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

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

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

The non-operative treatment of Weber B -type ankle fractures and the clinical relevance and treatment of syndesmosis injury

Abstract Despite numerous biomechanical and clinical studies on ankle fractures, the optimal treatment method for a stable fibula fracture is poorly known. Additionally, the clinical relevance and optimal fixation method of syndesmosis injury for different ankle fracture types is unclear. This thesis aimed: (I) to compare six weeks of cast immobilization with three weeks of immobilization (cast or orthosis) in a randomized controlled trial (RCT) of 247 patients with stable Weber B-type fibular fracture; (II) to compare mid-term outcome of syndesmosis transfixation with no fixation in an RCT of 24 patients with supination external rotation (SER) ankle fractures and syndesmosis injury; (III) to evaluate the significance of the syndesmosis injury on clinical outcome in a case-control study of 48 patients with SER ankle fractures; and (IV) to compare the syndesmosis fixation with a screw versus a suture-button device in terms of the accuracy and the maintenance of syndesmosis reduction in an RCT of 43 patients with pronation external rotation (PER) ankle fractures. Three weeks of immobilization in either a cast or an orthosis resulted in non-inferior outcomes compared to traditional six weeks’ immobilization in patients with stable Weber B-type fibula fracture. In patients with SER ankle fracture and unstable syndesmosis after fixation of bone fractures, leaving unstable syndesmosis unfixed resulted in similar outcomes compared to syndesmosis transfixation at mid-term follow-up. Patients with SER ankle fractures with or without an associated syndesmosis injury had similar clinical outcomes after a minimum of four years of follow-up. The syndesmotic screw and the suture-button fixation in patients with PER ankle fracture and unstable syndesmosis resulted in a low malreduction rate and both methods maintained reduction well. In conclusion, stable Weber B-type fibula fractures can safely be treated with only three weeks of cast immobilization or even with a simple orthosis. A syndesmosis injury in SER ankle fractures seems to be of minor therapeutic or prognostic importance and syndesmosis screw fixation has no effect on patient’s recovery compared to no syndesmosis fixation. An associated syndesmosis injury in PER ankle fractures can be fixed with a syndesmotic screw or a suture-button device with comparable outcomes.Tiivistelmä Stabiilin nilkkamurtuman konservatiivisen hoidon toteutuksesta on hyvälaatuista tutkimustietoa tarjolla niukasti. Syndesmoosivamman kliininen merkitys ja sen hoitomenetelmät eri nilkkamurtumatyypeissä ovat kirjallisuuden perusteella vielä osittain epäselvät. Ensimmäisessä osatyössä vertailtiin kolmen viikon immobilisaatiota (kipsi tai ortoosi) perinteiseen kuuden viikon kipsihoitoon satunnaistetussa ja kontrolloidussa tutkimuksessa, joka käsitti 247 stabiilin Weber B-tyypin pohjeluun murtuman saanutta potilasta. Toisessa osatyössä vertailtiin syndesmoosin ruuvikiinnitystä kiinnittämättä jättämiseen satunnaistetussa ja kontrolloidussa tutkimuksessa, johon osallistui 24 SER (supinaatio-ulkorotaatio) -tyypin nilkkamurtumapotilasta, joilla todettiin syndesmoosin epävakaus leikkauksen aikaisessa rasituskokeessa. Kolmannessa osatyössä selvitettiin syndesmoosivamman kliinistä merkitystä SER-tyypin nilkkamurtumapotilailla tapaus-verrokki-asetelmassa. Neljännessä osatyössä vertailtiin syndesmoosin ruuvi- ja jännitelankakiinnitystä syndesmoosin kiinnitystarkkuuden ja kiinnityksen pysyvyyden suhteen satunnaistetussa ja kontrolloidussa tutkimuksessa, joka käsitti 43 PER (pronaatio-ulkorotaatio) -tyypin nilkkamurtuman saanutta potilasta. Stabiilin Weber B-tyypin pohjeluun murtuman hoidossa kolmen viikon immobilisaatio joko kipsillä tai ortoosilla oli yhtä hyvä ja turvallinen kuin perinteinen kuuden viikon kipsihoito. Syndesmoosin ruuvikiinnitettyjen ja kiinnittämättä jätettyjen SER-tyypin nilkkamurtumapotilaiden hoitotuloksissa ei todettu merkittäviä eroja keskipitkän aikavälin seurannassa. Syndesmoosivammalla ei todettu merkitystä SER-tyypin nilkkamurtuma-potilaiden hoitotulokseen tai ennusteeseen vähintään neljän vuoden seurannan jälkeen. Syndesmoosin reduktion suhteen ruuvi- ja jännitelankakiinnityksellä saadaan yhtä hyvät varhaisvaiheen tulokset PER-tyypin nilkkamurtumapotilailla ja molemmat kiinnitysmenetelmät säilyttävät syndesmoosin reduktion hyvin. Stabiilin Weber B -tyypin pohjeluun murtuman hoito voidaan toteuttaa turvallisesti ja tehokkaasti kolmen viikon immobilisaatiolla joko nilkkaortoosilla tai saapaskipsillä. Syndesmoosivammalla ei vaikuta olevan kliinistä merkitystä SER-tyypin nilkkamurtumapotilaan ennusteeseen, eikä vamman hoitaminen ruuvikiinnityksellä paranna potilaan hoitotulosta kiinnittämättä jättämiseen verrattuna. PER-tyypin nilkkamurtumiin liittyvän syndesmoosivamman korjauksessa voidaan käyttää joko ruuvikiinnitystä tai jännitelankasidosta yhtä hyvin hoitotuloksin

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

Abstract 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

Suture button versus syndesmosis screw fixation in pronation-external rotation ankle fractures:a minimum 6-year follow-up of a randomised controlled trial

Abstract Objective: Randomised controlled trials (RCT) with short-term follow-ups have shown that, in treatment of syndesmosis injuries, a suture button device (SB) resulted in better radiographic and functional outcome compared to syndesmosis screw fixation (SS). However, only one RCT has reported long-term results; thus, the syndesmosis malreduction rates for both implants might increase during longer follow-up. The primary objective of this RCT was to evaluate the maintenance of syndesmosis reduction with the SS compared to the SB fixation in patients during a minimum follow-up of 6-years. The secondary objectives were to assess the post-traumatic osteoarthritis (OA) grade and the functional outcome. Patients and Methods: At Oulu University Hospital, between January 2010 and December 2011, we enrolled 43 patients with Lauge-Hansen pronation-external rotation type 4/Weber C, ankle fractures with unstable syndesmosis. Patients were randomised to treatment with either a single 3.5-mm tricortical SS (22 patients) or an SB (21 patients). The mean follow-up was 7.1 years (range, 6.2—7.9). Syndesmosis reduction and OA grade was assessed with standing cone-beam computed tomography (CBCT) of both ankles. Malreduction was defined as >2 mm side-to-side difference in the mean width of the syndesmosis. OA was graded according to the Morrey & Wiedeman classification. The Olerud-Molander Ankle Outcome Score (OMAS) and a quality of life questionnaire (RAND 36-Item Health Survey) were used to evaluate functional outcome. Results: Two syndesmoses in the SS group and one in the SB group were malreduced (P = 0.58). Moderate OA after a mean of 7 years post-injury was common. In the SS and SB groups, 9 of 16 and 11 of 13 patients, respectively, had one or more grades serious OA in the injured ankle than in the uninjured ankle (P = 0.11). The mean OMAS was 88 in the SS group and 78 in the SB group (difference between means 7.1, 95% CI: −7.0–21.1, P = 0.32). The RAND-36 results did not differ between groups. Conclusion: The SS and SB maintained syndesmosis reduction equally well during follow-up. Our study findings also suggest that both methods result in moderate OA rates and the functional outcome is comparable between these two syndesmosis fixation methods

Syndesmosis fixation in supination-external rotation ankle fractures:long-term results of a prospective randomised study

Abstract Background: The clinical relevance and treatment of syndesmosis injury in supination-external rotation (SER) ankle fractures are controversial. Methods: After malleolar fixation 24 SER 4 ankle fracture patients with unstable syndesmosis in external rotation stress test were randomised to syndesmosis transfixation with a screw (13 patients) or no fixation (11 patients). Mean follow-up time was 9.7 years (range, 8.9–11.0). The primary outcome measure was the Olerud-Molander Ankle Outcome Score (OMAS). Secondary outcome measures included ankle mortise congruity and degenerative osteoarthritis, 100-mm visual analogue scale for function and pain, RAND 36-Item Health Survey, and range of motion. Results: Mean OMAS in the syndesmosis transfixation group was 87.3 (SD 15.5) and in the no-syndesmosis-fixation group 89.0 (SD 16.0) (difference between means 1.8, 95% CI −10.4–14.0, P = 0.76). There were no differences between the two groups in secondary outcome measures. Conclusions: With the numbers available, SER 4 ankle fractures with unstable syndesmosis can be treated with malleolar fixation only, with good to excellent long-term functional outcome

Difference in postoperative opioid consumption after spinal versus general anaesthesia for ankle fracture surgery:a retrospective cohort study

Abstract Background: Surgical treatment of ankle fracture is associated with significant pain and high postoperative opioid consumption. The anaesthesia method may affect early postoperative pain. The main objective of the study was to compare postoperative opioid consumption after ankle-fracture surgery between patients treated with spinal anaesthesia and general anaesthesia. Methods: We reviewed retrospectively the files of 586 adult patients with surgically treated ankle fracture in the years 2014 through 2016. The primary outcome was opioid consumption during the first 48 postoperative hours. Secondary outcomes were maximal pain scores, postoperative nausea and vomiting, the length of stay in the post-anaesthesia care unit, and opioid use in different time periods up to 48 h postoperatively. Propensity score matching was used to mitigate confounding variables. Results: Total opioid consumption 48 h postoperatively was significantly lower after spinal anaesthesia (propensity score-matched population: effect size −13.7 milligrams; 95% CI −18.8 to −8.5; P < .001). The highest pain score on the numerical rating scale in the post-anaesthesia care unit was significantly higher after general anaesthesia (propensity score-matched population: effect size 3.7 points; 95% CI 3.2-4.2; P < .001). A total of 60 patients had postoperative nausea and vomiting in the post-anaesthesia care unit, 53 (88.3%) of whom had general anaesthesia (P = .001). Conclusions: Patients with surgically treated ankle fracture whose operation was performed under general anaesthesia used significantly more opioids in the first 48 h postoperatively, predominantly in the post-anaesthesia care unit, compared with patients given spinal anaesthesia