Effectiveness and cost-effectiveness of primary arthrodesis versus open reduction and internal fixation in patients with Lisfranc fracture instability (The BFF Study) study protocol for a multicenter randomized controlled trial
The Lisfranc injury is a complex injury of the midfoot. It can result in persistent pain and functional impairment if treated inappropriately. In Lisfranc fracture dislocation, treatment options are primary arthrodesis of the midfoot joints or open reduction and internal fixation. The purpose of the...
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| Veröffentlicht in: | BMC surgery 2021-08, Vol.21 (1), p.1-323, Article 323 |
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| description | The Lisfranc injury is a complex injury of the midfoot. It can result in persistent pain and functional impairment if treated inappropriately. In Lisfranc fracture dislocation, treatment options are primary arthrodesis of the midfoot joints or open reduction and internal fixation. The purpose of the proposed study is to define the optimal treatment for the Lisfranc fracture dislocation, either primary arthrodesis or open reduction and internal fixation, in regard to quality of life, complications, functional outcomes, and cost effectiveness. This study protocol provides a comprehensive overview of the aims and methods of the attached clinical study. Limitations of this study are the absence of patient blinding since it is impossible in surgical intervention, and the outcome measure (AOFAS) that has limited validity not for these injuries. This study will be the first with enough power to define optimal treatment for Lisfranc fracture dislocations. This is necessary since current literature is unclear on this topic. |
| doi_str_mv | 10.1186/s12893-021-01320-1 |
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A. C. ; Stollenwerck, G. A. N. L. ; Evers, S. M. A. A. ; Poeze, M.</creator><creatorcontrib>van den Boom, N. A. C. ; Stollenwerck, G. A. N. L. ; Evers, S. M. A. A. ; Poeze, M.</creatorcontrib><description>The Lisfranc injury is a complex injury of the midfoot. It can result in persistent pain and functional impairment if treated inappropriately. In Lisfranc fracture dislocation, treatment options are primary arthrodesis of the midfoot joints or open reduction and internal fixation. The purpose of the proposed study is to define the optimal treatment for the Lisfranc fracture dislocation, either primary arthrodesis or open reduction and internal fixation, in regard to quality of life, complications, functional outcomes, and cost effectiveness. This study protocol provides a comprehensive overview of the aims and methods of the attached clinical study. Limitations of this study are the absence of patient blinding since it is impossible in surgical intervention, and the outcome measure (AOFAS) that has limited validity not for these injuries. This study will be the first with enough power to define optimal treatment for Lisfranc fracture dislocations. This is necessary since current literature is unclear on this topic.</description><identifier>ISSN: 1471-2482</identifier><identifier>EISSN: 1471-2482</identifier><identifier>DOI: 10.1186/s12893-021-01320-1</identifier><identifier>PMID: 34384419</identifier><language>eng</language><publisher>London: BioMed Central Ltd</publisher><subject>Activities of daily living ; Anesthesia ; Arthritis ; Arthrodesis ; Care and treatment ; Clinical trials ; Complications ; Control stability ; Cost analysis ; Cost effectiveness ; Dislocation ; Economic aspects ; Evaluation ; Fixation ; Fluoroscopy ; Foot diseases ; Fractures ; Injuries ; Injury prevention ; Internal fixation in fractures ; Medical research ; Medicine, Experimental ; ORIF ; Pain ; Parameters ; Patients ; Population studies ; Quality of life ; Radiographs ; Radiography ; Study Protocol ; Trauma ; Traumatic Lisfranc fracture dislocation</subject><ispartof>BMC surgery, 2021-08, Vol.21 (1), p.1-323, Article 323</ispartof><rights>COPYRIGHT 2021 BioMed Central Ltd.</rights><rights>2021. 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A. C.</creatorcontrib><creatorcontrib>Stollenwerck, G. A. N. L.</creatorcontrib><creatorcontrib>Evers, S. M. A. A.</creatorcontrib><creatorcontrib>Poeze, M.</creatorcontrib><title>Effectiveness and cost-effectiveness of primary arthrodesis versus open reduction and internal fixation in patients with Lisfranc fracture instability (The BFF Study) study protocol for a multicenter randomized controlled trial</title><title>BMC surgery</title><description>The Lisfranc injury is a complex injury of the midfoot. It can result in persistent pain and functional impairment if treated inappropriately. In Lisfranc fracture dislocation, treatment options are primary arthrodesis of the midfoot joints or open reduction and internal fixation. The purpose of the proposed study is to define the optimal treatment for the Lisfranc fracture dislocation, either primary arthrodesis or open reduction and internal fixation, in regard to quality of life, complications, functional outcomes, and cost effectiveness. This study protocol provides a comprehensive overview of the aims and methods of the attached clinical study. Limitations of this study are the absence of patient blinding since it is impossible in surgical intervention, and the outcome measure (AOFAS) that has limited validity not for these injuries. This study will be the first with enough power to define optimal treatment for Lisfranc fracture dislocations. This is necessary since current literature is unclear on this topic.</description><subject>Activities of daily living</subject><subject>Anesthesia</subject><subject>Arthritis</subject><subject>Arthrodesis</subject><subject>Care and treatment</subject><subject>Clinical trials</subject><subject>Complications</subject><subject>Control stability</subject><subject>Cost analysis</subject><subject>Cost effectiveness</subject><subject>Dislocation</subject><subject>Economic aspects</subject><subject>Evaluation</subject><subject>Fixation</subject><subject>Fluoroscopy</subject><subject>Foot diseases</subject><subject>Fractures</subject><subject>Injuries</subject><subject>Injury prevention</subject><subject>Internal fixation in fractures</subject><subject>Medical research</subject><subject>Medicine, Experimental</subject><subject>ORIF</subject><subject>Pain</subject><subject>Parameters</subject><subject>Patients</subject><subject>Population studies</subject><subject>Quality of life</subject><subject>Radiographs</subject><subject>Radiography</subject><subject>Study Protocol</subject><subject>Trauma</subject><subject>Traumatic Lisfranc fracture dislocation</subject><issn>1471-2482</issn><issn>1471-2482</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>BENPR</sourceid><sourceid>DOA</sourceid><recordid>eNpdks1uEzEQx1cIREvhBThZ4lIOCx57P7wXpLZqoVIkDpSz5fWOE0cbO9jeQHldXgRvEgHh4hnN_P2bGXuK4jXQdwCieR-BiY6XlEFJgTNawpPiHKoWSlYJ9vQf_6x4EeOaUmhFXT8vznjFRVVBd178ujUGdbI7dBgjUW4g2sdU4knYG7INdqPCI1EhrYIfMNpIdhjilLNbdCTgMOUL3u0Z1iUMTo3E2B9qH7WObLOHLkXy3aYVWdhognKa5FOnKWCWxKR6O9r0SC4fVkiu7-7IlzQNj29JnE1uwievfcb6QBTZTGOyGudaJKMGv7E_cR7ApeDHMbspWDW-LJ4ZNUZ8dbQXxde724ebT-Xi88f7m6tFqWsKqWx7M0AHuu-14AZYgxXU0CnGem646BhSQ03LuRKgaQWagW5Y17UNFW0DDb8o7g_cwau1PD6Y9MrKfcCHpcyvZ_WIUjcV021naiaGqs9I3ilhaK7Q5jiyzPpwYG2nfoPDPGRQ4wn0NOPsSi79Tgped7RuM-DyCAj-24QxyY2NGsdROfRTlKxuoBJNJ2iWvvlPuvbT_Ht7FeMthab9q1qqPIB1xue6eobKq6ZlnEJdQVaxg0oHH2NA86dloHLeWnnYWpm3Vu63VgL_DelX43s</recordid><startdate>20210812</startdate><enddate>20210812</enddate><creator>van den Boom, N. 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The purpose of the proposed study is to define the optimal treatment for the Lisfranc fracture dislocation, either primary arthrodesis or open reduction and internal fixation, in regard to quality of life, complications, functional outcomes, and cost effectiveness. This study protocol provides a comprehensive overview of the aims and methods of the attached clinical study. Limitations of this study are the absence of patient blinding since it is impossible in surgical intervention, and the outcome measure (AOFAS) that has limited validity not for these injuries. This study will be the first with enough power to define optimal treatment for Lisfranc fracture dislocations. This is necessary since current literature is unclear on this topic.</abstract><cop>London</cop><pub>BioMed Central Ltd</pub><pmid>34384419</pmid><doi>10.1186/s12893-021-01320-1</doi><oa>free_for_read</oa></addata></record> |
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| source | Springer Online Journals Complete; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; Springer Nature OA/Free Journals; PubMed Central Open Access |
| subjects | Activities of daily living Anesthesia Arthritis Arthrodesis Care and treatment Clinical trials Complications Control stability Cost analysis Cost effectiveness Dislocation Economic aspects Evaluation Fixation Fluoroscopy Foot diseases Fractures Injuries Injury prevention Internal fixation in fractures Medical research Medicine, Experimental ORIF Pain Parameters Patients Population studies Quality of life Radiographs Radiography Study Protocol Trauma Traumatic Lisfranc fracture dislocation |
| title | Effectiveness and cost-effectiveness of primary arthrodesis versus open reduction and internal fixation in patients with Lisfranc fracture instability (The BFF Study) study protocol for a multicenter randomized controlled trial |
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