RESUMO
STUDY DESIGN: Questionnaire survey. OBJECTIVES: Although a range of novel therapeutic approaches for traumatic spinal cord injury (tSCI) are being trialled in highly standardised, pre-clinical research models, little has been published about the extent of standardisation in health service delivery for newly injured tSCI patients. SETTING: All Emergency Medical Services (EMSs) and 11 level-1 trauma centres (L1TCs) in the Netherlands. METHODS: A survey assessing the organisation of pre-hospital and acute tSCI management was developed and distributed across all 23 pre-hospital EMSs and 11 L1TCs based in the Netherlands. RESULTS: Response rates for EMSs and L1TCs were 82 and 100%, respectively. Thirteen EMSs (68%) transported all patients who are suspected of having tSCI to L1TCs. The decision to transfer tSCI patients to L1TCs was primarily made by paramedics at the scene of accident (79%). Nonetheless, no EMS reported the use of validated neurological assessments for determining the likelihood of tSCI. The International Standards for Neurological Classification of SCI were used to determine the level and severity of tSCI in four centres, and three centres performed magnetic resonance imaging in all tSCI patients. Three L1TCs had spinal cord perfusion support protocols in place, and two centres administered methylprednisolon to acute tSCI patients. CONCLUSION: We found a large variance in the delivery of pre-hospital and acute tSCI management in a well-defined geographical catchment area. This survey urges the need for implementing standardised assessments and developing best-practice guidelines, which should be endorsed by all pre-hospital and acute tSCI health-care providers.
Assuntos
Gerenciamento Clínico , Serviço Hospitalar de Emergência/normas , Traumatismos da Medula Espinal/diagnóstico , Traumatismos da Medula Espinal/terapia , Área Programática de Saúde/estatística & dados numéricos , Protocolos Clínicos/normas , Feminino , Seguimentos , Inquéritos Epidemiológicos , Humanos , Modelos Logísticos , Masculino , Países Baixos , Traumatismos da Medula Espinal/epidemiologia , Inquéritos e Questionários , Centros de Traumatologia/estatística & dados numéricosRESUMO
STUDY DESIGN: This is a mixed-method consensus development project. OBJECTIVES: The objective of this study was to identify a top ten list of priorities for future research into spinal cord injury (SCI). SETTING: The British Spinal Cord Injury Priority Setting Partnership was established in 2013 and completed in 2014. Stakeholders included consumer organisations, healthcare professional societies and caregivers. METHODS: This partnership involved the following four key stages: (i) gathering of research questions, (ii) checking of existing research evidence, (iii) interim prioritisation and (iv) a final consensus meeting to reach agreement on the top ten research priorities. Adult individuals with spinal cord dysfunction because of trauma or non-traumatic causes, including transverse myelitis, and individuals with a cauda equina syndrome (henceforth grouped and referred to as SCI) were invited to participate in this priority setting partnership. RESULTS: We collected 784 questions from 403 survey respondents (290 individuals with SCI), which, after merging duplicate questions and checking systematic reviews for evidence, were reduced to 109 unique unanswered research questions. A total of 293 people (211 individuals with SCI) participated in the interim prioritisation process, leading to the identification of 25 priorities. At a final consensus meeting, a representative group of individuals with SCI, caregivers and health professionals agreed on their top ten research priorities. CONCLUSION: Following a comprehensive, rigorous and inclusive process, with participation from individuals with SCI, caregivers and health professionals, the SCI research agenda has been defined by people to whom it matters most and should inform the scope and future activities of funders and researchers for the years to come. SPONSORSHIP: The NIHR Oxford Biomedical Research Centre provided core funding for this project.
Assuntos
Pesquisa Biomédica , Comportamento Cooperativo , Prioridades em Saúde , Traumatismos da Medula Espinal , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Pesquisa Biomédica/organização & administração , Cuidadores/psicologia , Consenso , Feminino , Pessoal de Saúde/psicologia , Humanos , Masculino , Pessoa de Meia-Idade , Traumatismos da Medula Espinal/diagnóstico , Traumatismos da Medula Espinal/psicologia , Traumatismos da Medula Espinal/terapia , Reino Unido , Adulto JovemRESUMO
STUDY DESIGN: A longitudinal, prospective, self-controlled cohort study. OBJECTIVES: To determine (1) the preliminary benefits of using eye-tracking computer systems (ETCSs) among inpatients with tetraplegia and (2) the feasibility of carrying out a well-powered randomized controlled trial. SETTING: Specialist Spinal Cord Injuries Centre, United Kingdom; 6 months during 2013-2014. METHODS: Individuals with tetraplegia who were admitted to the center and enrolled in this study were trained and allowed to use the ETCS (Tobii Eyegaze C15 System) twice a week for a duration of 10 weeks. Standardized training modules were developed and offered to all study participants. Study feasibility indicators as well as the Appraisals of Disability: Primary and Secondary Scale, Hospital Anxiety and Depression Scale and the Assistive Technology Device Predisposition Assessment questionnaire scores were taken before and after study enrollment. RESULTS: A total of 31 inpatients with tetraplegia were screened. Although 14 patients (45%) met the study eligibility criteria, 6 patients (19%) consented to be enrolled in the study. Three participants did not complete the planned training schedule because of medical, technical and logistic reasons. Although half of the participants agreed that the ETCS under study was easy to use, no substantial improvements were seen in terms of psychological outcomes, appraisals of disability or independence. CONCLUSIONS: The conduct of a controlled trial evaluating the benefits of using ETCSs among newly injured patients with tetraplegia comes with considerable feasibility challenges. Until substantial technical improvements of ETCSs have been implemented, future research should initially focus on those individuals with tetraplegia who are living in the community and who have expressed a need to enhance their computer access and communication skills.
RESUMO
PURPOSE: To compare the clinical features of patients with sacroiliac joint (SIJ)-related sciatica-like symptoms to those with sciatica from nerve root compression and to investigate the necessity to perform radiological imaging in patients with sciatica-like symptoms derived from the SIJ. METHODS: Patients with pain radiating below the buttocks with a duration of 4 weeks to 1 year were included. After physical and radiological examinations, a diagnosis of SI joint-related pain, pain due to disk herniation, or a combination of these two causes was made. RESULTS: Patients with SIJ-related leg pain (n = 77/186) were significantly more often female, had shorter statue, a shorter duration of symptoms, and had more often pain radiating to the groin and a history of a fall on the buttocks. Muscle weakness, corkscrew phenomenon, finger-floor distance ≥25 cm, lumbar scoliosis, positive Bragard or Kemp sign, and positive leg raising test were more often present when radiologic nerve root compression was present. Although these investigations may help, MRI of the spine is necessary to discriminate between the groups. CONCLUSIONS: Sciatica-like symptoms derived from the SIJ can clinically mimic a radiculopathy. We suggest to perform a thorough physical examination of the spine, SI joints, and hips with additional radiological tests to exclude other causes.
Assuntos
Radiculopatia/diagnóstico , Articulação Sacroilíaca/patologia , Ciática/etiologia , Diagnóstico Diferencial , Feminino , Humanos , Masculino , Radiculopatia/complicaçõesRESUMO
OBJECTIVES: Despite many years of research, there is currently no treatment available that results in major neurological or functional recovery after traumatic spinal cord injury (tSCI). In particular, no conclusive data related to the role of the timing of decompressive surgery, and the impact of injury severity on its benefit, have been published to date. This paper presents a protocol that was designed to examine the hypothesized association between the timing of surgical decompression and the extent of neurological recovery in tSCI patients. STUDY DESIGN: The SCI-POEM study is a Prospective, Observational European Multicenter comparative cohort study. This study compares acute (<12 h) versus non-acute (>12 h, <2 weeks) decompressive surgery in patients with a traumatic spinal column injury and concomitant spinal cord injury. The sample size calculation was based on a representative European patient cohort of 492 tSCI patients. During a 4-year period, 300 patients will need to be enrolled from 10 trauma centers across Europe. The primary endpoint is lower-extremity motor score as assessed according to the 'International standards for neurological classification of SCI' at 12 months after injury. Secondary endpoints include motor, sensory, imaging and functional outcomes at 3, 6 and 12 months after injury. CONCLUSION: In order to minimize bias and reduce the impact of confounders, special attention is paid to key methodological principles in this study protocol. A significant difference in safety and/or efficacy endpoints will provide meaningful information to clinicians, as this would confirm the hypothesis that rapid referral to and treatment in specialized centers result in important improvements in tSCI patients.
Assuntos
Descompressão Cirúrgica/métodos , Seleção de Pacientes , Traumatismos da Medula Espinal/epidemiologia , Traumatismos da Medula Espinal/cirurgia , Estudos de Coortes , Europa (Continente)/epidemiologia , Seguimentos , Humanos , Estudos Prospectivos , Recuperação de Função Fisiológica/fisiologia , Fatores de Tempo , Resultado do TratamentoRESUMO
STUDY DESIGN: Prospective multicenter cohort study. OBJECTIVES: To compare the neurological recovery and functional outcomes between traumatic central cord syndrome (TCCS) patients and motor incomplete tetraplegic patients. SETTING: European Multicenter Study of human spinal cord injury. METHODS: In 248 traumatic motor incomplete tetraplegics, initial phase (0-15 days) American Spinal Injury Association (ASIA) impairment grading, upper and lower extremity motor scores (UEMS and LEMS), upper and lower sensory scores and chronic phase (6 or 12 months) neurological outcomes were analyzed. In addition, chronic phase self-care and indoor mobility Spinal Cord Independence Measure (SCIM) items were studied. Tetraplegics were subdivided into three groups: (1) non-TCCS group (UEMSî¶LEMS), (2) intermediate-TCCS group (UEMS=(1-9 points)Assuntos
Síndrome Medular Central/diagnóstico
, Síndrome Medular Central/reabilitação
, Vias Eferentes/fisiopatologia
, Quadriplegia/diagnóstico
, Quadriplegia/reabilitação
, Adolescente
, Adulto
, Idoso
, Idoso de 80 Anos ou mais
, Síndrome Medular Central/fisiopatologia
, Estudos de Coortes
, Diagnóstico Diferencial
, Feminino
, Humanos
, Masculino
, Pessoa de Meia-Idade
, Prognóstico
, Estudos Prospectivos
, Quadriplegia/fisiopatologia
, Recuperação de Função Fisiológica/fisiologia
, Resultado do Tratamento
, Adulto Jovem
RESUMO
STUDY DESIGN: Prospective multi-center cohort study. OBJECTIVES: To compare the neurological and functional recovery between tetraplegic Brown-Séquard-plus syndrome (BSPS) and incomplete tetraplegia (non-BSPS). SETTING: European Multicenter Study of Human Spinal Cord Injury (EM-SCI). METHODS: BSPS was defined as a traumatic incomplete spinal cord injury (SCI) with ipsilateral weakness and contralateral loss of pinprick sensation at neurologic levels C2-T1. Acute (0-15 days) and chronic phase (6 or 12 months) were assessed for the American Spinal Injury Association (ASIA) sensory scores, upper extremity motor scores and lower extremity motor scores. Furthermore, chronic phase scores of all Spinal Cord Independence Measure (SCIM) II items were analyzed. Differences in neurological and functional outcome between BSPS patients and non-BSPS patients were calculated using Student's t-tests and Wilcoxon signed rank tests. RESULTS: Out of 148 tetraplegic patients, 30 were diagnosed with BSPS. Patients with an ASIA impairment scale (AIS) B were significantly (P<0.001) more identified in non-BSPS patients (25%) compared with BSPS patients (3%), respectively. After 12 months, the median scores for sphincter management of the bladder for both BSPS and non-BSPS patients were 15. Both 25 and 75% quartile median scores were 15 for BSPS patients and 12 and 15 for non-BSPS patients (P<0.02). Except for the difference in bladder function, no significant differences were identified in other SCIM II subitems and ASIA motor or sensory scores between BSPS and non-BSPS patients when stratified for injury severity by excluding AIS B patients. CONCLUSION: Compared with incomplete tetraplegic patients, patients with cervical BSPS have a similar neurological and functional recovery when matched for the AIS.
Assuntos
Síndrome de Brown-Séquard/fisiopatologia , Avaliação da Deficiência , Recuperação de Função Fisiológica/fisiologia , Traumatismos da Medula Espinal/fisiopatologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Síndrome de Brown-Séquard/diagnóstico , Síndrome de Brown-Séquard/epidemiologia , Estudos de Coortes , Europa (Continente)/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Exame Neurológico/métodos , Avaliação de Resultados em Cuidados de Saúde/métodos , Valor Preditivo dos Testes , Estudos Prospectivos , Índice de Gravidade de Doença , Traumatismos da Medula Espinal/diagnóstico , Traumatismos da Medula Espinal/epidemiologia , Adulto JovemRESUMO
STUDY DESIGN: Systematic review. BACKGROUND: The applied definition of traumatic central cord syndrome (TCCS) lacks specific quantified diagnostic criteria. OBJECTIVE: To review currently applied TCCS diagnostic criteria and quantitative data regarding the 'disproportionate weakness' between the upper and lower extremities described in original studies reporting on TCCS subjects. METHODS: A MEDLINE (1966 to 2008) literature search was conducted. The descriptors applied to define TCCS were extracted from all included articles. We included original studies that reported on the differences in motor score (based on the Medical Research Council scale) between the total upper extremity motor score (UEMS) and the total lower extremity motor score (LEMS), in a minimum of five TCCS patients at the time of hospital admission. The mean difference between the total UEMS and the total LEMS of the patients included in each study was calculated. Case reports were excluded. RESULTS: None of the identified studies on TCCS patients reported inclusion and/or exclusion criteria using a quantified difference between the UEMS and LEMS. Out of 30 retrieved studies, we identified seven different clinical descriptors that have been applied as TCCS diagnostic criteria. Nine studies reporting on a total of 312 TCCS patients were eligible for analysis. The mean total UEMS was 10.5 motor points lower than the mean total LEMS. CONCLUSIONS: There is no consensus on the diagnostic criteria for TCCS. Nevertheless, this review revealed an average of 10 motor points between the UEMS and LEMS as a possible TCCS diagnostic criterion. However, further discussion by an expert panel will be required to establish definitive diagnostic criteria.
Assuntos
Síndrome Medular Central/diagnóstico , Síndrome Medular Central/fisiopatologia , Avaliação da Deficiência , Extremidades/fisiopatologia , Paralisia/diagnóstico , Paralisia/fisiopatologia , Braço/inervação , Braço/fisiopatologia , Síndrome Medular Central/complicações , Diagnóstico Diferencial , Extremidades/inervação , Humanos , Perna (Membro)/inervação , Perna (Membro)/fisiopatologia , Debilidade Muscular/diagnóstico , Debilidade Muscular/etiologia , Debilidade Muscular/fisiopatologia , Paralisia/etiologiaRESUMO
STUDY DESIGN: A questionnaire survey. OBJECTIVES: To evaluate the need for the introduction of quantitative diagnostic criteria for the traumatic central cord syndrome (TCCS). SETTING: An online questionnaire survey with participants from all over the world. METHODS: An invitation to participate in an eight-item online survey questionnaire was sent to surgeon members of AOSpine International. RESULTS: Out of 3340 invited professionals, 157 surgeons (5%) from 41 countries completed the survey. Whereas most of the respondents (75%) described greater impairment of the upper extremities than of the lower extremities in their own TCCS definitions, symptoms such as sensory deficit (39%) and bladder dysfunctions (24%) were reported less frequently. Initially, any difference in motor strength between the upper and lower extremities was considered most frequently (23%) as a 'disproportionate' difference in power. However, after presenting literature review findings, the majority of surgeons (61%) considered a proposed difference of at least 10 points of power (based on the Medical Research Council scale) in favor of the lower extremities as an acceptable cutoff criterion for a diagnosis of TCCS. Most of the participants (40%) felt that applying a single criterion to the diagnosis of TCCS is insufficient for research purposes. CONCLUSION: Various definitions of TCCS were used by physicians involved in the spinal trauma care. The authors consider a difference of at least 10 motor score points between upper and lower extremity power a clear diagnostic criterion. For clinical research purposes, this diagnostic criterion can be considered as a face valid addendum to the commonly applied TCCS definition as introduced by Schneider et al.
Assuntos
Síndrome Medular Central/diagnóstico , Coleta de Dados/normas , Avaliação da Deficiência , Debilidade Muscular/diagnóstico , Paralisia/diagnóstico , Inquéritos e Questionários/normas , Síndrome Medular Central/complicações , Síndrome Medular Central/fisiopatologia , Diagnóstico Diferencial , Humanos , Debilidade Muscular/etiologia , Debilidade Muscular/fisiopatologia , Paralisia/etiologia , Paralisia/fisiopatologiaRESUMO
STUDY DESIGN: Prospective multicenter longitudinal cohort study. OBJECTIVES: To determine the relationship between improvements of the American Spinal Injury Association/International Spinal Cord Society (ASIA/ISCoS) neurological standard scale (AIS) outcome measure and improvements of functional ambulatory outcome measures in patients with traumatic spinal cord injury (SCI). SETTING: European multicenter study of human SCI (EM-SCI). METHODS: In 273 eligible patients with traumatic SCI, acute (0-15 days) and chronic phase (6 or 12 months) AIS grades, timed up and go (TUG) test and 10-m walk test (10MWT) outcome measurements were analyzed. Subanalysis of those patients who did have AIS conversion was performed to assess its relation with functional ambulatory outcomes. RESULTS: Studied population consisted of 161 acute phase AIS grade A patients; 37 grade B; 43 grade C and 32 acute phase AIS grade D patients. Forty-two patients (26%) converted from AIS grade A, 27 (73%) from grade B, 32 (75%) from grade C and five patients (16%) from AIS grade D. The frequencies of AIS conversions and functional ambulation recovery outcomes were significantly different (P<0.001) in patients with motor complete SCI. The ratio of patients with both recovery of ambulatory function and AIS conversion (n=101) differed significantly (P<0.001) between the acute phase AIS grade scores; AIS grade A (6/40 patients, 15%), B (9/27 patients, 33%), C (23/29 patients, 79%) and D (5/5 patients 100%). CONCLUSIONS: The AIS conversion outcome measure is poorly related to the ability to walk in traumatic SCI patients. Therefore, the authors recommend the use of functional ambulation recovery outcome measures in prognosticating the recovery of walking capacity and performance of patients with SCI.
Assuntos
Avaliação de Resultados em Cuidados de Saúde/métodos , Avaliação de Resultados em Cuidados de Saúde/normas , Recuperação de Função Fisiológica/fisiologia , Índice de Gravidade de Doença , Traumatismos da Medula Espinal/fisiopatologia , Caminhada/fisiologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Europa (Continente) , Feminino , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Exame Físico , Estudos Retrospectivos , Fatores de Tempo , Adulto JovemRESUMO
STUDY DESIGN: Prospective multicenter longitudinal cohort study. OBJECTIVE: To validate the prognostic value of the acute phase sacral sparing measurements with regard to chronic phase-independent ambulation in patients with traumatic spinal cord injury (SCI). SETTING: European Multicenter Study of Human Spinal Cord Injury (EM-SCI). METHODS: In 432 patients, acute phase (0-15 days) American Spinal Injury Association (ASIA)/International Spinal Cord Society neurological standard scale (AIS) grades, ASIA sacral sparing measurements, which are S4-5 light touch (LT), S4-5 pin prick (PP), anal sensation and voluntary anal contraction; and chronic phase (6 or 12 months) indoor mobility Spinal Cord Independence Measure (SCIM) measurements were analyzed. Calculations of positive and negative predictive values (PPV/NPV) as well as univariate and multivariate logistic regressions were performed in all four sacral sparing criteria. The area under the receiver-operating characteristic curve (AUC) ratios of all regression equations was calculated. RESULTS: To achieve independent ambulation 1-year post injury, a normal S4-5 PP score showed the best PPV (96.5%, P<0.001, 95% confidence interval (95% CI): 87.9-99.6). Best NPV was reported in the S4-5 LT score (91.7%, P<0.001, 95% CI: 81.6-97.2). The use of the combination of only voluntary anal contraction and the S4-5 LT and PP sensory scores (AUC: 0.906, P<0.001, 95% CI: 0.871-0.941) showed significantly better (P<0.001, 95% CI: 0.038-0.128) discriminating results in prognosticating 1-year independent ambulation than with the use of currently used distinction between complete and incomplete SCI (AUC: 0.823, P<0.001, 95% CI: 0.781-0.864). CONCLUSIONS: Out of the four sacral sparing criteria, the acute phase anal sensory score measurements do not contribute significantly to the prognosis of independent ambulation. The combination of the acute phase voluntary anal contraction and the S4-5 LT and PP scores, predicts significantly better chronic phase-independent ambulation outcomes than the currently used distinction between complete and incomplete SCI. SPONSORSHIP: This study was granted by 'Acute Zorgregio Oost' and the 'Internationale Stiftung für Forschung in Paraplegie (IFP)'.
Assuntos
Avaliação da Deficiência , Índice de Gravidade de Doença , Traumatismos da Medula Espinal/diagnóstico , Traumatismos da Medula Espinal/fisiopatologia , Medula Espinal/fisiopatologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Canal Anal/inervação , Canal Anal/fisiopatologia , Estudos de Coortes , Diagnóstico Diferencial , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Exame Neurológico , Paralisia/diagnóstico , Paralisia/etiologia , Paralisia/fisiopatologia , Valor Preditivo dos Testes , Estudos Prospectivos , Reprodutibilidade dos Testes , Sacro , Distúrbios Somatossensoriais/diagnóstico , Distúrbios Somatossensoriais/etiologia , Distúrbios Somatossensoriais/fisiopatologia , Medula Espinal/patologia , Adulto JovemRESUMO
STUDY DESIGN: Literature review. OBJECTIVES: In traumatic spinal cord injury (SCI), much effort has been put into the evaluation of SCI severity and the prediction of recovery potential. An accurate prediction of the initial damage of the spinal cord that differentiates between the severities of SCI however, may help physicians in choosing a particular neuroprotective treatment in the acute phase. Neurochemical biomarkers may possibly fulfil these requirements. The aim of this review was to describe (1) the current status of neurochemical biomarkers in SCI; (2) their potential diagnostic role in SCI. METHODS: MEDLINE was searched from 1966 to 2008 to identify publications concerning biomarkers in traumatic SCI. RESULTS: The biomarkers S-100beta, neuron-specific enolase, neurofilament light chain, and Glial fibrillary acidic protein are significantly increased in cases of (experimental) spinal cord injury. Furthermore, increased serum concentrations of S-100beta have been correlated with an unfavourable functional outcome. Although biomarkers in SCI show promising results, considerations and shortcomings, such as polytrauma, haemolysis, extracerebral sources, and poor resuscitation, must be studied in greater detail before biomarkers can be utilised in the clinical care of SCI. CONCLUSIONS: Quantitative standards for determining the extent of SCI during the acute phase must be developed and validated. Even though increased concentrations of neurochemical biomarkers have been identified in patients with SCI, these do not yet provide a sensitive prognostic tool. Considering the limited availability of sensitive prognostic tools, neurochemical biomarkers of SCI should be evaluated and validated in future clinical trials.
Assuntos
Biomarcadores/metabolismo , Proteínas do Tecido Nervoso/metabolismo , Traumatismos da Medula Espinal/diagnóstico , Traumatismos da Medula Espinal/metabolismo , Animais , Humanos , MEDLINE/estatística & dados numéricos , Proteínas do Tecido Nervoso/classificação , Traumatismos da Medula Espinal/fisiopatologiaAssuntos
Causas de Morte , Vértebras Cervicais/lesões , Fraturas da Coluna Vertebral/mortalidade , Escala Resumida de Ferimentos , Acidentes por Quedas , Idoso , Idoso de 80 Anos ou mais , Avaliação Geriátrica , Humanos , Prognóstico , Medição de Risco , Sensibilidade e Especificidade , Traumatismos da Medula Espinal/diagnóstico , Traumatismos da Medula Espinal/mortalidade , Fraturas da Coluna Vertebral/diagnóstico , Fraturas da Coluna Vertebral/terapia , Análise de SobrevidaRESUMO
BACKGROUND: Although the non-operative management of closed humeral midshaft fractures has been advocated for years, the increasing popularity of operative intervention has left the optimal treatment choice unclear. OBJECTIVE: To compare the outcomes of operative and non-operative treatment of traumatic closed humeral midshaft fractures in adult patients. METHODS: A multicentre prospective comparative cohort study across 20 centres was conducted. Patients with AO type 12 A2, A3 and B2 fractures were treated with a functional brace or a retrograde-inserted unreamed humeral nail. Follow-up measurements were taken at 6, 12 and 52 weeks after the injury. The primary outcome was fracture healing after 1 year. Secondary outcomes included sub-items of the Constant score, general patient satisfaction, complications and cost-effectiveness parameters. Functions of the uninjured extremity were used as reference parameters. Intention-to-treat analysis was applied with the use of t-tests, Fisher's exact tests, Mann-Whitney U-tests and adjusted analysis of variance (ANOVA). RESULTS: Forty-seven patients were included. The patient sample consisted of 23 women and 24 men, with a mean age of 52.7 years (range 17-86 years). Of the 47 cases, 14 were treated non-operatively and 33 operatively. The follow-up rate at 1 year was 81%. After 1 year, 11 fractures (100%) healed in the non-operative group and at least 24 fractures (≥89%) healed in the operative group [1 non-union patient (4%) and no data for 2 patients (7%)]. There were no significant differences in pain, range of motion (ROM) of the shoulder and elbow, and return to work after 6 weeks, 12 weeks and 1 year. Although operatively treated patients showed significantly greater shoulder abduction strength (p = 0.036), elbow flexion strength (p = 0.021), functional hand positioning (p = 0.008) and return to recreational activities (p = 0.043) after 6 weeks, no statistically significant differences existed in any outcome measure at the 1-year follow-up. CONCLUSIONS: Our findings indicate that the non-operative management of humeral midshaft fractures can be expected to have similar functional outcomes and patient satisfaction at 1 year, despite an early benefit to operative treatment. If no radiological evidence of fracture healing exists in non-operatively treated patients during early follow-up, a switch to surgical treatment results in good functional outcomes and patient satisfaction.