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O estudo clínico NCT06981065 (ScanDiLaC) para Fratura da clavícula está em recrutamento. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Universidade de UppsalaThe Scandinavian Displaced Lateral Clavicle Trial (ScanDiLaC) 96
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT06981065 (ScanDiLaC) é um estudo intervencionista para Fratura da clavícula. Seu status atual é: em recrutamento. O estudo começou em 17 de setembro de 2025 e pretende incluir 96 participantes. Coordenado por a Universidade de Uppsala e deve ser concluído em 31 de dezembro de 2029. Essas informações foram atualizadas no ClinicalTrials.gov em 10 de dezembro de 2025.
Resumo
A multicentre multinational RCT to investigate whether non-surgical treatment is non-inferior to surgical treatment for displaced extraarticular lateral clavicle fractures in adults.
Descrição detalhada
The aim of this study is to investigate whether non-surgical treatment is non inferior to surgical treatment for displaced lateral clavicle fractures with regards to functional outcome measured with different patient-reported outcome measures. Patients aged 18-65 years will be randomized to non-surgical or surgical (pragmatic) treatment. The primary outcome is the Disabilities of Arm Hand and Shoulder (DASH) score at...Mostrar mais
Título oficial
The Scandinavian Displaced Lateral Clavicle Trial (ScanDiLaC) - A Multicentre, Pragmatic, 12-Month, Non-inferiority, Randomized Controlled Trial
Condições médicas
Fratura da clavículaOutros IDs do estudo
- ScanDiLaC
- 2025-01097-01
Número NCT
Data de início (real)
2025-09-17
Última atualização postada
2025-12-10
Data de conclusão (estimada)
2029-12-31
Inscrição (estimada)
96
Tipo de estudo
Intervencionista
FASE
N/A
Status
Em recrutamento
Palavras-chave
Displaced lateral clavicle fracture
Non-surgical
Surgical
PROMs
Health economy
Non-inferior
Complications
Non-surgical
Surgical
PROMs
Health economy
Non-inferior
Complications
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalNon-surgical Non-surgical treatment with a simple sling and physiotherapy. Cross-over option at 6 weeks if signs of symptomatic delayed union, non-decreasing pain, and patient requests surgery | Simple Sling and Physiotherapy Non-surgical treatment with a simple sling and physiotherapy according to standardized program. |
Comparador ativoSurgical Surgical treatment with plate and screws | Tratamento Cirúrgico Surgical treatment with plate and screws (lateral clavicle plate, clavicle plate or hook plate with/without coracoclavicular fixation). |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Disabilites of the Arm, Shoulder and Hand (DASH) | A 30-item patient-reported outcome measure concerning shoulder, arm and hand function, with two additional 4-item modules concerning work and sports function.
Min: 0 Max: 100. 0 representing no disability and 100 representing the most severe disability. A DASH score of 50 or more is often considered a cutoff for the presence of severe disability, while 20 or more suggests a medium level of disability. | 1 year |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Disabilites of the Arm, Shoulder and Hand (DASH) | A 30-item patient-reported outcome measure concerning shoulder, arm and hand function, with two additional 4-item modules concerning work and sports function.
Min: 0 Max: 100 0 representing no disability and 100 representing the most severe disability. A DASH score of 50 or more is often considered a cutoff for the presence of severe disability, while 20 or more suggests a medium level of disability. | Pre-injury, 6 weeks, 3 months, 6 months, 2 years, 5 years |
Nottingham Clavicle Score (NCS) | A 10-item disease-specific PROM concerning functional outcome after injuries and diseases around the clavicle.
The minimum possible score is 20, and the maximum is 100. A higher score indicates better functional ability, while a lower score suggests greater functional disability. The NCS can be graded as excellent (80-100), good (60-79), fair (40-59), or poor (\<40). | 6 weeks, 3 months, 6 months, 1, 2, 5 years |
University of California, Los Angeles (UCLA) Activity scale | An activity scale measured in 10 levels. It ranges from 1 to 10, with 1 representing no physical activity and 10 representing regular participation in impact sports. | Pre-injury, 6 weeks, 3 months, 6 months, 1 years |
EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire | Health-Related Quality of Life (HRQoL) measured in 5 Levels. The minimum and maximum possible outcomes for EQ-5D-5L index scores are -0.573 and 1, respectively. The minimum value represents a health state considered worse than death, while 1 represents full health. | Pre-injury, 6 weeks, 3 months, 6 months, 1, 2, 5 years |
Visual Analog Scale (VAS) for pain | Pain measure by visual analog scale in 11 levels. Minimum 0 and maximum 10. Higher figure indicates more pain. 10 is maximum pain. | Baseline, 6 weeks, 3 months, 6 months, 1, 2, 5 years |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
- Displaced extraarticular lateral clavicle fracture (type II or V according to the modified Neer classification)
- Pathological fracture
- Open fracture
- Neurovascular injury
- Same-time fracture in the upper extremity
- Polytrauma
- Contraindications to surgery and/or anesthesia
- Unable to give informed consent
- Inability to complete follow-up
Universidade de UppsalaContato central do estudo
Contato: Pontus Christersson, MD, PhD Student, +46-18-6110000, [email protected]
11 Locais do estudo em 4 países
Odense University Hospital, Odense, Denmark
Bjarke Viberg, Contato, [email protected]
Ainda não recrutando
Tampere University Hospital, Tampere, Finland
Antti Launonen, Contato, [email protected]
Ainda não recrutando
Østfold Hospital Trust, Fredrikstad, Norway
Frede Frihagen, Contato, [email protected]
Ainda não recrutando
Kalmar Regional Hospital, Kalmar, Sweden
Mats Ranbebo, Contato, +46103580000, [email protected]
Em recrutamento
Linköping University Hospital, Linköping, Sweden
Johan Scheer, Contato, +46-10-1030000, [email protected]
Em recrutamento
Skane University Hospital, Malmo, Sweden
Jonas Nordin, Contato, +46-40-331000, [email protected]
Em recrutamento
Örebro University Hospital, Örebro, Sweden
Per Fischer, Contato, +46-19-6021000, [email protected]
Em recrutamento
Danderyd Hospital, Stockholm, Sweden
Viktor Mili-Schmidt, Contato, +46-8-12355000, [email protected]
Em recrutamento
Stockholm South Hospital, Stockholm, Sweden
Johanna Rundgren, Contato, +46812361000, [email protected]
Em recrutamento
Norrlands University Hospital, Umeå, Sweden
Jonas Sundkvist, Contato, +46-90-7850000, [email protected]
Em recrutamento
Uppsala University Hopsital, Uppsala, Sweden
Pontus Christersson, Contato, +46-18-6110000, [email protected]
Em recrutamento