Functional orthosis versus cast immobilization for weightbearing stable Weber B ankle fractures with concomitant unstable gravity stress tests: a protocol for a two-year multicentre randomized controlled noninferiority trial
Aims: Treatment of Weber B ankle fractures that are stable on weightbearing radiographs but unstable on concomitant stress tests (classified SER4a) is controversial. Recent studies indicate that these fractures should be treated nonoperatively, but no studies have compared alternative nonoperative o...
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| Format: | Article |
| Language: | English |
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The British Editorial Society of Bone & Joint Surgery
2023-09-01
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| Series: | Bone & Joint Open |
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| Online Access: | https://online.boneandjoint.org.uk/doi/epdf/10.1302/2633-1462.49.BJO-2023-0012.R1 |
| _version_ | 1797672307360006144 |
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| author | Martin G. Gregersen Ragnhild T. Justad-Berg Nicolaj E. Q. Gill Ola Saatvedt Lars K. Aas Marius Molund |
| author_facet | Martin G. Gregersen Ragnhild T. Justad-Berg Nicolaj E. Q. Gill Ola Saatvedt Lars K. Aas Marius Molund |
| author_sort | Martin G. Gregersen |
| collection | DOAJ |
| description | Aims: Treatment of Weber B ankle fractures that are stable on weightbearing radiographs but unstable on concomitant stress tests (classified SER4a) is controversial. Recent studies indicate that these fractures should be treated nonoperatively, but no studies have compared alternative nonoperative options. This study aims to evaluate patient-reported outcomes and the safety of fracture treatment using functional orthosis versus cast immobilization. Methods: A total of 110 patients with Weber B/SER4a ankle fractures will be randomized (1:1 ratio) to receive six weeks of functional orthosis treatment or cast immobilization with a two-year follow-up. The primary outcome is patient-reported ankle function and symptoms measured by the Manchester-Oxford Foot and Ankle Questionnaire (MOxFQ); secondary outcomes include Olerud-Molander Ankle Score, radiological evaluation of ankle congruence in weightbearing and gravity stress tests, and rates of treatment-related adverse events. The Regional Committee for Medical and Health Research (approval number 277693) has granted ethical approval, and the study is funded by South-Eastern Norway Regional Health Authority (grant number 2023014). Discussion: Randomized controlled trials are needed to evaluate alternative nonoperative treatment options for Weber B/SER4a ankle fractures, as current clinical guidelines are based on biomechanical reasoning. The findings will be shared through publication in peer-reviewed journals and presentations at conferences. Cite this article: Bone Jt Open 2023;4(9):713–719. |
| first_indexed | 2024-03-11T21:28:03Z |
| format | Article |
| id | doaj.art-98124605ff5149a48a0d17a80d30f131 |
| institution | Directory Open Access Journal |
| issn | 2633-1462 |
| language | English |
| last_indexed | 2024-03-11T21:28:03Z |
| publishDate | 2023-09-01 |
| publisher | The British Editorial Society of Bone & Joint Surgery |
| record_format | Article |
| series | Bone & Joint Open |
| spelling | doaj.art-98124605ff5149a48a0d17a80d30f1312023-09-27T14:59:50ZengThe British Editorial Society of Bone & Joint SurgeryBone & Joint Open2633-14622023-09-014971371910.1302/2633-1462.49.BJO-2023-0012.R1Functional orthosis versus cast immobilization for weightbearing stable Weber B ankle fractures with concomitant unstable gravity stress tests: a protocol for a two-year multicentre randomized controlled noninferiority trialMartin G. Gregersen0https://orcid.org/0000-0001-9941-4518Ragnhild T. Justad-Berg1Nicolaj E. Q. Gill2Ola Saatvedt3https://orcid.org/0009-0009-8638-9195Lars K. Aas4Marius Molund5https://orcid.org/0000-0003-1683-8214Department of Physical Medicine and Rehabilitation, Østfold Hospital Trust, Grålum, NorwayOrthopaedic Department, Møre og Romsdal Hospital Trust, Ålesund Hospital, Alesund, NorwayDepartment of Orthopaedic Surgery, Innlandet Hospital Trust, Gjøvik Hospital, Gjøvik, NorwayDepartment of Orthopaedic Surgery, Innlandet Hospital Trust, Gjøvik Hospital, Gjøvik, NorwayOrthopaedic Department, Møre og Romsdal Hospital Trust, Ålesund Hospital, Alesund, NorwayDepartment of Orthopaedic Surgery, Østfold Hospital Trust, Grålum, NorwayAims: Treatment of Weber B ankle fractures that are stable on weightbearing radiographs but unstable on concomitant stress tests (classified SER4a) is controversial. Recent studies indicate that these fractures should be treated nonoperatively, but no studies have compared alternative nonoperative options. This study aims to evaluate patient-reported outcomes and the safety of fracture treatment using functional orthosis versus cast immobilization. Methods: A total of 110 patients with Weber B/SER4a ankle fractures will be randomized (1:1 ratio) to receive six weeks of functional orthosis treatment or cast immobilization with a two-year follow-up. The primary outcome is patient-reported ankle function and symptoms measured by the Manchester-Oxford Foot and Ankle Questionnaire (MOxFQ); secondary outcomes include Olerud-Molander Ankle Score, radiological evaluation of ankle congruence in weightbearing and gravity stress tests, and rates of treatment-related adverse events. The Regional Committee for Medical and Health Research (approval number 277693) has granted ethical approval, and the study is funded by South-Eastern Norway Regional Health Authority (grant number 2023014). Discussion: Randomized controlled trials are needed to evaluate alternative nonoperative treatment options for Weber B/SER4a ankle fractures, as current clinical guidelines are based on biomechanical reasoning. The findings will be shared through publication in peer-reviewed journals and presentations at conferences. Cite this article: Bone Jt Open 2023;4(9):713–719.https://online.boneandjoint.org.uk/doi/epdf/10.1302/2633-1462.49.BJO-2023-0012.R1ankle fracturedeltoid ligamentnonoperative treatmentweber b ankle fracturescast immobilizationstress testsorthotic devicesanklesankle fracturesradiographymoxfq scorepatient-reported outcomesnonoperative treatment |
| spellingShingle | Martin G. Gregersen Ragnhild T. Justad-Berg Nicolaj E. Q. Gill Ola Saatvedt Lars K. Aas Marius Molund Functional orthosis versus cast immobilization for weightbearing stable Weber B ankle fractures with concomitant unstable gravity stress tests: a protocol for a two-year multicentre randomized controlled noninferiority trial Bone & Joint Open ankle fracture deltoid ligament nonoperative treatment weber b ankle fractures cast immobilization stress tests orthotic devices ankles ankle fractures radiography moxfq score patient-reported outcomes nonoperative treatment |
| title | Functional orthosis versus cast immobilization for weightbearing stable Weber B ankle fractures with concomitant unstable gravity stress tests: a protocol for a two-year multicentre randomized controlled noninferiority trial |
| title_full | Functional orthosis versus cast immobilization for weightbearing stable Weber B ankle fractures with concomitant unstable gravity stress tests: a protocol for a two-year multicentre randomized controlled noninferiority trial |
| title_fullStr | Functional orthosis versus cast immobilization for weightbearing stable Weber B ankle fractures with concomitant unstable gravity stress tests: a protocol for a two-year multicentre randomized controlled noninferiority trial |
| title_full_unstemmed | Functional orthosis versus cast immobilization for weightbearing stable Weber B ankle fractures with concomitant unstable gravity stress tests: a protocol for a two-year multicentre randomized controlled noninferiority trial |
| title_short | Functional orthosis versus cast immobilization for weightbearing stable Weber B ankle fractures with concomitant unstable gravity stress tests: a protocol for a two-year multicentre randomized controlled noninferiority trial |
| title_sort | functional orthosis versus cast immobilization for weightbearing stable weber b ankle fractures with concomitant unstable gravity stress tests a protocol for a two year multicentre randomized controlled noninferiority trial |
| topic | ankle fracture deltoid ligament nonoperative treatment weber b ankle fractures cast immobilization stress tests orthotic devices ankles ankle fractures radiography moxfq score patient-reported outcomes nonoperative treatment |
| url | https://online.boneandjoint.org.uk/doi/epdf/10.1302/2633-1462.49.BJO-2023-0012.R1 |
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