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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 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.

SUBMITTER: Carter TH

PROVIDER: S-EPMC6739910 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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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.

Carter Thomas H TH Oliver William M WM Graham Catriona C Duckworth Andrew D AD White Timothy O TO

Trials 20190912 1

<h4>Background</h4>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 no ...[more]

PMID: 31514744

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Project description:ImportanceUnstable ankle fractures are routinely managed operatively. However, because of soft tissue and implant-related complications, recent literature has reported on the nonoperative management of well-reduced medial malleolus fractures after fibular stabilization, but with limited evidence supporting the routine application.ObjectiveTo assess the superiority of internal fixation of well-reduced (displacement ≤2 mm) medial malleolus fractures compared with nonfixation after fibular stabilization.Design, setting, and participantsThis superiority, pragmatic, parallel, prospective randomized clinical trial was conducted from October 1, 2017, to August 31, 2021. A total of 154 adult participants (≥16 years) with a closed, unstable bimalleolar or trimalleolar ankle fracture requiring surgery at an academic major trauma center in the UK were assessed. Exclusion criteria included injuries with no medial-sided fracture, open fractures, neurovascular injury, and the inability to comply with follow-up. Data analysis was performed in July 2022 and confirmed in September 2023.InterventionsOnce the lateral (and where appropriate, posterior) malleolus had been fixed and satisfactory intraoperative reduction of the medial malleolus fracture was confirmed by the operating surgeon, participants were randomly allocated to fixation (n = 78) or nonfixation (n = 76) of the medial malleolus.Main outcome and measureOlerud-Molander Ankle Score (OMAS) 1 year after randomization (range, 0-100 points, with 0 indicating worst possible outcome and 100 indicating best possible outcome).ResultsAmong 154 randomized participants (mean [SD] age, 56.5 [16.7] years; 119 [77%] female), 144 (94%) completed the trial. At 1 year, the median OMAS was 80.0 (IQR, 60.0-90.0) in the fixation group compared with 72.5 (IQR, 55.0-90.0) in the nonfixation group (P = .17). Complication rates were comparable. Significantly more patients in the nonfixation group developed a radiographic nonunion (20% vs 0%; P < .001), with 8 of 13 clinically asymptomatic; 1 patient required surgical reintervention for this. Fracture type and reduction quality appeared to influence fracture union and patient outcome.Conclusions and relevanceIn this randomized clinical trial comparing internal fixation of well-reduced medial malleolus fractures with nonfixation, after fibular stabilization, fixation was not superior according to the primary outcome. However, 1 in 5 patients developed a radiographic nonunion after nonfixation, and although the reintervention rate to manage this was low, the future implications are unknown. These results support selective nonfixation of anatomically reduced medial malleolar fractures after fibular stabilization.Trial registrationClinicalTrials.gov Identifier: NCT03362229.

Project description:BackgroundIn the past, posterior malleolus fragments (PMFs) commonly have been indirectly reduced and fixed when fragments involve 25% or more of the tibial articular surface, while smaller fragments were left unfixed. The posterior approach has become increasingly popular and allows fixation of even smaller fragments. This study compares clinical outcome for the 2 treatment strategies.MethodsPatients with ankle fractures involving a PMF treated from 2014 to 2016 were eligible for inclusion. Patients were allocated to group A (treated with a posterior approach) or group B (treated with the traditional approach) according to the treatment given. A one-to-one matching of patients from each group based on the size of the PMF was performed. Patient charts were reviewed, and outcome evaluation was performed clinically, radiographically, and by patient-reported outcome measures (PROMs; Self-Reported Foot and Ankle Score, RAND-36, visual analog scale [VAS] of pain, and VAS of satisfaction). Forty-three patients from each group were matched. Median follow-up was 26 (interquartile range [IQR], 19-35) months postoperatively.ResultsThe median PMF size was 17% (IQR, 12-24) in both groups, and they reported similar results in terms of PROMs. Fixation of the PMF was performed in 42 of 43 (98%) patients in group A and 7 of 43 (16%) patients in group B (P < .001). The former group more frequently got temporary external fixation (56% vs 12%, P < .01) and less frequently had syndesmotic fixation (14% vs 49%, P < .01), and they had less mechanical irritation and hardware removal but more noninfectious skin problems (28% vs 5%, P < .01). Median time from injury to definitive surgery (8 vs 0 days, P < .001) and median length of stay (12 vs 3 days, P < .001) were longer in group A.ConclusionComparison of treatment strategies for ankle fractures involving the posterior malleolus showed similar results between patients treated with a traditional approach and a posterior approach.Level of evidenceLevel III, retrospective comparative study.

Project description:BackgroundTibiotalocalcaneal (TTC) intramedullary nailing has been suggested as an alternative to open reduction and internal fixation (ORIF) for the primary treatment of unstable fragility ankle fractures with a poor soft tissue envelope. This study aims to investigate the clinical efficacy of TTC intramedullary nail fixation for the primary treatment of unstable ankle fractures in frail elderly patients with poor soft tissue condition, by assessing the number of postoperative complications and the patient-reported functional outcomes.MethodsA retrospective cohort study was performed including patients with an unstable ankle fracture treated between 2015 and 2019 with TTC stabilization using a retrograde intramedullary hindfoot nail that was inserted without joint preparation and allowing immediate weight-bearing postoperatively. The primary outcome was the total number of postoperative complications.ResultsA total of 10 patients were included out of 365 operatively treated ankle fractures. The mean age was 85.2 years (range 66-92) with a mean follow-up of 11.2 months (range 6-16). Fracture types included AO/OTA 44-B2 (n = 1), 44-B3 (n = 6), 44-C1 (n = 2) and 44-C3 (n = 1). Postoperative complications were observed in 4 patients (40%), including 3 nonunions, 2 implant related complications and 1 wound infection. No wound healing disorder or below-the-knee amputation was observed. Four patients (40%) deceased between post-operative 6 to 16 months due to medical conditions unrelated to surgery. The mean Foot and Ankle Outcome Score was 52.6 (range 44.2-73.8).ConclusionHindfoot nailingis a viable treatment option in selected high-risk patients with an advanced age, unstable ankle fractures with significant bone loss, poor soft tissue condition and/or severely impaired pre-injury mobility. In a frail geriatric population, hindfoot nailing may be a safe alternative fixation method with a low risk of wound complication or major amputation. However, unprepared joint may lead to symptomatic nonunion after TTC intramedullary nailing.

Project description:ObjectiveTo determine whether treatment of isolated stable Weber B type ankle fractures with a cast or a simple orthotic device for three weeks produces non-inferior outcomes compared with conventional immobilisation in a cast for six weeks.DesignRandomised, pragmatic, non-inferiority, clinical trial with blinded outcome assessment.SettingTwo major trauma centres in Finland, 22 December 2012 to 6 June 2016.Participants247 skeletally mature patients aged 16 years or older with an isolated Weber B type fibula fracture and congruent ankle mortise in static ankle radiographs.InterventionsParticipants were randomly allocated to conventional six week cast immobilisation (n=84) or three week treatment either in a cast (n=83) or in a simple orthosis (n=80).Main outcome measuresThe primary, non-inferiority, intention-to-treat outcome was the Olerud-Molander Ankle Score at 12 months (OMAS; range 0-100; higher scores indicate better outcomes and fewer symptoms). The predefined non-inferiority margin for the primary outcome was -8.8 points. Secondary outcomes were ankle function, pain, quality of life, ankle motion, and radiographic outcome. Follow-up assessments were performed at 6, 12, and 52 weeks.Results212 of 247 randomised participants (86%) completed the study. At 52 weeks, the mean OMAS was 87.6 (SD 18.3) in the six week cast group, 91.7 (SD 12.9) in the three week cast group, and 89.8 (SD 18.4) in the three week orthosis group. The between group difference at 52 weeks for the three week cast versus six week cast was 3.6 points (95% confidence interval -1.9 to 9.1, P=0.20), and for the three week orthosis versus six week cast was 1.7 points (-4.0 to 7.3, P=0.56). In both comparisons, the confidence intervals did not include the predefined inferiority margin of -8.8 points. The only statistically significant between group differences observed in the secondary outcomes and harms in the two primary comparisons were slight improvement in ankle plantar flexion and incidence of deep vein thrombosis, both in the three week orthosis group versus six week cast group.ConclusionImmobilisation for three weeks with a cast or orthosis was non-inferior to conventional cast immobilisation for six weeks in the treatment of an isolated stable Weber B type fracture.Trial registrationClinicalTrials.gov NCT01758835.

Project description:BackgroundHumeral shaft fractures constitute around 1% of adult fractures in the UK, with an annual incidence of approximately 13 per 100,000 population. Historically, these injuries have been primarily managed non-operatively, with operative fixation reserved for specific indications. Although some recent retrospective studies have suggested there are potential benefits of operative fixation over humeral bracing, there is a deficiency in level 1 evidence to support operative management as the primary treatment for humeral shaft fractures.Methods/designThis single-centre prospective randomised controlled trial aims to recruit 70 adult patients with an isolated closed fracture of the humeral diaphysis into one of two treatment arms: operative (n = 35) or non-operative (n = 35). The operative arm will undergo open reduction and internal fixation (ORIF) of the fracture using a standard fixation technique (plate and screws). The non-operative arm will be fitted with a prefabricated humeral brace until fracture union. All patients will be followed up for 1 year post-intervention. The primary outcome measure will be the Disabilities of the Arm, Shoulder and Hand (DASH) score at 3 months post-intervention. Secondary outcome measures will include pain, treatment complications, return to work or sporting activities, shoulder and elbow range of motion, radiographic assessment, EuroQol (EQ-5D) Health Outcome score and 12-item Short Form (SF-12) Health Survey score. A health economic analysis will be performed to compare the cost implications of each treatment strategy.DiscussionThis randomised controlled trial will provide level 1 evidence comparing a standard ORIF technique against functional bracing for isolated closed humeral shaft fractures. The investigators hope that the study results will assist surgeons in their decision-making when managing patients with these injuries.Trial registrationClinicalTrials.gov, NCT03689335 . Registered on 28 September 2018 (retrospectively).

Dataset Information

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.

Publications

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.

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