLBP): physical functioning, pain intensity, health-related quality of life (HRQoL), and number of deaths. This study aimed to reach consensus on core instruments to measure the first three domains.

Lower limb fractures are commonly treated with cast immobilization, and as a main consequence of strict immobilization this typically leads to loss in muscle mass, decrease of bone density and decline in functional abilities. Body-worn sensors are increasingly used to assess outcome in clinical trials by providing objective mobility parameters in a real-world environment. The aim of this study is to investigate the usability aspects and potential changes in mobility parameters in partial-immobilization patients in real-world conditions. Six healthy young males (age 22.2 ± 1.2 years; weight 76.5 ± 6.7 kg, height 185.8 ± 6.1 cm. Mean ± standard deviation) wore a leg cylinder cast with walker boot to immobilize their dominant leg for two consecutive weeks. Subjects were asked to continuously wear a tri-axial accelerometer on the waist (actibelt) during waking hours for 6 weeks including 2 weeks before, during and after cast immobilisation. The total amount of days of continuous recording was 339 days with a total wearing time of 120 days. Software packages which allow to detect steps and to estimate real-world walking speed were used to analyse the accelerometry data. It was suspected that knee immobilization would affect strongly the wave form of the signal with an impact on the accuracy of the speed algorithm, whereas the step detection should be more robust. This effect was confirmed in a preliminary study performed to quantify the accuracy under immobilization conditions. On the other hand, step numbers are known to be sensitive to fluctuations in wearing time which was not uniform throughout the entire study. We concluded that in this setting step frequency is the most reliable parameter. Step frequency showed a systematic decrease in the values during the immobilization period which recovered to pre-immobilisation values after cast removal. This confirms the usability of accelerometry and sensitivity of its mobility parameters for clinical outcome assessment.

Aims. This systematic review places a recently completed multicentre randomized controlled trial (RCT), UK FROST, in the context of existing randomized evidence for the management of primary frozen shoulder. UK FROST compared the effectiveness of pre-specified physiotherapy techniques with a steroid injection (PTSI), manipulation under anaesthesia (MUA) with a steroid injection, and arthroscopic capsular release (ACR). This review updates a 2012 review focusing on the effectiveness of MUA, ACR, hydrodilatation, and PTSI. Methods. MEDLINE, Embase, PEDro, Science Citation Index, Clinicaltrials.gov, CENTRAL, and the World Health Organization (WHO) International Clinical Trials Registry were searched up to December 2018. Reference lists of included studies were screened. No language restrictions applied. Eligible studies were RCTs comparing the effectiveness of MUA, ACR, PTSI, and hydrodilatation against each other, or supportive care or no treatment, for the management of primary frozen shoulder. Results. Nine RCTs were included. The primary outcome of patient-reported shoulder function at long-term follow-up (> 6 months and ≤ 12 months) was reported for five treatment comparisons across four studies. Standardized mean differences (SMD) were: ACR versus MUA: 0.21 (95% confidence interval (CI) 0.00 to 0.42), ACR versus supportive care: -0.13 (95% CI -1.10 to 0.83), and ACR versus PTSI: 0.33 (95% CI 0.07 to 0.59) and 0.25 (95% CI -0.34 to 0.85), all favouring ACR; MUA versus supportive care: 0 (95% CI -0.44 to 0.44) not favouring either; and MUA versus PTSI: 0.12 (95% CI -0.14 to 0.37) favouring MUA. None of these differences met the threshold of clinical significance agreed for the UK FROST and most confidence intervals included zero. Conclusion. The findings from a recent multicentre RCT provided the strongest evidence that, when compared with each other, neither PTSI, MUA, nor ACR are clinically superior. Evidence from smaller RCTs did not change this conclusion. The effectiveness of hydrodilatation based on four RCTs was inconclusive and there remains an evidence gap. Cite this article: Bone Jt Open 2021;2(9):773–784

Randomised controlled clinical trials (RCTs) produce the most reliable evidence about the effects of clinical care. In surgical trials, lack of surgeons’ individual equipoise (state of genuine uncertainty about treatment arms) appears to be one of the greatest obstacles. Collective equipoise based on present or imminent controversy in the expert medical community has been proposed as a solution (Freedman, 1987), but could be applied only at the beginning of a trial to a general trial question.

We developed a system that quantifies collective uncertainty among a group of surgeons for an individual clinical case. After a successful pilot study the system was introduced as an independent project within the UK Heel Fracture Trial. The expert panel included 10 surgeons from 8 hospitals. Anonymous clinical data of potentially eligible consecutive cases including CT and X-ray images was published on a secure online forum after 6 weeks follow up clinic to avoid interference with clinical course. Surgeons registered in the panel estimated the probability that the patient would be better or worse by various degrees with operative treatment.

30 clinical cases have been analysed, including 6 bilateral fractures (otherwise excluded). 86.7% could be recommended for inclusion in the trial, compared to 43.3% recruited out of this series in the actual trial. Lack of individual uncertainty within the panel was present in every case.

The system not only has a potential to improve recruitment in surgical RCTs, but provides ethically sound grounds to offer or otherwise a patient participation in a trial. Surgeon’s individual equipoise dilemma and responsibility is shared with colleagues. Cases that otherwise will be excluded can be evaluated with broader inclusion criteria. The system is easy to use, cheap and reliable. Limitations include surgeons’ compliance and time lapse (at least 48 hours) for voting to be completed.

Background and purpose:

Inconsistent outcome reporting is a problematic issue in systematic reviews of clinical trials in non-specific LBP (NSLBP). To facilitate statistical pooling and improve reliability of reviews, the development of a core outcome set (COS) is recommended. In 1998, Deyo et al. proposed a standardized set of domains and measurement instruments for LBP clinical research. An international steering committee (ISC) was formed to update 1998 recommendations, and to determine, at first, which outcome domains should be included in a COS for clinical trials in NSLBP.

The Acrobot®, an active constraint “hands-on” robotic system, gives navigation cues to the surgeon, and also assists him in the surgery, using active software constraints if he tries to depart from the preoperative plan. It has just entered clinical trials. We report the first 5 cases.

The Acrobot® system for precision total knee arthroplasty comprises the following components:

1. A CT-based planning system

a gross positioning device with separate brakes and encoders, locked off for safety during the procedure,

4. The Acrobot’s software which:

imports the preoperative plan,

Each patient’s knee scores were monitored and postoperative CT scan was compared with the preoperative plan.

Seven robot assisted arthroplasties have been performed. No significant complications have been encountered. The Knee and Womac Scores show that the procedure is safe and comparable to conventional surgery in the early postoperative period. The envelope of error on postoperative CT scans has been within the accuracy of the method of measurement, at < 1 mm and < 10 without the outliers which haunt every clinical series.

The Acrobot® system for total knee arthroplasty has completed its preliminary trial satisfactorily. It provides a handson operation but with robotic levels of accuracy. It is suitable for conventional open surgery, but its real place will be in the arena of minimally invasive unicondylar knee arthroplasty, hip arthroplasty and resurfacing, and in the spine, where active constraint will prevent potentially dangerous surgical errors.

Purpose

Clinical trials for common health conditions are constantly being designed and implemented in our institution, often with some urgency to meet funding deadlines. The scope and complexity of these trials has resulted in the need for databased computer management systems typically tailored to each project. Even with current advanced software resources, development, testing and implementation can take months for each new project. This presentation describes a new approach to this problem involving an adaptive table-driven software system using project-specific recruitment and screening data which we have developed using visual basic.

Background: Hip fracture trials have employed a wide range of patient-reported outcomes (PRO) suggesting a lack of consensus among clinicians on what are considered the most relevant outcomes. Variability in functional outcome reporting in hip fracture management creates challenges in the comparison of results across trials. The purpose of this study was to conduct a systematic review of the functional outcomes fielded in randomized controlled trials in post-operative hip fracture treatment for the aged. We hypothesized that over time there had been an increase in patient-reported outcomes along with aggregate scoring systems of hip function.

Methods: An electronic database search was conducted using key terms combining: ‘hip fracture’ with ‘RCT’ with ‘age 65 years and over’. s and titles were screened in duplicate and independently. All of the articles that met eligibility criteria were reviewed using the 21-point Detsky Quality Assessment Scale.

Results: In 2451 citations, 86 studies were included and also met accepted standards of inter-observer reliability (kappa, 0.92; 95% confidence interval, 0.87 to 0.98). The mean score (and standard error) for the quality of the randomized trials was: 75.8% ± 1.76% (95% confidence interval, 72.3%–79.3%) and 27 (32.6%) of the trials scored < 75%. Medical trials had a higher mean quality score than did surgical trials (83.7% compared with 72.7 %, p = 0.025). 59 trials (30 Surgical, 11 medical and 18 rehabilitation trials) scored > 75% in quality. Out of 86 trials, 8 (13.6%) used EQ-5D for utility and 6 (10.1%) used the SF-36 health status measures. At most, 12 trials used the same composite score: 12 (13.9%) ADL Katz Index, 9 (10.4%) trials used the HHS and 8 (9.3%) trials used Parker’s mobility score.

Conclusion: Although in the past decade more studies have made use of outcome instruments that capture both impairment and functional status in one aggregate score, there is a lack of standardized assessment.

Purpose

Displaced midshaft clavicular fractures are a common injury with a high occurrence rate in young, active individuals. Non-operative care has traditionally been the standard of care for such fractures, but more recent studies have suggested benefits following primary operative fixation. The purpose of this study was to review the literature on displaced midshaft clavicle fractures, identify randomized controlled trials of operative versus non-operative treatment, and pool the functional outcome and complication rates (including nonunion and symptomatic malunion), to arrive at summary estimates of these outcomes.

Objectives: To assess the evidence for a similar pattern of response to treatment among non-specific low back pain (NSLBP) patients in clinical trials.

Design: A systematic review of published trials on NSLBP and meta-analysis of within-group treatment effect calculated as the Standardised Mean Difference (SMD).

Data source: The Cochrane Register of Controlled Trials’ database (CENTRAL), April 2007.

Review methods: We included randomised controlled trials that investigated the effectiveness of primary care treatments in patients with NSLBP aged 18 years or over. We excluded trials conducted in patients with LBP of identifiable cause (e.g. disc herniation or arthritis), post-operative or post-traumatic back pain, or back pain during pregnancy or labour. We chose outcome measures commonly used in the majority of NSLBP trials, namely the Visual Analogue scale (VAS) for pain severity, Roland Morris Disability questionnaire (RMDQ) and Oswestry Disability questionnaire (ODQ) for physical functioning.

Results: 118 trials investigating a wide range of primary care treatment for NSLBP were included. In spite of heterogeneity, we found evidence for a similar pattern of symptom improvement represented by large SMDs at six weeks follow up ((0.86 for pain, 95% CI = 0.65,1.07, 0.97 for RMDQ, 95% CI = 0.66,1.28 and 0.98 for ODQ, 95% CI = 0.62,1.33) followed by much smaller further change at 13 week (pain 1.07 95% CI = 0.87,1.27, RMDQ 0.93 95% CI = 0.67,1.20, ODQ 0.92 95% CI = 0.70,1.14), 27 week (pain 1.03 95% CI = 0.82,1.25, RMDQ 0.91 95% CI = 0.59,1.24, ODQ 1.08 95% CI = 0.80,1.36 and 52 week (pain 0.88 95% CI = 0.60,1.1, RMDQ 1.01 95% CI = 0.68,1.34, ODQ 1.14 95% CI = 0.88,1.39). There was no statistically significant difference between responses in various trials arms (index treatment, active comparator treatment, placebo or sham treatment, usual care or waiting list controls). There was also no statistically significant difference between responses to pharmacological and non-pharmacological treatments.

Conclusions: NSLBP symptoms seem to improve very well and in a similar pattern in clinical trials following a wide variety of active as well as inactive treatments. It is important to explore factors other than the treatments themselves that might influence symptom improvement. Exploring possible sources of underlying heterogeneity in responses might lead to some of these factors.

Conflict of Interest: None

Source of Funding: This work is part of a PhD fellowship funded by the arc (Arthritis research campaign).

Background: The literature on hip fractures is increasingly reporting patient-reported outcomes along with aggregate scoring systems. However, this rapid growth in the number and types of patient-based outcomes can be confusing. The purpose of this paper is to conduct a systematic review of the functional outcome instruments fielded in high quality randomized clinical trials evaluating postoperative hip fracture management and rehabilitation in the aged.

Methods: An electronic database search was conducted using a variety of key terms combining: ‘hip fracture’ with ‘RCT’ with ‘age 65 years and over’. Abstracts and titles were screened in duplicate and independently. Studies were eligible based on the following criteria: hip fracture, randomized controlled trial, mean age of 65 years, and in the English language. Studies were excluded based on the following criteria: inclusion of fractures other than hip, minimum age of patient enrolment < 50 years old and prevention or fracture risk reduction as primary outcome of study. All of the articles that met eligibility criteria were reviewed using the Detsky Quality Assessment Scale.

Results: In 2451 citations, 86 studies were included and also met accepted standards of inter-observer reliability (kappa, 0.92; 95% confidence interval, 0.87 to 0.98). Discordance was resolved by consensus. The mean score (and standard error) for the quality of the randomized trials was: 75.8% ± 1.76% (95% confidence interval, 72.3%–79.3%) and 27 (32.6%) of the trials scored < 75%. Medical trials had a higher mean quality score than did surgical trials (83.7% compared with 72.7 %, p = 0.025). Data was abstracted from the 59 trials (30 Surgical, 11 medical and 18 rehabilitation trials) scoring > 75% in quality. Surgical trials had 16.7% more measures of disability than measures of impairment. Furthermore, 70% of the surgical trials used composite scores when compared to either medical or rehabilitation trials. Eight trials (13.6%) used EQ-5D for utility and 6 (10.1%) used the SF-36 health status measures. At most, 10 trials used the same composite score: 10 (16,9%) ADL Katz Index, 9 (15.2%) trials used the Harris hip score and 5 (8.5%) trials used Parker’s mobility score.

Discussion/Conclusion: Although there is a trend towards studies assessing functional recovery as a primary outcome in the aged with hip fractures, none of the measures were used consistently. A lack of standardized assessment in these groups of patients will overestimate treatment effects.

Background: There is no consensus on the surgical management of unstable distal radius fractures. In this systematic review and meta-analysis, we pool data from trials comparing external fixation and internal fixation for treatment of this injury.

Methods: We searched electronic databases and conference proceedings for published and unpublished trials. Two authors independently screened titles and s, reviewed manuscripts, graded methodological quality, and extracted all relevant information from eligible studies. Data were pooled using fixed-effects and random-effects models with standard mean differences (SMD) and risk ratios for continuous and dichotomous variables, respectively. Heterogeneity across studies was assessed with Forest plots and calculation of the I2 statistic. Subgroup analyses were defined a priori and performed where appropriate.

Results: We pooled data from nine comparative trials, totaling 750 patients (360 fractures treated with external fixation and 397 with internal fixation). Initially, we found substantial heterogeneity between studies and no significant difference according to our primary outcome measure, validated patient-reported outcomes (SMD=0.20, 95% confidence interval=[−0.12, 0.51], p=0.22, I2=65%). However, when we grouped studies by plate type, we eliminated heterogeneity within each subgroup and found locking volar plates demonstrated significantly better patient-reported outcomes compared to external fixation (SMD=1.30, 95% CI=[0.74, 1.86], p< 0.00001, I2=0%). Additionally, we found internal fixation yielded significantly better recovery of forearm supination and restoration of volar tilt (SMD=0.31, 95% CI=[0.15, 0.47], p=0.0002, I2=0; SMD=0.57, 95% CI=[0.57, 0.78], p< 0.00001, I2=0, respectively). Subgroup analyses showed external fixation yielded better wrist flexion among randomized studies (SMD= 0.43, p< 0.003, 95% CI=[ 0.67, 0.20], I2=0), and there was no significant difference in grip strength among studies with high methodological quality (SMD= 0.08, 95% CI=[−0.34, 0.18], p=0.54, I2=0%).

Conclusions: Open reduction and internal fixation of unstable distal radius fractures yields greater recovery of forearm supination, better restoration of anatomic volar tilt, and, for locking volar plates in particular, superior patient-reported function. External fixation may result in better wrist flexion, but no difference exists in terms of grip strength.

Improvement in survival for teenagers and young adults (TYAs) has lagged behind those of children and adults, (Stiller et al 2006). In seeking explanations investigators have focused on two main factors. Firstly, the low accrual of TYAs into clinical trials (Newburger et al, 2002), and secondly the lack of appropriate multidisciplinary care (Stevens, 2005).

Data from the UK Office of National Statistics confirms this with 70% of paediatric patients being entered into a clinical trial compared to only 20% of 15–24 year olds. In 2007 the Teenage Cancer Trust (TCT) asked over 200 14–25 year olds with cancer if they had been offered a clinical trial (TCT survey results, 2008). Of the total cohort only 30% reported that they had been given the opportunity to enter a clinical trial. The National Cancer Research Institute (NCRI) established a Teenage and Young Adult Clinical Studies Development Group in 2005 to address the issues surrounding the accrual of TYAs into clinical trials.

At a specialist Teenage Cancer Trust Unit in the UK a TYA Clinical Research Nurse was appointed in May 2008; in order to improve TYA accrual into clinical trials. An audit is currently been undertaken to examine present data of clinical trial entry and retrospective data from 2006 and 2007. The focus of the audit is on patients aged 16–24 years with a bone or soft tissue sarcoma being treated in one TCT unit in the UK.

The audit will examine whether the appointment of a TYA research nurse has influenced the accrual of TYA patients into clinical trials. The paper will focus on the particular difficulties and challenges with recruiting TYA patients and the developing role of the TYA Research Nurse in influencing practice. It is essential that improvements are made with regard to trial entry for this unique age group and the TYA Research Nurse may play a vital role in this in the future.

Introduction

While there is a desperate need for effective treatments for acute spinal cord injury (SCI), the clinical validation of novel therapeutic interventions is severely hampered by the need to recruit relatively large numbers of patients into clinical trials for sufficient statistical power. While a centre might annually admit 100 acute SCI patients, only a fraction may satisfy the basic inclusion criteria for an acute clinical trial, which typically requires patients of a certain injury severity (eg ASIA A), within a specific time window (eg. 12 hours from injury), and without other major injuries or conditions that would cloud the baseline neurologic assessment. This study was conducted to define that “fraction” of SCI patients that would theoretically satisfy standard inclusion criteria of an acute clinical trial.