Surgery versus non-operative treatment for ER-stress unstable Weber-B unimalleolar fractures : A study protocol for a prospective randomized non-inferiority (Super-Fin) trial

Publisher Copyright: ©Roughly two-thirds of ankle fractures are unimalleolar injuries, the Weber B-type fibula fracture being by far the most common type. Depending on the trauma and the accompanying soft-tissue injury, these fractures are either stable or unstable. Current clinical practice guidelines recommend surgical treatment for unstable Weber B-type fibula fractures. An ongoing randomized, parallel group, non-inferiority trial comparing surgery and non-operative treatment for unstable Weber B-type ankle fractures with allocation ratio 1:1. The rationale for non-inferiority design is as follows: By being able to prove non-inferiority of non-operative treatment, we would be able to avoid complications related to surgery. However, the primary concern related to non-operative treatment is increased risks of ankle mortise incongruency, leading to secondary surgery, early post-traumatic osteoarthritis and poor function. After providing informed consent, 126 patients aged 16 years or older with an unimalleolar Weber B-type unstable fibula fracture were randomly assigned to surgery (open reduction and internal fixation) or non-operative treatment (6-week cast immobilization). We have completed the patient enrolment and are currently in the final stages of the 2-year follow-up. The primary, non-inferiority outcome is the Olerud-Molander Ankle Score (OMAS) at 2 years (primary time point). The predefined non-inferiority margin is set at 8 OMAS points. Secondary outcomes include the Foot and Ankle Score, a 100 mm Visual Analogue Scale for function and pain, the RAND-36-Item Health Survey for health-related quality-of-life, the range-of-motion of the injured ankle, malunion (ankle joint incongruity) and fracture union. Treatment-related complications and harms; symptomatic non-unions, loss of congruity of the ankle joint, reoperations and wound infections will also be recorded. We hypothesize that non-operative treatment yields non-inferior functional outcome to surgery, the current standard treatment, with no increased risk of harms.Peer reviewe

Arkivaikuttavuuden arviointi yhdellä mittarilla

Terveystaloustiede.Suomessa kehitetty 15D on jo levinnyt laajaan käyttöön. Kokemukset Husista ja Taysista osoittavat sen käyttökelpoiseksi yleisen elämänlaadun mittariksi arkivaikuttavuuden arviointiin

Arkivaikuttavuuden arviointi yhdellä mittarilla

Suomessa kehitetty 15D on jo levinnyt laajaan käyttöön. Kokemukset Husista ja Taysista osoittavat sen käyttökelpoiseksi yleisen elämänlaadun mittariksi arkivaikuttavuuden arviointiin.publishedVersio

Three week versus six week immobilisation for stable Weber B type ankle fractures : randomised, multicentre, non-inferiority clinical trial

OBJECTIVE To 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. DESIGN Randomised, pragmatic, non-inferiority, clinical trial with blinded outcome assessment. SETTING Two major trauma centres in Finland, 22 December 2012 to 6 June 2016. PARTICIPANTS 247 skeletally mature patients aged 16 years or older with an isolated Weber B type fibula fracture and congruent ankle mortise in static ankle radiographs. INTERVENTIONS Participants 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 MEASURES The 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. RESULTS 212 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. CONCLUSION Immobilisation 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.Peer reviewe

Three week versus six week immobilisation for stable Weber B type ankle fractures : randomised, multicentre, non-inferiority clinical trial

OBJECTIVE To 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. DESIGN Randomised, pragmatic, non-inferiority, clinical trial with blinded outcome assessment. SETTING Two major trauma centres in Finland, 22 December 2012 to 6 June 2016. PARTICIPANTS 247 skeletally mature patients aged 16 years or older with an isolated Weber B type fibula fracture and congruent ankle mortise in static ankle radiographs. INTERVENTIONS Participants 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 MEASURES The 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. RESULTS 212 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. CONCLUSION Immobilisation 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.Peer reviewe

Comparison of Variable-Number Tandem-Repeat Markers typing and IS1245 Restriction Fragment Length Polymorphism fingerprinting of Mycobacterium avium subsp hominissuis from human and porcine origins

Peer reviewe

Syndesmotic Fixation in Supination-External Rotation Ankle Fractures: A Prospective Randomized Study

Article Ankle fractures are the most common injuries treated operatively by orthopedic surgeons

Seurantakäsikirja Suomen merenhoitosuunnitelman seurantaohjelmaan vuosille 2020–2026

Tämä merenhoidon seurantakäsikirja käsittää merenhoitosuunnitelman seurantaohjelman kuvauksen kokonaisuudessaan. Se päivittää vuoden 2014–2020 seurantaohjelman ja sitä sovelletaan vuoden 2020 heinäkuusta vuoden 2026 heinäkuuhun. Seurantaohjelma on osa merenhoidon suunnittelua, jota tehdään vesienhoidon ja merenhoidon järjestämisestä annetun lain (272/2011) ja merenhoidon järjestämisestä annetun valtioneuvoston asetuksen (980/2011) toteuttamiseksi. Tämä laki ja asetus on annettu meristrategiadirektiivin (Euroopan parlamentin ja neuvoston direktiivi 2008/56/EY yhteisön meriympäristöpolitiikan puitteista) kansallista toimeenpanoa varten. Suomessa meristrategiadirektiivin mukaista meristrategiaa kutsutaan merenhoitosuunnitelmaksi. Suomen seurantaohjelma koostuu 13:sta ohjelmasta, joiden alla on yhteensä 44 alaohjelmaa. Tähän päivitettyyn seurantaohjelmaan lisättiin kuusi uutta alaohjelmaa ja useita alaohjelmia muokattiin joko muuttuneiden vaatimusten, kehittyneempien menetelmien tai muuttuneen toimintaympäristön takia. Merenhoidon uusia vaatimuksia ovat meristrategiadirektiivin liitteen 3 päivitys (EU/2017/845), Euroopan komission päätös EU/2017/848 merivesien hyvän ekologisen tilan vertailuperusteista ja menetelmästandardeista sekä seurantaa ja arviointia varten tarkoitetut täsmennykset standardoiduista menetelmistä. Seurantakäsikirja koostuu kolmesta osasta: seurantaohjelman tausta, varsinainen seurantaohjelma, ja kolmas osa, joka käsittelee seurannan kehitystarpeita, kustannuksia ja riittävyyttä. Seurantaohjelma kattaa ekosysteemilähestymistavan mukaisesti erilaisia muuttujia, jotka kuvaavat toisaalta veden ominaisuuksia ja laatua ja toisaalta ekosysteemin osia ja niiden tilaa sekä niihin kohdistuvia ihmisestä johtuvia paineita. Seurannan alaohjelmissa on kuvattu mitattavat meriympäristön ominaisuudet tai paineet, niiden seurantatiheys, indikaattorit, joihin seurantatietoa käytetään, seurannalla kootun tiedon hallinta ja yhteydet meristrategiadirektiivin hyvän tilan laadullisiin kuvaajiin ja kriteereihin