Treatment of the humeral shaft fractures-minimally invasive osteosynthesis with bridge plate versus conservative treatment with functional brace : study protocol for a randomised controlled trial

Background: Humeral shaft fractures account for 1 to 3% of all fractures in adults and for 20% of all humeral fractures. Non-operative treatment is still the standard treatment of isolated humeral shaft fractures, although this method can present unsatisfactory results. Surgical treatment is reserved for specific conditions. Modern concepts of internal fixation of long bone shaft fractures advocate relative stabilisation techniques with no harm to fracture zone. Recently described, minimally invasive bridge plate osteosynthesis has been shown to be a secure technique with good results for treating humeral shaft fractures. There is no good quality evidence advocating which method is more effective. This randomised controlled trial will be performed to investigate the effectiveness of surgical treatment of humeral shaft fractures with bridge plating in comparison with conservative treatment with functional brace. Methods/Design: This randomised clinical trial aims to include 110 patients with humeral shaft fractures who will be allocated after randomisation to one of the two groups: bridge plate or functional brace. Surgical treatment will be performed according to technique described by Livani and Belangero using a narrow DCP plate. Non-operative management will consist of a functional brace for 6 weeks or until fracture consolidation. All patients will be included in the same rehabilitation program and will be followed up for 1 year after intervention. The primary outcome will be the DASH score after 6 months of intervention. As secondary outcomes, we will assess SF-36 questionnaire, treatment complications, Constant score, pain (Visual Analogue Scale) and radiographs. Discussion: According to current evidence shown in a recent systematic review, this study is one of the first randomised controlled trials designed to compare two methods to treat humeral shaft fractures (functional brace and bridge plate surgery). Trial registration: Current Controlled Trials: ISRCTN24835397

Objectives: This study aims to compare two methods of treatment of humeral shaft fractures: one nonsurgical and one surgical method. The objective is to evaluate which of the two methods of treatment is most effective.

Procedures:
If I agree to participate in this study and be selected to surgical treatment group: 1-I will undergo to a surgical procedure, which consist to insert a plate and screws for fixation of bone fragments.
2-Radiographs will be taken from my arm during the returns to monitoring radiological evolution of the fracture.
3-I will stay with a sling for seven to ten days.
4-I will follow this hospital to control the fracture weekly until the sixth weeks and after 3,6,12 and 24 months.
If I agree to participate in this study and be selected to nonsurgical treatment group: 1-I will be treated with a brace for a period of approximately 8 weeks 2-Radiographs will be taken from my arm during the returns to monitoring radiological evolution of the fracture.
3-I will follow this hospital to control the fracture weekly until the sixth weeks and after 3,6,12 and 24 months.
All these procedures are supported by the literature and there is no consensus about which is the best method of treatment.
There will be no risk or discomfort beyond the expected for treatment of humeral fractures. (Examples of risks inherent to the treatment of humeral fractures: anesthaetic risk, discomfort when using the brace, pain at the surgery site, pain at the fracture site).
There is no direct benefit to the participant. This is an experimental study.
Only at the end of the study we can conclude the presence of some benefit.
Guaranteed access: at any stage of the study, you will have access to professionals responsible for research to clarify any doubts.
If you have any doubt or consideration about the ethical aspect of the research, please contact the Research Ethics Committee (CEP) -Rua Botucatu 572 1 ̊ And cj 14, 5571-1062, FAX: 5539-7162. Email: cepunifesp@epm.br.
It is guaranteed freedom of withdrawal of consent at any time and stop participating the study with no harm to the continuation of the treatment at the institution.
Right to Confidentiality: the information obtained will be analysed together with other patients, not being disclosed to identify any patient.
Right to be kept updated about the partial results of the research, when in open studies, or results which are known to the researchers.
Expenses and Compensation: no personal expenses for the participant at any stage of the study, including exams and consultations. There is also no financial compensation for their participation.
If there is any additional expense, it will be absorbed by the budget of the research.
In case of personal injury directly caused by the procedures or treatments proposed in this study, the participant is entitled to medical treatment at the institution, as well as the legally established compensation.
Commitment of the researcher to use the data and material collected for this research only. I believe I have been sufficiently informed about the information that I have read or been read to me, describing the study " Treatment of Humeral