Medial malleolus: Operative Or Non-operative (MOON) trial protocol - a prospective randomised controlled trial of operative versus non-operative management of associated medial malleolus fractures in unstable fractures of the ankle
Abstract Background There are limited data reporting the outcome of patients with non-operatively managed medial malleolus fractures compared to those treated surgically in the presence of fibular stabilisation for unstable fractures of the ankle. Conservative management could result in fewer compli...
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| Format: | Article |
| Language: | English |
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BMC
2019-09-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-019-3642-7 |
| _version_ | 1818319145486254080 |
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| author | Thomas H. Carter William M. Oliver Catriona Graham Andrew D. Duckworth Timothy O. White |
| author_facet | Thomas H. Carter William M. Oliver Catriona Graham Andrew D. Duckworth Timothy O. White |
| author_sort | Thomas H. Carter |
| collection | DOAJ |
| description | Abstract Background There are limited data reporting the outcome of patients with non-operatively managed medial malleolus fractures compared to those treated surgically in the presence of fibular stabilisation for unstable fractures of the ankle. Conservative management could result in fewer complications, reduced surgical time and lower cost. The purpose of this study is to determine if any difference exists in patient reported and surgical outcomes 1 year after surgery between operative and non-operative treatment of medial malleolar fractures in combination with stabilisation of the lateral malleolus. Methods/design This is a single-centre, prospective, randomised controlled trial that aims to randomise 154 participants with an unstable ankle fracture to ‘non-fixation’ (n = 77) or ‘fixation’ (n = 77) of an associated well-reduced medial malleolus fracture following fibular stabilisation. The study will include patients ≥ 16 years of age with a closed bimalleolar or trimalleolar ankle fracture who are able to consent, complete questionnaires in the English language, and complete follow-up over a 1-year period. Randomisation will occur intra-operatively when the medial malleolus fracture is deemed ‘well-reduced’, with 2 mm or less of fluoroscopic displacement. The technique for fixation of both the medial and lateral malleoli is at the discretion of the operating surgeon. Patient-reported, observer-rated, and radiographic assessments will be collected at baseline and then at the following post-operative assessment points: 2 weeks, 6 weeks and 1 year. Postal questionnaire outcome data will be collected at 3 and 6 months. The primary outcome measure will be the Olerud Molander Ankle Score (OMAS) at 1 year following surgery. Secondary outcome measures will include the Manchester-Oxford Foot Questionnaire (MOXFQ), EuroQol-5D (EQ-5D), pain, treatment satisfaction, time to return to activity, operative tourniquet time, and complications. Discussion There is only one previous randomised trial comparing non-fixation with fixation of associated medial malleolus fractures but that was limited by the lack of baseline patient-reported outcome data and an inferior sample size. This current prospective trial aims to provide high-quality evidence regarding the requirement for medial malleolar fixation in unstable ankle fractures. Trial registration ClinicalTrials.gov, NCT03362229. Registered retrospectively on 5 December 2017. |
| first_indexed | 2024-12-13T10:04:28Z |
| format | Article |
| id | doaj.art-54e93c75ac9649248810fe1ade52df6c |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-13T10:04:28Z |
| publishDate | 2019-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-54e93c75ac9649248810fe1ade52df6c2022-12-21T23:51:34ZengBMCTrials1745-62152019-09-012011910.1186/s13063-019-3642-7Medial malleolus: Operative Or Non-operative (MOON) trial protocol - a prospective randomised controlled trial of operative versus non-operative management of associated medial malleolus fractures in unstable fractures of the ankleThomas H. Carter0William M. Oliver1Catriona Graham2Andrew D. Duckworth3Timothy O. White4Edinburgh Orthopaedic Trauma, Royal Infirmary of EdinburghEdinburgh Orthopaedic Trauma, Royal Infirmary of EdinburghWellcome Trust Clinical Research Facility, Western General HospitalEdinburgh Orthopaedic Trauma, Royal Infirmary of EdinburghEdinburgh Orthopaedic Trauma, Royal Infirmary of EdinburghAbstract Background There are limited data reporting the outcome of patients with non-operatively managed medial malleolus fractures compared to those treated surgically in the presence of fibular stabilisation for unstable fractures of the ankle. Conservative management could result in fewer complications, reduced surgical time and lower cost. The purpose of this study is to determine if any difference exists in patient reported and surgical outcomes 1 year after surgery between operative and non-operative treatment of medial malleolar fractures in combination with stabilisation of the lateral malleolus. Methods/design This is a single-centre, prospective, randomised controlled trial that aims to randomise 154 participants with an unstable ankle fracture to ‘non-fixation’ (n = 77) or ‘fixation’ (n = 77) of an associated well-reduced medial malleolus fracture following fibular stabilisation. The study will include patients ≥ 16 years of age with a closed bimalleolar or trimalleolar ankle fracture who are able to consent, complete questionnaires in the English language, and complete follow-up over a 1-year period. Randomisation will occur intra-operatively when the medial malleolus fracture is deemed ‘well-reduced’, with 2 mm or less of fluoroscopic displacement. The technique for fixation of both the medial and lateral malleoli is at the discretion of the operating surgeon. Patient-reported, observer-rated, and radiographic assessments will be collected at baseline and then at the following post-operative assessment points: 2 weeks, 6 weeks and 1 year. Postal questionnaire outcome data will be collected at 3 and 6 months. The primary outcome measure will be the Olerud Molander Ankle Score (OMAS) at 1 year following surgery. Secondary outcome measures will include the Manchester-Oxford Foot Questionnaire (MOXFQ), EuroQol-5D (EQ-5D), pain, treatment satisfaction, time to return to activity, operative tourniquet time, and complications. Discussion There is only one previous randomised trial comparing non-fixation with fixation of associated medial malleolus fractures but that was limited by the lack of baseline patient-reported outcome data and an inferior sample size. This current prospective trial aims to provide high-quality evidence regarding the requirement for medial malleolar fixation in unstable ankle fractures. Trial registration ClinicalTrials.gov, NCT03362229. Registered retrospectively on 5 December 2017.http://link.springer.com/article/10.1186/s13063-019-3642-7Randomised controlled trialAnkle fracturesMedial malleolusFracture fixationTraumaPatient outcome |
| spellingShingle | Thomas H. Carter William M. Oliver Catriona Graham Andrew D. Duckworth Timothy O. White Medial malleolus: Operative Or Non-operative (MOON) trial protocol - a prospective randomised controlled trial of operative versus non-operative management of associated medial malleolus fractures in unstable fractures of the ankle Trials Randomised controlled trial Ankle fractures Medial malleolus Fracture fixation Trauma Patient outcome |
| title | Medial malleolus: Operative Or Non-operative (MOON) trial protocol - a prospective randomised controlled trial of operative versus non-operative management of associated medial malleolus fractures in unstable fractures of the ankle |
| title_full | Medial malleolus: Operative Or Non-operative (MOON) trial protocol - a prospective randomised controlled trial of operative versus non-operative management of associated medial malleolus fractures in unstable fractures of the ankle |
| title_fullStr | Medial malleolus: Operative Or Non-operative (MOON) trial protocol - a prospective randomised controlled trial of operative versus non-operative management of associated medial malleolus fractures in unstable fractures of the ankle |
| title_full_unstemmed | Medial malleolus: Operative Or Non-operative (MOON) trial protocol - a prospective randomised controlled trial of operative versus non-operative management of associated medial malleolus fractures in unstable fractures of the ankle |
| title_short | Medial malleolus: Operative Or Non-operative (MOON) trial protocol - a prospective randomised controlled trial of operative versus non-operative management of associated medial malleolus fractures in unstable fractures of the ankle |
| title_sort | medial malleolus operative or non operative moon trial protocol a prospective randomised controlled trial of operative versus non operative management of associated medial malleolus fractures in unstable fractures of the ankle |
| topic | Randomised controlled trial Ankle fractures Medial malleolus Fracture fixation Trauma Patient outcome |
| url | http://link.springer.com/article/10.1186/s13063-019-3642-7 |
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