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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.

Matsunaga FT, Tamaoki MJ, Matsumoto MH, dos Santos JB, Faloppa F, Belloti JC - Trials (2013)

Bottom Line: There is no good quality evidence advocating which method is more effective.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Orthopedics and Traumatology, Universidade Federal de São Paulo - Escola Paulista de Medicina (Unifesp-EPM), São Paulo, Brazil.

ABSTRACT

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).

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Postoperative radiography.
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Figure 5: Postoperative radiography.

Mentions: Patients randomised to surgical treatment will undergo preoperative evaluation of age, clinical condition (acute infection) and co-morbidities. The intervention will take place in the surgical centre of the institution, where four previously-specified surgeons, who are experienced with the surgical technique described by Livani and Belangero [24], will perform the surgical procedures. After the anaesthetic procedure, the patient will be kept in the horizontal dorsal decubitus position and two incisions will be made. The 3 to 5 cm proximal incision will access the proximal fragment between the biceps brachii muscle medially and the deltoid muscle laterally. The 3 to 5 cm distal incision will expose the anterior humeral cortex of the distal fragment, after dissection of the lateral cutaneous nerve of the forearm, and after the brachialis muscle is split longitudinally (Figure 4). In distal-third fractures, the lateral column of the distal humerus will be accessed with subperiosteal dissection of the lateral supracondylar crest and reflection of the brachioradialis and extensor carpi radialis longus muscles and the radial nerve. After indirect reduction under fluoroscopy, a narrow 4.5-mm dynamic compression plate (DCP) will be used and will be introduced in a proximal to distal direction (Figure 5). In fractures of the distal third of the humeral shaft, the plate will be introduced in a distal to proximal direction. Two to three screws will be inserted in each bone fragment. After osteosynthesis, final radiographs will be obtained, and the wound will be sutured and bandaged The patient will be kept immobilised with a sling until ambulatory evaluation.


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.

Matsunaga FT, Tamaoki MJ, Matsumoto MH, dos Santos JB, Faloppa F, Belloti JC - Trials (2013)

Postoperative radiography.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3750574&req=5

Figure 5: Postoperative radiography.
Mentions: Patients randomised to surgical treatment will undergo preoperative evaluation of age, clinical condition (acute infection) and co-morbidities. The intervention will take place in the surgical centre of the institution, where four previously-specified surgeons, who are experienced with the surgical technique described by Livani and Belangero [24], will perform the surgical procedures. After the anaesthetic procedure, the patient will be kept in the horizontal dorsal decubitus position and two incisions will be made. The 3 to 5 cm proximal incision will access the proximal fragment between the biceps brachii muscle medially and the deltoid muscle laterally. The 3 to 5 cm distal incision will expose the anterior humeral cortex of the distal fragment, after dissection of the lateral cutaneous nerve of the forearm, and after the brachialis muscle is split longitudinally (Figure 4). In distal-third fractures, the lateral column of the distal humerus will be accessed with subperiosteal dissection of the lateral supracondylar crest and reflection of the brachioradialis and extensor carpi radialis longus muscles and the radial nerve. After indirect reduction under fluoroscopy, a narrow 4.5-mm dynamic compression plate (DCP) will be used and will be introduced in a proximal to distal direction (Figure 5). In fractures of the distal third of the humeral shaft, the plate will be introduced in a distal to proximal direction. Two to three screws will be inserted in each bone fragment. After osteosynthesis, final radiographs will be obtained, and the wound will be sutured and bandaged The patient will be kept immobilised with a sling until ambulatory evaluation.

Bottom Line: There is no good quality evidence advocating which method is more effective.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Orthopedics and Traumatology, Universidade Federal de São Paulo - Escola Paulista de Medicina (Unifesp-EPM), São Paulo, Brazil.

ABSTRACT

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).

Show MeSH
Related in: MedlinePlus