Open reduction and internal fixation of humeral shaft fractures versus conservative treatment with a functional brace: a study protocol of a randomised controlled trial embedded in a cohort
IntroductionHumeral shaft fractures represent 1%–3% of all fractures and 20% of humeral fractures in adults. The treatment of these fractures is mainly conservative and operative treatment is usually reserved for specific circumstances. To date, no randomised controlled trial (RCT) has compared oper...
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| Veröffentlicht in: | BMJ open Jg. 7; H. 7; S. e014076 |
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| Abstract | IntroductionHumeral shaft fractures represent 1%–3% of all fractures and 20% of humeral fractures in adults. The treatment of these fractures is mainly conservative and operative treatment is usually reserved for specific circumstances. To date, no randomised controlled trial (RCT) has compared operative treatment of humeral shaft fractures with conservative treatment.Methods and analysisWe will conduct an RCT to compare the effectiveness and cost-effectiveness of surgical and conservative treatment of humeral shaft fractures. After providing informed consent, 80 patients from 18 years of age with humeral shaft fracture will be randomly assigned to open reduction and internal fixation with locking plate or conservative treatment with functional bracing. We will follow the patients for 10 years and compare the results at different time points. The primary outcome will be Disabilities of Arm, Shoulder and Hand (DASH) at 12 months. The secondary outcomes will include Numerical Rating Scale for pain at rest and in activities, Constant Score and quality of life instrument 15D. Patients not willing to participate in the RCT will be asked to participate in a prospective cohort follow-up study, ‘the declined cohort’. This cohort will be followed up at the same time points as the randomised patients to assess the potential effect of participation bias on RCT results and to enhance the external validity of the RCT. In one of the recruiting centres, all cooperative patients with humeral shaft fractures not eligible for randomisation will be asked to participate in a ‘non-eligible cohort’ study. We will use blinded data interpretation of the randomised cohort to avoid biased interpretation of outcomes. Our null hypothesis is that there is no clinically relevant difference in the primary outcome measure between the two treatment groups. We will consider a difference of a minimum of 10 points in DASH clinically relevant.Ethics and disseminationThe institutional review board of the Helsinki and Uusimaa Hospital District has approved the protocol. We will disseminate the findings of this study through peer-reviewed publications and conference presentations.Trial registration numberNCT01719887; pre-results. |
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| AbstractList | Humeral shaft fractures represent 1%-3% of all fractures and 20% of humeral fractures in adults. The treatment of these fractures is mainly conservative and operative treatment is usually reserved for specific circumstances. To date, no randomised controlled trial (RCT) has compared operative treatment of humeral shaft fractures with conservative treatment.
We will conduct an RCT to compare the effectiveness and cost-effectiveness of surgical and conservative treatment of humeral shaft fractures. After providing informed consent, 80 patients from 18 years of age with humeral shaft fracture will be randomly assigned to open reduction and internal fixation with locking plate or conservative treatment with functional bracing. We will follow the patients for 10 years and compare the results at different time points. The primary outcome will be Disabilities of Arm, Shoulder and Hand (DASH) at 12 months. The secondary outcomes will include Numerical Rating Scale for pain at rest and in activities, Constant Score and quality of life instrument 15D. Patients not willing to participate in the RCT will be asked to participate in a prospective cohort follow-up study, 'the declined cohort'. This cohort will be followed up at the same time points as the randomised patients to assess the potential effect of participation bias on RCT results and to enhance the external validity of the RCT. In one of the recruiting centres, all cooperative patients with humeral shaft fractures not eligible for randomisation will be asked to participate in a 'non-eligible cohort' study. We will use blinded data interpretation of the randomised cohort to avoid biased interpretation of outcomes. Our null hypothesis is that there is no clinically relevant difference in the primary outcome measure between the two treatment groups. We will consider a difference of a minimum of 10 points in DASH clinically relevant.
The institutional review board of the Helsinki and Uusimaa Hospital District has approved the protocol. We will disseminate the findings of this study through peer-reviewed publications and conference presentations.
NCT01719887; pre-results. IntroductionHumeral shaft fractures represent 1%–3% of all fractures and 20% of humeral fractures in adults. The treatment of these fractures is mainly conservative and operative treatment is usually reserved for specific circumstances. To date, no randomised controlled trial (RCT) has compared operative treatment of humeral shaft fractures with conservative treatment.Methods and analysisWe will conduct an RCT to compare the effectiveness and cost-effectiveness of surgical and conservative treatment of humeral shaft fractures. After providing informed consent, 80 patients from 18 years of age with humeral shaft fracture will be randomly assigned to open reduction and internal fixation with locking plate or conservative treatment with functional bracing. We will follow the patients for 10 years and compare the results at different time points. The primary outcome will be Disabilities of Arm, Shoulder and Hand (DASH) at 12 months. The secondary outcomes will include Numerical Rating Scale for pain at rest and in activities, Constant Score and quality of life instrument 15D. Patients not willing to participate in the RCT will be asked to participate in a prospective cohort follow-up study, ‘the declined cohort’. This cohort will be followed up at the same time points as the randomised patients to assess the potential effect of participation bias on RCT results and to enhance the external validity of the RCT. In one of the recruiting centres, all cooperative patients with humeral shaft fractures not eligible for randomisation will be asked to participate in a ‘non-eligible cohort’ study. We will use blinded data interpretation of the randomised cohort to avoid biased interpretation of outcomes. Our null hypothesis is that there is no clinically relevant difference in the primary outcome measure between the two treatment groups. We will consider a difference of a minimum of 10 points in DASH clinically relevant.Ethics and disseminationThe institutional review board of the Helsinki and Uusimaa Hospital District has approved the protocol. We will disseminate the findings of this study through peer-reviewed publications and conference presentations.Trial registration numberNCT01719887; pre-results. Humeral shaft fractures represent 1%-3% of all fractures and 20% of humeral fractures in adults. The treatment of these fractures is mainly conservative and operative treatment is usually reserved for specific circumstances. To date, no randomised controlled trial (RCT) has compared operative treatment of humeral shaft fractures with conservative treatment.INTRODUCTIONHumeral shaft fractures represent 1%-3% of all fractures and 20% of humeral fractures in adults. The treatment of these fractures is mainly conservative and operative treatment is usually reserved for specific circumstances. To date, no randomised controlled trial (RCT) has compared operative treatment of humeral shaft fractures with conservative treatment.We will conduct an RCT to compare the effectiveness and cost-effectiveness of surgical and conservative treatment of humeral shaft fractures. After providing informed consent, 80 patients from 18 years of age with humeral shaft fracture will be randomly assigned to open reduction and internal fixation with locking plate or conservative treatment with functional bracing. We will follow the patients for 10 years and compare the results at different time points. The primary outcome will be Disabilities of Arm, Shoulder and Hand (DASH) at 12 months. The secondary outcomes will include Numerical Rating Scale for pain at rest and in activities, Constant Score and quality of life instrument 15D. Patients not willing to participate in the RCT will be asked to participate in a prospective cohort follow-up study, 'the declined cohort'. This cohort will be followed up at the same time points as the randomised patients to assess the potential effect of participation bias on RCT results and to enhance the external validity of the RCT. In one of the recruiting centres, all cooperative patients with humeral shaft fractures not eligible for randomisation will be asked to participate in a 'non-eligible cohort' study. We will use blinded data interpretation of the randomised cohort to avoid biased interpretation of outcomes. Our null hypothesis is that there is no clinically relevant difference in the primary outcome measure between the two treatment groups. We will consider a difference of a minimum of 10 points in DASH clinically relevant.METHODS AND ANALYSISWe will conduct an RCT to compare the effectiveness and cost-effectiveness of surgical and conservative treatment of humeral shaft fractures. After providing informed consent, 80 patients from 18 years of age with humeral shaft fracture will be randomly assigned to open reduction and internal fixation with locking plate or conservative treatment with functional bracing. We will follow the patients for 10 years and compare the results at different time points. The primary outcome will be Disabilities of Arm, Shoulder and Hand (DASH) at 12 months. The secondary outcomes will include Numerical Rating Scale for pain at rest and in activities, Constant Score and quality of life instrument 15D. Patients not willing to participate in the RCT will be asked to participate in a prospective cohort follow-up study, 'the declined cohort'. This cohort will be followed up at the same time points as the randomised patients to assess the potential effect of participation bias on RCT results and to enhance the external validity of the RCT. In one of the recruiting centres, all cooperative patients with humeral shaft fractures not eligible for randomisation will be asked to participate in a 'non-eligible cohort' study. We will use blinded data interpretation of the randomised cohort to avoid biased interpretation of outcomes. Our null hypothesis is that there is no clinically relevant difference in the primary outcome measure between the two treatment groups. We will consider a difference of a minimum of 10 points in DASH clinically relevant.The institutional review board of the Helsinki and Uusimaa Hospital District has approved the protocol. We will disseminate the findings of this study through peer-reviewed publications and conference presentations.ETHICS AND DISSEMINATIONThe institutional review board of the Helsinki and Uusimaa Hospital District has approved the protocol. We will disseminate the findings of this study through peer-reviewed publications and conference presentations.NCT01719887; pre-results.TRIAL REGISTRATION NUMBERNCT01719887; pre-results. |
| Author | Rämö, Lasse Paavola, Mika Lähdeoja, Tuomas Taimela, Simo Lepola, Vesa Malmivaara, Antti |
| AuthorAffiliation | 3 Centre for Health and Social Economics , National Institute for Health and Welfare , Helsinki , Finland 2 Department of Orthopaedics and Traumatology , Tampere University Central Hospital , Tampere , Finland 1 Department of Orthopaedics and Traumatology , Helsinki University Central Hospital , Helsinki , Finland |
| AuthorAffiliation_xml | – name: 2 Department of Orthopaedics and Traumatology , Tampere University Central Hospital , Tampere , Finland – name: 1 Department of Orthopaedics and Traumatology , Helsinki University Central Hospital , Helsinki , Finland – name: 3 Centre for Health and Social Economics , National Institute for Health and Welfare , Helsinki , Finland |
| Author_xml | – sequence: 1 givenname: Lasse orcidid: 0000-0003-4154-8462 surname: Rämö fullname: Rämö, Lasse email: lasse.ramo@hus.fi organization: Department of Orthopaedics and Traumatology, Helsinki University Central Hospital, Helsinki, Finland – sequence: 2 givenname: Simo surname: Taimela fullname: Taimela, Simo email: lasse.ramo@hus.fi organization: Department of Orthopaedics and Traumatology, Helsinki University Central Hospital, Helsinki, Finland – sequence: 3 givenname: Vesa surname: Lepola fullname: Lepola, Vesa email: lasse.ramo@hus.fi organization: Department of Orthopaedics and Traumatology, Tampere University Central Hospital, Tampere, Finland – sequence: 4 givenname: Antti surname: Malmivaara fullname: Malmivaara, Antti email: lasse.ramo@hus.fi organization: Centre for Health and Social Economics, National Institute for Health and Welfare, Helsinki, Finland – sequence: 5 givenname: Tuomas surname: Lähdeoja fullname: Lähdeoja, Tuomas email: lasse.ramo@hus.fi organization: Department of Orthopaedics and Traumatology, Helsinki University Central Hospital, Helsinki, Finland – sequence: 6 givenname: Mika surname: Paavola fullname: Paavola, Mika email: lasse.ramo@hus.fi organization: Department of Orthopaedics and Traumatology, Helsinki University Central Hospital, Helsinki, Finland |
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| Keywords | humeral fractures pragmatic cohort functional bracing randomised controlled trial diaphysis operative treatment shaft |
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| Snippet | IntroductionHumeral shaft fractures represent 1%–3% of all fractures and 20% of humeral fractures in adults. The treatment of these fractures is mainly... Humeral shaft fractures represent 1%-3% of all fractures and 20% of humeral fractures in adults. The treatment of these fractures is mainly conservative and... |
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| SubjectTerms | Bone Plates Braces Conservative Treatment Evidence-based medicine Finland Follow-Up Studies Fracture Fixation, Internal - methods Fracture Healing Fractures Humans Humeral Fractures - surgery Humeral Fractures - therapy Humerus - surgery Hypotheses Logistic Models Neurological disorders Patients Prospective Studies Quality of Life Research Design Shoulder Sports injuries Surgery Surgical techniques Trauma Treatment Outcome |
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| Title | Open reduction and internal fixation of humeral shaft fractures versus conservative treatment with a functional brace: a study protocol of a randomised controlled trial embedded in a cohort |
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